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ImpactMonitor and its relevance for future therapy management.

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ImpactMonitor and its relevance for future therapy management

26.01.2021

As a platform provider we connect patients, medical professionals and pharmaceutical manufacturers through our state-of-the-art communication infrastructure. Our goal is to collect and subsequently provide information on drug efficacy and safety, in real time from real-world care. 

To this end, we use standardized measurement tools, so-called Patient-Reported Outcome Measures (PROM), to capture user experiences. With the development of the ImpactMonitor, life science companies can now make use of our simple, digital and efficient web application when bringing new therapies to market.

What is the ImpactMonitor used for ?

With ImpactMonitor, we offer pharmaceutical companies the opportunity to gain data-driven insights into the drug efficacy and safety of their pharmaceuticals. This is particularly useful for drugs that have received a conditional marketing authorization and therefore need to be monitored during use. Such data collection and analysis is possible via the simple, cost-effective and flexible scalable ImpactMonitor. 

For optimal therapy or drug monitoring, standardized and scientifically developed measurement instruments for recording patient experience (PROM) can be used on a regular basis. These can be easily implemented via ImpactMonitor, broadcast to thousands to millions of users, and analyzed. In the process, any new adverse events can also be reported immediately and communicated to affected individuals in the shortest possible time.

The use of the ImpactMonitor is very simple: 

As soon as a patient is prescribed a new drug or a new therapy, he or she is informed by the doctor about the possibility of data collection accompanying the application. Using a QR code or even entering the website link directly, the patient can register online for the program and immediately enjoy all the benefits.

ImpactMonitor ultimately functions as a reliable, digital companion for patients and includes the following 4 main functions:

1. Dosage and Intake

Patients have the possibility to get information about the individual intake and dosage of the medication at a glance via the ImpactMonitor. These are given directly by the manufacturer or medical experts. Depending on the medication and the person, the recommended dosage and intake may differ. As a kind of “digital instruction leaflet”, the patient now has all the important information directly at hand.

2. Push Notifications for maximum safety

If new, unknown side effects occur, pharmaceutical manufacturers need to act as quickly as possible. The ImpactMonitor notifies other patients via push notifications when such side effects become known. This makes an effective contribution to overall patient safety. Such an approach also not only builds trust between patients and pharmaceutical manufacturers, but also contributes to therapy adherence.

3. Real-World-Evidence

During therapy, patients can view the therapy progress of other patients and compare their own tolerability profile with them. Under the keyword “relative expectation management”, patients are optimally prepared for therapy by transparently displaying tolerance profiles and thus promoting adherence to medication.

Read more about Real-World-Evidence.

4. Online Support

In addition to tracking drug efficacy, ImpactMonitor also provides a multilateral communication infrastructure. Patients can communicate directly with physicians or pharmaceutical manufacturers. For minor concerns, patients can also contact our experts. Sometimes quick answers are enough to significantly increase patient satisfaction.

Conclusion for the use of the ImpactMonitor

Effective drug monitoring requires extensive communication among all medical professionals as well as patient involvement. No one can provide more valid real-world data than the patient himself. ImpactMonitor combines these features in a unique platform solution.

Generating Real-World-Evidence 

→ Through PROM, real-world data is collected in a structured way and immediately analyzed.

Direct patient support

→ By involving medical professionals, patients get quick answers when they have questions. An interface to telemedicine services is also possible.

Relative expectation management

→ Already in advance the patient knows, through RWE, which (side) effects are to be expected, therefore a significantly higher adherence to medication can be expected.

Opportunities for precision medicine

→ By evaluating thousands of therapy reports, ImpactMonitor can generate indications and therapy recommendations for specific patient groups. This allows for much more specific interactions in the therapy process.

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Real-World-Evidence – What is it and what can it tell us?

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Real-World-Evidence – What is it and what can it tell us?

11.01.2021

Real-World-Evidence (RWE) has become a trendy term in medicine in recent years. However, the term is difficult to grasp and define. We have tried to do so and explain what Real-World-Evidence means, what role we play in it and why RWE is the future for evidence-based medicine.

What exactly is RWE and how is it collected?

RWE generally describes “the representation of the reality of (health-)care through mass data sources” (Behrendt, 2019). A cornerstone of this is the collection of meaningful data on drug efficacy in practice. To date, RWE generation has been limited to registry data. Registry data are data sets that are collected for various purposes and systematically stored in databases. Mostly, they are data sets that are used for billing drug therapies. 

These data sets include, among others, insured person master data (gender, age, highest qualification level…), ICD diagnosis data and inpatient stays in hospitals. Clinical staff collect these data manually and transmit them to the respective registers, i.e. the database of the collecting institution (e.g. health insurance companies). Since this is a more or less voluntary, non-standardized survey, the completeness of these data is relatively low. Another problem is that these data are originally collected for the purpose of billing services and drug monitoring, which is very different from the intended use of research. Visibly, voices from the healthcare industry are growing louder for a uniform, standardized data collection.

In addition to the main method of generating Real-World-Evidence, the FDA proposes these other methods:

  1. Data from electronic health records
  2. Data from product and disease registries
  3. Data privately generated by the patient, eg. data from other sources that can provide information about health status, such as mobile devices

The role of XO Life in real-world care settings

XO Life takes a major step forward, by providing an innovative communication platform through which high-quality data from real-world care settings on the effects and side effects of drug therapies are collected. The primary goal is to standardize the data sets and make them available in real time to all affected individuals as well as medical professionals and research companies. 

This will provide another information base, through Patient Reported Outcomes (PRO), in drug therapy decisions. After all, Big Data is not much use if it is neither structured, nor accessible. Monitoring the effectiveness of drug therapies is thus to be digitized, simplified and made more cost-effective. At the same time, the large amount of data increases the possibility of applying precision medicine, which will become increasingly important in the future. In this way, treatment strategies and therapies can be individually tailored. Of course, under the strictest data protection and in compliance with all regulations of the DSGVO.

Real-world evidence as a supplement to the clinical “gold standard” of randomized controlled trials (RCT)

RWE is ideal for shaping the future of evidence-based medicine alongside time-tested research approaches (RCTs) for the reasons outlined above. For example, the time and money involved in RCT studies is not always appropriate.

RCTs are the gold standard for clinical trials. Randomized controlled treatment groups are used. A randomly selected treatment group receives either the drug or a placebo. This study design, conducted as an experiment, is, in evidence-based medicine, particularly suitable for obtaining causality, i.e. an unambiguous answer from an unambiguous question.

However, in addition to these advantages, RCTs also have serious disadvantages, which is why they are not appropriate in some cases. RCTs are often associated with high financial and time costs. In addition, high inclusion criteria reduce the external validity, i.e. the agreement of the results with the overall population. In addition, there is a tight time limit. This is particularly the case for orphan drugs.

Even at the present time, the issue is more topical than ever, now that the first vaccines against the corona virus have been approved. The rapid, conditional approval of the vaccines by the EMA often raises questions about the safety of these vaccines. Because of the limited approval, manufacturers of these pharmaceuticals must ensure in-use data collection. Ie, pharmaceutical manufacturers must continuously collect data from patients taking a drug to monitor for potential side effects. The collection of real-world evidence, e.g. through XO Life’s ImpactMonitor, promises to be an innovative way to solve this problem. Thus, the previously mentioned multitude of data collected from a wide variety of groups of people represent an important advantage of collecting RWE. RWE collected in a complementary manner to RCT studies can significantly condense the final data set. Following market approval, as soon as possible, can provide clear evidence on the benefit-risk profile of drug therapies in young and old, young and old and men and women.

Conclusion

Real-world evidence, which can be generated e.g. via ImpactMonitor, will play a major role in many areas of evidence-based medicine in the future. For example, it helps drug manufacturers to learn more quickly about drug effects and side effects. By seamlessly integrating the ImpactMonitor into existing processes, we support research institutes and manufacturers in collecting the necessary data. In addition, real-world evidence can be collected more quickly when RCT studies on new drugs are not appropriate, e.g. due to time limitations. Thus, our platform makes a significant contribution to drug safety and targeted individual drug prescription to patients.

Sources:

Behrendt, C.A. Was ist die Realität hinter der Real-World-Evidenz?. Gefässchirurgie 24, 7–8 (2019). Accessed at: https://link.springer.com/article/10.1007/s00772-018-0474-9; Last accessed 04.01.2021

Gliklich, Leavy, Dreyer. Registries for Evaluating Patient Outcomes: A User’s Guide (2020). Accessed at: https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/registries-evaluating-patient-outcomes-4th-edition.pdf; Last accessed 04.01.2021

U.S. Food & Drug Administration. Real-World Evidence (2020). Accessed at: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence; Last accessed 04.01.2021

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Development of Patient Reported Outcome Measures (PROM)

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Development of Patient Reported Outcome Measures (PROM)

02.08.2021

The benefits, importance and relevance of Patient Reported Outcomes (PROs) have already been discussed in a previous article. We highlighted the benefits of PROs for precision medicine, for randomised controlled trials (RCTs) and for the marketing authorisation of medicines. > Read the full article here!

Today, we want to look at this topic from a different angle and answer the question of who actually creates the questionnaires that ask for subjective patient responses. How are PROMs checked for validity, i.e., the accuracy of the match between the measurement result and the measurement construct, and reliability, i.e., the error-free measurement so that the measurements also match the population? Are there any international standards for PROMs?

To answer these questions, we start at the beginning, with the manufacturers of PROMs. In the following, we will first introduce the two most important players in the industry.

What exactly is the ICHOM initiative?

In the book “Redefining Health Care”, 2006 the authors Michael E. Porter and Elisabeth O. Teisberg introduced the concept of value-based health care. This means that health care should be oriented in such a way that it creates “value” for patients. Value is defined as the outcome of health divided by the costs spent on it.[1] The value calculation also includes, for instance, patient-reported outcomes. Ultimately, healthcare is to be focused on the value and the composition of the endpoint categories.[2] Up to now, healthcare has only paid attention to the endpoint categories mortality, i.e., the number of deaths from a certain disease per 1,000 people per year, and morbidity, i.e., the number of people who fall ill in a population per year.[2] Based on their own conviction that PROs in particular have a great additional benefit for healthcare, Porter and Teisberg, together with the Boston Consulting Group, founded the ICHOM in 2012 to collect these PROs.

ICHOM – that stands for International Consortium for Health Outcome Measurements, based in Boston, USA, develops the necessary tools to measure Patient Reported Outcomes together with patients, physicians and other industry experts. These are standardised questionnaires, so-called standard sets, which patients fill out themselves, depending on the target group and disease.[3,4] These standard sets are then used to measure subjective endpoints of therapies on the patients’ perceived quality of life. The result is then comparable in the same target group or among patients with the same disease.

What does ICHOM do?

The task of ICHOM is to firstly operationalise these questionnaires, i.e., to transform certain constructs, such as physical or mental well-being, into individual questions, i.e., items, and secondly to standardise them, i.e., to make them comparable. In addition, the ICHOM’s tasks include the definition of standard values for the individual constructs in order to be able to use them as reference values.[4] The non-profit organisation works together with researchers from different fields, patients, doctors, medical professionals and other experts in order to use the latest medical findings to develop the sets. This ensures that the standard sets are always up to date and of continuously high quality.[5]

Conclusion

In summary, the international comparability of patient self-assessment among the individual disease and target groups, along the entire treatment chain, is the central task of the ICHOM. Currently, the ICHOM offers 30 evaluated and standardised free sets covering the most important clinical syndromes.[4]

What is the PROMIS initiative?

In 2002, when the director of the National Institutes of Health (NHI) commissioned a roadmap for medical research in the 21st century over many meetings, the idea of leveraging patient-reported outcomes of chronic diseases as a new way to conduct medical research was developed.[6] Two years later, the PROMIS group was formed to turn this very idea into reality. PROMIS stands for Patient Reported Outcome Measurement Information System. This international research initiative, just like ICHOM, develops internationally standardised measurement systems for examining patient-reported outcomes.[7] The difference is that the PROMIS questionnaires are applicable to all patients, with or without disease or ongoing therapy. This means that these outcomes of evaluating physical, mental or social health are comparable among all individuals. Unlike the ICHOM sets, the PROMIS questionnaires do not depend on whether a person has an illness or what illness they have in order to obtain comparable results.[1]

National divisions of PROMIS

The international PROMIS initiative is divided into national units. In Germany, for example, there is PROMIS Germany, based at the Charité Berlin. These national units translate the individual questionnaires so that they remain internationally comparable. In addition, PROMIS Germany takes care of the validation of the sets. This means that PROMIS Germany makes sure that the questionnaires really measure the construct they are supposed to measure.

Benefits and importance of the work of PROMIS and ICHOM

In general, there is a high level of scientific interest in the PROMIS items. In the first half of 2021 alone, almost 100 studies were published that either used the PROMIS items to evaluate therapy outcomes or tested the PROMIS system for validity and confirmed its usefulness. It is important to develop such instruments because in the past a wide variety of measurement methods were developed in different medical fields, including the ICHOM sets, which measure the same characteristic but do not necessarily provide comparable results due to their disease-specific orientation. This means that physical functioning, for example, could be asked differently in the questionnaire set for one clinical picture than for another. On the one hand, this creates redundancies in the questionnaire and low comparability between patients with different clinical patterns. In addition, the quality of the different questionnaires was often very different. Today, it is recommended to use disease-unspecific items, such as those of the PROMIS, instead of disease-specific items, such as those of the ICHOM. In order to support clinical diagnostics in addition to gold standard studies (RCTs), standardised, disease-unspecific measurement systems developed by research initiatives such as the PROMIS are needed.

Conclusion

Self-reported patient outcomes collected by the two initiatives are enabling ever more individualised, precise therapy management, prognosis and screening. These measured outcomes have already become increasingly relevant in medical research and therapy evaluation in recent years. For example, the assessment of the benefit of the endpoint “quality of life” has been firmly anchored as a subjective endpoint in therapy evaluations for several years.[4] Thus, we at XO Life also consider PROs to be a useful instrument to help medicine develop even more precisely, patient-oriented and value-oriented in the future.

Sources:

[1] Terwee C.B., Zuidgeest M., Vonkeman H.E, Cella D., Haverman L., Noorda L.D. (n.d.). Common patient-reported outcomes across ICHOM Standard Sets – the potential contribution of PROMIS. https://osf.io/fbw2j/download

[2] Harvard Business School. (n.d.) International Consortium for Health Outcome Measurement. https://www.isc.hbs.edu/about-michael-porter/affiliated-organizations-institutions/Pages/ichom.aspx

[3] IQWiG. (2020) Konzepte zur Generierung versorgungsnaher Daten und deren Auswertung zum Zwecke der Nutzenbewertung von Arzneimitteln nach § 35a SGB V. https://www.iqwig.de/download/a19-43_versorgungsnahe-daten-zum-zwecke-der-nutzenbewertung_rapid-report_v1-1.pdf?rev=184598 

[4] Deutsches Ärzteblatt. (2020). Rehabilitation: Messbarer Patientennutzen als Ziel. https://www.aerzteblatt.de/archiv/212785/Rehabilitation-Messbarer-Patientennutzen-als-Ziel

[5] ICHOM. (n.d.). About Us. https://www.ichom.org/mission/#founders

[6] Cella D. et al. (2007). The Patient-Reported Outcomes Measurement Information System (PROMIS). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2829758/

[7] PROMIS. (n.d.). Hintergrund. https://promis-germany.de/ueber-promis-2/hintergrund/

[8] PROMIS. (n.d.). Publications by Year. https://www.healthmeasures.net/explore-measurement-systems/promis/measure-development-research/publications-promis

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What do life science companies actually do?

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What do life science companies actually do?

02.08.2021

Better, more innovative, more targeted and more advanced – these are all typical keywords of companies that are continuously developing new products. This development affects both start-ups and already developed (large) corporations. Between new technologies and application areas, the keyword life sciences comes up repeatedly. But what exactly are life sciences and what makes a company an innovative life science company?

What does life science actually mean?

Life sciences are a combination of interdisciplinary research fields. This includes companies in biotechnology, medical technology and pharmacy – quite broadly diversified, in other words. Areas of application in which life science companies are active include artificial intelligence, biosensor technology, skin scanning, lasik, patient monitoring and many more. We at XO Life have created an innovative, interactive, multidimensional communications platform for patient insights into therapies, which means that we can also be counted among the life science companies in medical technology (med-tech). Since patient monitoring, among other fields, is part of medical technology, the question arises as to what else is being developed in the field of medical technology in the life sciences sector.

Life science companies in med-tech:

The med-tech side of the industry is often narrowed down to the development of new devices and technologies driven by the increasingly complex needs of patients, doctors, pharmacists and the pharmaceutical industry. 

> Why medicine as a whole is becoming increasingly complex can be read here in our blog covering precision medicine. <

Typical research and development fields of life science companies are the development of instruments to diagnose, prevent, monitor and treat medical conditions. Such medical devices are either virtual or physical in nature, i. e., they can be a machine, an implant or software.

Life Science Analytics

One example for software is the category Life Science Analytics. Here, companies that specialise in the collection, analysis and utilisation of medical data are primarily engaged. Cost reductions in the health care system, improvement of therapy results and 24/7 access to health information are the three main drivers of this sector.

“By the way, the global life science analytics market is expected to be worth $18.12 bn by 2030.”[1]                                             (compared to 2019, $7.57 bn)

In addition to many start-ups like XO Life, leading tech giants are increasingly entering the life sciences sector to redefine healthcare. So far, however, none of these companies has focused more intensively on the patient side. XO Life picks up on this trend and aims to make patient demands more accessible to life science companies so that patients receive the best possible therapy. By collecting and analysing millions of patient information, we thus create resilient real-world-evidence, i.e., real evidence directly from real care, to redefine healthcare and equip it for the future.

What is the future of life sciences?

First steps in the right direction have already been taken. First start-ups with enormous potential – such as XO Life – are already working intensively on the proper development and delivery of new technologies, while large tech corporations are also advancing into the industry alongside large pharmaceutical and healthcare companies. As a result, better tools and processes are being developed faster than ever to bring all stakeholders, i.e., pharmaceutical companies, doctors and pharmacists, closer to the needs of their customers and patients.[2] Accordingly, real-world-evidence through patient insights, such as those provided by XO Life, are perfectly suited for this purpose.

Sources:

[1] Precedence Research. 2021. Life Science Analytics Market to Garner Growth 8.25% by 2030. https://www.globenewswire.com/news-release/2021/02/11/2174352/0/en/Life-Science-Analytics-Market-to-Garner-Growth-8-25-by-2030.html

[2] Shalini Sharad. n.d. PharmD. The Role of Analytics in the Life Sciences Industry. https://www.wipro.com/pharmaceutical-and-life-sciences/the-role-of-analytics-in-the-life-sciences-industry/

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Patient-Reported-Outcome-Measures in health-care.

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Patient-Reported-Outcome-Measures in health-care

15.02.2021

In an increasingly efficient world, a rethinking of the healthcare system must take place sooner or later. Due to the multitude of different patient groups and their sensitivities, an orientation towards the individual patient is indispensable. In this context, data collected by patients, so-called Patient Reported Outcome Measures (PROMs), will play an increasingly central role.

Evaluating and incorporating PROMs into healthcare enables the following benefits:

  1. Medical professionals can recognize symptoms more quickly and take targeted initiative [1]
  2. Additional evidence for market-relevant approval studies (so-called pre-market case studies) and after market approval (so-called post-marketing studies)
  3. Precise drug therapy monitoring in a real-world care setting for enabling precision medicine

But what are PRO(Ms) all about and how do they contribute to precision medicine?

What are PROs / PROMs ?

According to the European Medicine Agency (EMA), Patient Reported Outcomes (PROs) is data collected directly – by the patient [2]. In addition to regular medical questions (clinical, genetic and medical questions), subjective data on the personal perception of the disease and the associated therapy gets evaluated.

Possible endpoints of the survey include information on:

  • Impact on quality of life
  • Symptoms during therapy
  • Adherence to therapy
  • Satisfaction with the course of therapy
This data is measured using standardized, scientifically developed methods known as Patient Reported Outcome Measures.
 
The majority of PROMs are questionnaires that must fulfill the following quality characteristics [3]:
1. Comparability

The questionnaires ensure that both, a comparison between different patients (interpersonal) and a comparison of the same patients over time (intrapersonal) is possible. In addition, different disease groups and cultures can be compared.

2. Reliability and Validity

The applicability of the collected data to the population (validity) is ensured by strict standardized methods. As a result, the results of the study are also internally consistent and query those details that are to be queried (reliability).

3. Flexibility

The questions on certain characteristics (items), such as subjective perception of the therapy, can be composed freely according to the group to be examined. The questionnaire maintains full reliability and validity.

4. Integrativity

People from all groups of the population can fill out these questionnaires. Thus, consideration is given to reading ability, language and physical feasibility.

In Germany, there are currently already leading research institutes, such as the PROMIS Institute of the Charité Berlin, which develops standardized measurement instruments for patient-reported characteristics and makes them applicable in real care settings.

Importance of PROMs in clinical pre-market studies

PROMs make clinical studies more precise – individual endpoints, such as impact on quality of life, can be collected more accurately than ever before and thus form a good basis for future therapy recommendations. A self-learning system is emerging which, through more precise evidence, enables more precise diagnostics and subsequently precise treatment recommendations [6]. Thus, a significant increase in PROM items in clinical trials has been observed in recent years. In 2018, the FDA reported that in 6 years, an increase of >500% was observed in the number of pre-authorization clinical trials in the United States that included PROMs [5].

PROMs after market approval

In addition to their importance for the market approval of drugs, PROMs also help to generate relevant outcomes in the real healthcare setting. Data on subjective perception of the therapy is collected even after approval. This is often a mandatory component of new drugs that may have received conditional market approval. In addition to real-time PROM data collection, it has the advantage that patients can obtain transparent information on the therapy progress of similar patients. Thus, PROMs can significantly increase adherence to therapy through reliable expectation management.

What does XO Life contribute to the use of PROMs ? 

For this purpose, PROM questionnaires are mostly used for digital patient surveys. Using a web-based scalable application, such as ImpactMonitor, patients provide their subjective psychological and physical perceptions directly in digital form, which allow conclusions to be drawn about the effectiveness and safety of the therapy in real time. This allows precise and flexible therapy adjustments; patients can also be managed in their expectations by viewing the therapy progress of other patients. In addition, individual therapy paths can be reviewed with regard to their long-term effects by monitoring patients even after therapy.

Conclusion

With regard to the developments of regular medicine towards precision medicine, an implementation of PROMs in clinical studies as well as in everyday care will be imperative. Precise, individually adapted therapies need precise, individual and above all subjective data – which is reported from the patient – on which they can be based. With relevant items and a real-time collection of these, such a monitoring of therapies  in real-care settings can be continued.

This requires the expertise of scientific institutes such as PROMIS on the one hand, and the technical know-how of XO Life on the other. 

Sources

[1] Licqurish SM, Cook OY, Pattuwage LP, et al. Tools to facilitate communication during phy- sician-patient consultations in cancer care: An overview of systematic reviews. CA Cancer J Clin 2019;69(6):497–520

[2] European Medicines Agency: Integrating patients’ views in clinical studies of anticancer medicines. 2016. https://www.ema.europa.eu/en/news/integrating-patients-views-clinical-studies-anticancer-medicines. Last accessed: 15.02.2021

[3] PROMIS Germany: Hintergrund.  https://promis-germany.de/ueber-promis-2/hintergrund/ Last accessed: 15.02.2021

[4] Weszl, M., Rencz, F. & Brodszky, V. Is the trend of increasing use of patient-reported outcome measures in medical device studies the sign of shift towards value-based purchasing in Europe?. Eur J Health Econ 20, 133–140 (2019).

[5] U.S. Food and Drug Administration: Value and use of patient-reported outcomes (PROs) in assessing effects of medical devices. CDRH strategic priorities 2016–2017. https://www.fda.gov/media/109626/download. Last accessed: 15.02.2021

[6] Schlomm, T., Rödiger, T. & Graalmann, J. Präzisionsonkologie. Urologe 60, 3–7 (2021).

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Pharmacovigilance in Germany and Europe

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Pharmacovigilance in Germany and Europe

19.05.2021

Why Germany records adverse drug reaction reports

In the past, adverse drug reactions in Germany were often collected in a decentralized manner. This means that various players in the healthcare system, i.e. patients, medical professionals and authorities, reported side effects in a wide variety of ways. Today, the trend is moving in a different direction – reporting is increasingly centralized and Europe-wide, which is significantly more efficient.

For this reason, the German Pharmaceutical Industry Association (BPI) predicted in 2016 that the number of reportable adverse drug reactions would increase to 500,000 per year.[1] In this context, reports from all parties are collected and processed centrally by the European Medicines Agency (EMA).

In fact, the recording and monitoring of side effects still makes an essential contribution to drug safety even after marketing authorization.[2] Some, very rare side effects, for example, only come to light through monitoring of the broad masses. In addition, a more efficient and accurate benefit-risk analysis can be carried out in this way.

What is the legal basis for the monitoring of medical products?

In Germany, pharmaceutical manufacturers with approved drugs are required by Section 63b of the German Medicines Act (AMG) to set up a pharmacovigilance system, i.e. a system for the systematic monitoring of their drugs.

Physicians and pharmacists are also required to report adverse drug reactions to the respective drug commission when they become aware of them. Patients can also submit drug reports, but are not required to do so, even in the case of unexpected serious side effects.

Patients are the most powerful source of information and are actually best suited to fill the pharmacovigilance systems of pharmaceutical manufacturers with valuable data.

What ways are there to report adverse drug reactions?

Fig. 1 Current reporting system in Europe

    A look at the existing reporting system in Germany shows the variety of possibilities that can be very confusing for patients and reporters: Physicians and pharmacists are supposed to report ADRs to their respective drug commissions. For physicians, the Drug Commission of the German Medical Association (Arzneimittelkommission der Deutschen Ärzteschaft, short AkdÄ) is responsible; for pharmacists, the Drug Commission of German Pharmacists (Arzneimittelkommission der Deutschen Apotheker, AMK) is responsible.

    These two drug commissions then collectively forward the reports to the higher federal authorities, i.e. the Paul-Ehrlich-Institut, PEI for short, and the Federal Institute for Drugs and Medical Devices, BfArM for short. From there, complete reports are forwarded to the EMA’s European pharmacovigilance system, called EudraVigilance.

    However, it has become established that physicians and pharmacists report side effects directly to the pharmaceutical manufacturers from time to time. This is because reports are often accompanied by medical questions or product complaints.

    In addition to these reports, pharmaceutical manufacturers also receive reports from patients themselves and forward them to the EMA via their pharmacovigilance system. There, the reports are in turn entered into EudraVigilance.

    As you can see in the diagram, patients can report to all institutions themselves, i.e. to pharmaceutical manufacturers, to physicians and pharmacists, and to the higher federal authorities. With these diverse reporting chains, which are often confusing for the user, it is not difficult to assume that duplicate reports or even the disappearance of individual reports can occur.

    In addition, the submission of a report is not necessarily clearly structured for the average citizen. For a report to be considered complete, it must fully meet four criteria:[3]

        1. One or more suspected side effect(s).
        2. One or more suspect substance(s) or medical product(s).
        3. One or more uniquely identifiable patient(s).
        4. One or more clearly identifiable reporting source(s).

    Why XO Life collects patient data on adverse events

    While digitalization in the healthcare sector increasingly demands multilateral communication at eye level, comprehensive access to health information, as well as trust and security, we have made it our mission to support this development. 

    To this end, we have established a multidirectional communication platform that patients can use to report adverse drug reactions quickly, easily and in a structured manner. The reports are passed on to the respective marketing authorization holder pseudonymously, i.e. without revealing the personal identity of the reporter. Manufacturers, for their part, can send digital follow-up questions to patients with just a few clicks, which they can answer directly on their smartphones or laptops.

    What are the benefits of XO Life’s platform?

    Our platform has been shown to result in a 10-fold increase in the rate of patient feedback. Total reports can usually be closed after 72 hours, which is a significant time improvement to the current system. A look at the current number of drug reports shows that of slightly over 60.000 reports received in 2020[4], nearly 30% were processed through XO Life’s platform. However, the number of total drug reports has been declining; for example, in 2018, there were still approximately 80.000 reports.[5] This is certainly due to declining physician visits in the COVID-19 pandemic. Medical professionals recorded about 15% fewer reports during this period. 

    However, it is interesting to note that direct patient reports increased by 36% during the same period.[4;5] This clearly underlines the trend of so-called patient empowerment. Patients are increasingly taking their health concerns into their own hands. To this end, patients are using digital, user-centric tools for direct communication between patients and pharmaceutical manufacturers. XO Life’s communications platform is a typical example of such a digital tool. 

    This is how we would like to shape the pharmacovigilance of the future, through digitization and automation.

     

    It is our goal to make clearly structured data sets accessible to enable pharmaceutical manufacturers to evaluate safety-critical data both quickly and efficiently. Of course, it is our highest aspiration to perform this work in compliance with all rules of the DSGVO.

    Conclusion

    Almost 100 pharmaceutical manufacturers are already registered on XO Life’s real-world evidence platform. 50% of these also use the digital enquiry option for patients – and the trend is rising sharply. This clearly shows that pharmaceutical manufacturers are very interested in a simple reporting and communication platform to get in touch with their customers.

    This not only helps general drug safety, but also makes work easier for the pharmacovigilance departments of many pharmaceutical manufacturers. XO Life helps patients and pharmaceutical companies to get in direct contact to create an all-encompassing reporting and communication platform with real-world care data.

    Sources

    [1] Bundesverband der Pharmazeutischen Industrie e. V. & Thurisch, B. (2016). Erfassung von Nebenwirkungsberichten Herausforderungen für die pharmazeutische Industrie [Vorlesungsfolien]. Bfarm.de. https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Termine-und-Veranstaltungen/dialogveranstaltungen/dialog_2016/160226/03_Folien_Thurisch.pdf?__blob=publicationFile&v=2

    [2] Kommas, E., Lex, D., Huber, M. & Paeschke, N. (2019). Verdachtsfälle melden. DAZ.online. https://www.deutsche-apotheker-zeitung.de/daz-az/2019/daz-37-2019/verdachtsfaelle-melden

    [3] European Medicines Agency. (2017). Guideline on good pharmacovigilance practices (GVP). ema.europa.eu. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf  Zuletzt aufgerufen: 19.05.2021

    [4] Bundesinstitut für Arzneimittel und Medizinprodukte. (2021). Nebenwirkungsmeldungen Sachstand BfArM. 88. Routinesitzung.

    [5] Bundesinstitut für Arzneimittel und Medizinprodukte. (2019). Nebenwirkungsmeldungen Sachstand BfArM. 84. Routinesitzung.

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    Medical Terms & Explanations 101 x Adverse Drug Reactions

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    What are Adverse Drug Reactions (ADR)?

    04.05.2021

    Definition

    As defined by the European Medicines Agency (EMA) adverse drug reactions (ADR) are noxious and unintended responses to a medicine.[1] These, colloquially called, side effects can be caused by any pharmacologically active drug, even when used as intended. 

    In contrast, side effects caused by excessive use (intended or unintended) of the drugs are referred to as toxicity.

    When drugs are prescribed by healthcare professionals, a risk-benefit assessment is required, as all drugs can theoretically cause ADRs.[2] For this reason, patients must be aware of the risks before use and must be informed accordingly.

    How can ADRs occur?

    Often, ADRs result from low selectivity of active ingredients. Selectivity generally describes how many different structures or tissues an active ingredient binds to.[3] The higher the selectivity, the fewer structures are bound that can potentially cause ADRs.

    Another resulting reason is the different patient populations. The studies (randomized controlled trials)  that drugs must undergo before they are approved for marketing often have high inclusion criteria, which excludes relevant target groups. In very old or pregnant people, for example, these drugs can then cause ADRs, which could not be found in the pre-marketing RCT-studies due to high inclusion criteria.

    Where can I find relevant information?

    Relevant information can be found in the package insert, the drug information leaflet or web platforms such as EudraVigilance or ImpactMonitor. This information on adverse drug reactions comes from the above-mentioned studies, from in-use data collection, or from spontaneous reports as a result of real-world-evidence.

    Importance of reporting ADRs.

    Doctors, pharmacists, manufacturers, and patients are thus highly encouraged to cooperate in the detection of adverse drug reactions.[4] This sustainably increases patient and drug safety. Especially in the case of new drugs or so-called orphan drugs for rare diseases, which often only have conditional marketing authorization, the reporting of adverse drug reactions is absolutely necessary if not required by law.

    And this is exactly where XO Life comes into play, because  such reports can easily and securely be recorded via XO Life’s ImpactMonitor.

    Sources:

    [1] European Medicines Agency. Adverse drug reaction. https://www.ema.europa.eu/en/glossary/adverse-drug-reaction Last accessed: 15.03.2021

    [2] Smith Marsh E. Daphne. 2018. PharmD. BC-ADM. CDE. College of Pharmacy. University of Illinois at Chicago. https://www.msdmanuals.com/de-de/heim/medikamente/unerwünschte-arzneimittelwirkungen/das-nutzen-risiko-verhältnis-von-medikamenten Last accessed: 15.03.2021

    [3]Urban JD et al. Functional selectivity and classical concepts of quantitative pharmacology. J Pharmacol Exp Ther. 2007. 320(1) p. 1-13.

    [4] Barry, A. R., Koshman, S. L., & Pearson, G. J. (2014). Adverse drug reactions: The importance of maintaining pharmacovigilance. Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC, 147(4), 233–238. misunderstanding randomized controlled trials. Vol 210. p.  2-21. 

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    Topics of medical change: Precision Medicine

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    Topics of medical change: Precision Medicine

    23.02.2021

    Individualized therapy, through more complex drugs with multiple side effects, in different patient groups. Pharmaceutical manufacturers are developing new, increasingly precise drugs at a rapid pace – and doctors need to know their patients better and better in order to prescribe the best possible therapies. The keyword is precision medicine and, as a component of medical change, it raises many new questions.

    One of them revolves around the level of available evidence for new drugs. Through the consistent use of randomized controlled trials (RCTs), the level of evidence, that is, the predictive accuracy of individual drugs, remains at one level. This is despite the fact that evidence is one of the most important decision-making tools doctors use to determine the right therapy. It doesn’t add up! Precise and reliable evidence is needed to enable regular medicine to develop into precision medicine.

    In order to be able to treat more precisely, the level of evidence must be increased to improve the predictive accuracy of therapy efficacy and safety.[1] An alteration of the available evidence to keep up with the medical progress of precision medicine thus seems inevitable.

    What is Precision Medicine?

    The Institute of Precision Medicine (IPM) defines precision medicine as a novel medical approach according to which medical therapies are to be individually adapted to patients. Therefore, special consideration is to be given to certain factors such as the patient’s genetic makeup as well as to the patient’s life circumstances.[2]

    In order to be able to carry out such individualized therapies, the knowledge of the treating physicians about the causalities of the drugs used, which is the exact cause as well as the physiological reaction to the (side-)effect, plays a central role.

    The feasibility of such medical approaches is already given today – but due to the large amounts of data required, usually hardly possible to implement systematically. The required level of evidence is just very high and mostly not attainable. Precision medicine thus goes hand in hand with extensive data collection and is part of the hotly debated field of big data.[3]

    Precision Medicine, RCTs and side effects

    Drugs newly developed for precision medicine, like all other drugs, must prove their efficacy and effectiveness prior to market approval. For this purpose, the “gold standard,” i.e. a randomized controlled trial (RCT), is usually conducted because it is supposedly able to derive causalities compared to other study designs.[4] In the course of RCTs, correlations, i.e. dependencies between intake of the drug and effect, can be calculated. This step ultimately provides the first indications of whether a drug works as expected or not. However, these RCTs often have high inclusion criteria, so that new drugs are usually tested on people who do not correspond 100% to the patients that are going to be treated later. For this reason, the responder behavior, i.e. the (side-)effects of the drug on the study participant, sometimes differs greatly from the real patient. 

    Another problem of RCTs is randomization, which is the decision that is made by chance (randomization) which study participant receives the drug and which participant receives a placebo. Causality suffers from randomization because any prior knowledge, e.g. about responder behavior, must be ignored for the purpose of randomization.[1] This can lead to bias in the results. Nevertheless, among all available study designs, RCTs are the ones that can provide any evidence at all on causality.[5] Thus, the argument of diminished causality due to randomization is given but not necessarily relevant.

    On the basis of the evidence obtained in this way, physicians later decide which patient receives which drug. Studies have shown that the predictive accuracy (level of evidence) of the ten most prescribed drugs is only between 5 and 33%.[1] In that perspective, it would be equivalent to a one-size-fits-most approach, which has little to do with precision medicine.[1] 

    So, to make precision medicine truly marketable and ubiquitously available, the level of evidence must be improved and thus the predictive accuracy.

    What’s the role of Real-World-Evidence?

    Real cases, from real patients, with real conditions need to be observed – at best in real care. This is possible through Real-World-Evidence (RWE) generated by observation of real cases. Respectively, RWE would have to be incorporated into clinical trials in the future to consolidate evidence. Thus predictive accuracy would increase enormously, paving the way for precision medicine.

    According to Deutsches Ärzteblatt, reliable agreements on when and how RWE will be used in pivotal trials would have several advantages:[1]

    • Drug development time would be shortened
    • Study costs would decrease
    • Predictive accuracy would increase
    • A more precise description of target groups would be possible

    Physicians would have more clarity about the most promising treatment in each case and could prescribe these therapies in a targeted manner. Thus, due to the greatly improved evidence, a higher degree of effectiveness of the therapies would be achieved. Put simply, there would be more health for every euro invested.[1]

    XO Life’s contribution

    In order for every patient to receive the optimal, individually tailored medical care in the future, and thus a change to precision medicine can take place, the use of RWE, is enormously important. This requires a system that can capture and process all the information needed from real-world care.

    XO Life has developed the ImpactMonitor for this purpose, which, in addition to general medically relevant information, can also be used to collect and evaluate individual information directly from the patient (PROMs). This promises a condensation of evidence and thus a higher degree of evidence as well as a higher prediction accuracy. Physicians can rely on more precise evidence and patients receive individually adapted therapies. A cycle that continues and ultimately makes medicine more and more precise and individualized.

    Sources:

    [1] Dtsch Arztebl 2019; 116 (39): A 1708–12. https://www.aerzteblatt.de/archiv/210058/Klinische-Studien-Genauere-Evidenz-fuer-Praezisionsmedizin-notwendig  Last accessed: 23.02.2021

    [2] Institute for Precision Medicine. Definition of Precision Medicine. http://ipm.pitt.edu/definition-precision-medicine Last accessed: 23.02.2021

    [3]Dtsch Arztebl 2020; 117(22-23): A-1184 / B-1000 https://www.baek.de/praezisionsmedizin2020 Last accessed: 23.02.2021

    [4] Cartwright N, Deaton A. 2018. Social Science & Medicine. Understanding and misunderstanding randomized controlled trials. Vol 210. p  2-21. 

    [5] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. 2020. Allgemeine Methoden. Vol 6.  p 10. 

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    XO Life is shaping the future of drug safety.

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    XO Life is shaping the future of drug safety.

    01.01.2021

    From nebenwirkungen.de to the leading drug safety reporting platform – how we are equipping evidence-based medicine through patient insights for the future of precision medicine. What is the role of ImpactMonitor and how are we influencing digital health as well as the precision medicine of tomorrow? 

    What benchmarks are we setting through technologization and digitization of reporting pathways?

    Real-world evidence platform for drug efficacy and drug safety.

    XO Life aims to create the leading reporting platform for generating Real-World Evidence (RWE) for drug efficacy and drug safety. To reach that goal in the near future we have created an innovative, multi-directional communication platform that unites consumers, physicians, pharmacists and manufacturers. This allows the systematic sharing of relevant information on drug efficacy and safety in the real world. 

    The data we collect is made available in a standardized and structured way to various healthcare stakeholders, such as doctors and pharmacists. The goal is to provide a larger database, based on real-world care settings, for increasingly personalized drug prescriptions. Especially in the case of new pharmaceuticals with conditional market approval, the application-accompanying data collection upon marketing authorization is indispensable. 

    Therefore benefit and tolerability can be monitored in real time and further evidence can be generated.

    XO Life – the leading drug safety reporting platform

    After nearly 2 years of development, we are the leading reporting platform for patient adverse events. Our new reporting tool sets the standard for direct, digital and time-saving communication, between all parties involved in the reporting process. 

    With a market share of currently approx. 30% of all spontaneous reports, more than 2000 patients entrust us with their drug experiences every month. In accordance with international pharmacovigilance guidelines, we forward these pseudonymous reports, i.e. without disclosing the personal identity, to the responsible manufacturers for further processing. Our collected reports are currently already being processed by over 400 manufacturers. More than 70 of these are registered with us for further functions. 

    This is where the great advantages of our reporting platform become apparent, because more than 30% of the collected reports receive queries from the manufacturers. Also, the feedback rate from patients is around 60%. Due to the simplicity and automation of digital communication, cases are closed after 72 hours at the latest. 

    In accordance with legal requirements, the manufacturers then forward the reports to the European Medicines Agency. This is followed by an evaluation by the risk committee. 

    Our innovative communication platform is seamlessly integrated into the existing legal monitoring system for drug safety throughout the entire process. We place particular emphasis on the redesign of pharmacovigilance, in terms of digitalization and user orientation. This is another reason why we offer our platform technology as a software-as-a-service solution. Pharmaceutical companies can thus use internal, proprietary reporting channels, e.g. their website, social media channels, input by field staff or call centres. 

    Up to 95% time savings are possible by digitizing and automating pharmacovigilance processes.

    Expansion of the platform to include additional drug efficacy recording.

    Our platform technology and partner network have now reached a level of maturity where we are evolving from a reporting platform for side effects to a real-world evidence platform. In addition to the recording of side effects, the focus is now also on the monitoring of the efficacy of drug therapies. In collaboration with leading researchers, we are applying standardized measurement tools for recording Patient Reported Outcomes (PRO). Our web platform aims at collecting thousands of consumer experiences in a structured way in order to create personalized risk-benefit profiles to support drug prescription. Additionally, clues for novel therapies and drug development are released. The findings can be further used for comparison with those from clinical trials. 

    The possibilities going to be offered by our RWE platform are limitless: e.g. we enable the integration of telemedicine services to consult with medical experts. In addition, simple and secure communication channels can become available between manufacturers and consumers to answer medical inquiries. Safety-relevant information can also be requested via this channel. 

    Our web application can be used flexibly, among other things as a white label solution, for manufacturers’ own product launches, such as new active ingredient approvals in the population. 

    With the so-called ImpactMonitor patients can digitally record their therapy progress with regard to efficacy and side effects. For this purpose, patient-specific characteristics such as age, gender, state of health, medications, concomitant diseases and data relevant to everyday life on quality of life are collected. The ImpactMonitor is characterized by a quickly available, structured data. In addition, it offers many new possibilities for health technology assessment. 

    Compared to the data collection of the past, the ImpactMonitor collects high-quality data in a very short time and at a much lower cost.

    XO Life shapes the future of drug safety 4.0

    After our market entry with nebenwirkungen.de, it is now time to fully realize our vision of a reporting platform for drug efficacy and safety. Data security, data quality and the protection of consumers’ personal data are particularly important to us. Real-time data transfer, user-friendliness and customizable software solutions are our tools to establish real-world evidence for the efficacy and safety of drug therapies. 

    Our goal is to ensure that every patient receives the best available drug therapy at any given time.

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