3 innovative Möglichkeiten, um Real World Evidence zu generieren

Real World Evidence, also aus Real World Data gewonnene Erkenntnisse, ist für die pharmazeutische Industrie ein Booster für die Entwicklung, Zulassung und Vermarktung ihrer Produkte. Dafür stehen ihnen heute bessere Datenquellen denn je zur Verfügung. 3 innovative Möglichkeiten stellen wir in diesem Beitrag vor.

The term Real World Data (RWD) is associated with a great hope for the pharmaceutical industry: large amounts of health data that give research access to new knowledge about diseases and drugs - and develop an innovative power for the entire healthcare system. The magic word here is: Real World Evidence (RWE) - in other words, scientific findings obtained from real-world data.

Real World Data: What's behind it?

Real world data is health data that is collected from patients in their everyday lives. This can be data collected via electronic patient records (e-health records) or digital measuring devices and applications, for example. The advantage of RWD is that it reflects the health and behaviour of people in their natural environment. Compared to data collected as part of clinical studies under highly controlled conditions, RWD is therefore a much better reflection of a patient's reality in everyday care.

At the same time, RWD is high quality data that gives researchers a more accurate picture of how drugs work in different patient groups. With the help of the data obtained from RWD Findings on the effect, adherence and efficacy of medication in the real care situation (Real World Evidence) lassen sich Therapien viel besser auf einzelne Patient:innen zuschneiden. RWD sind deshalb einer der Hoffnungsträger auf dem Weg hin zu einer personalisierten Medizin, die den einzelnen Patienten ins Zentrum setzt.

Die Realität der klinischen Forschung ist gegenwärtig noch ein gutes Stück davon entfernt, das Potenzial von RWD auszuschöpfen. Denn um Real World Evidence zu generieren, braucht es Structured, high-quality data in digital form. However, paper and laboriously created Excel spreadsheets are still frequently used as data carriers in research projects. Yet there are simple digital methods for continuously, conveniently and efficiently recording valuable real-world data in patients' everyday lives.

RWE generieren: Diese 3 Möglichkeiten sollten Sie kennen

1.

Remote Patient Monitoring (RPM)

Telemonitoring Grafik

A continuous course of central vital signs (e.g. heart or lung function) is a decisive factor in evaluating the success of a therapy. It shows how a patient's state of health develops over time - e.g. as a result of taking a medication. However, regular visits as part of a clinical trial are a time-consuming process that limits the number of measurement points and therefore only provides selective snapshots of the overall picture. However, if the subjects record their values themselves and enter them in forms, the data density often suffers from suboptimal measurement adherence.

Remote patient monitoring (e.g. with our RPM platform SaniQ) is able to do this, RWD with very high data density and the highest data quality in real time to generate. With RPM, patients are medically monitored outside the clinical facility using digital technology. Thanks to daily measurement points, researchers receive a consistent picture that provides valuable insights into the effect of a drug. Measurement and medication adherence can also be positively influenced with RPM, for example by using a patient app to remind the test subjects of due measurements or intake.

2.

Sensor technology: wearables & co.

The use of wearables (e.g. smartwatches) or other electronic sensor devices (e.g. blood pressure monitors, spirometers, etc.) is an efficient way to generate RWD. The sensor devices record health parameters such as pulse, heart rate or activity level and transmit them to a smartphone app or web-based software.

The advantage is obvious: the sensor devices generate continuous RWD in real time, which enables researchers to complete data record over a longer period of time to collect data. This allows events and fluctuations that might go unnoticed during sporadic visits to be recorded and analysed. In conjunction with remote patient monitoring, wearables & co. therefore stand for modern, digital recording of high-quality real-time data. 

With our adaptable SaniQ platform, you can monitor more than 15 vital signs using a wide range of sensor devices:

Infografik SaniQ Vitalwerte

3.

Electronic questionnaires (PREMs & PROMs)

The subjective experiences of patients with a therapy are among the most relevant real-world data. It provides pharmaceutical manufacturers with important information about the safety of a drug and adherence. When generating such data, however, pharmaceutical companies repeatedly encounter difficulties when it comes to reaching patients for regular surveys. In addition, questionnaires on paper are still frequently used to conduct such surveys, which then have to be laboriously transferred to a database.

Electronic questionnaires such as PREMs (Patient Reported Experience Measures) and PROMs (Patient Reported Outcomes Measures) offer a smart solution here by collecting patient feedback in a user-friendly digital way. Via the patient app of our RPM platform SaniQ For example, patients receive a notification as soon as a new questionnaire needs to be completed. This reminder function automatically prompts patients to fill out the questionnaire and eliminates the time-consuming process of transferring paper to the database.

Conclusion

Real World Evidence hat ein großes Potenzial für die medizinische Forschung und Praxis. Pharmahersteller können sie nutzen, um bessere Wirkstoffe zu entwickeln, klinische Studien und regulatorische Prozesse zu beschleunigen und die Therapie im Sinne einer personalisierten Medizin besser auf den einzelnen Patienten zuzuschneiden. Digitale Lösungen wie unsere RPM-Plattform SaniQ eröffnen Forschenden im Pharmabereich dabei neue Möglichkeiten, um RWE effizient und patientenfreundlich zu generieren.

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Jonas Zimmer
-Project development-

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