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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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