Real world data, made possible by digitalization, must be infused into clinical research to lower failure rates and improve overall care. Contract research organizations (CROs) should be at the forefront of building the bridges connecting clinical research and clinical care.
Freimut Schliess earned his doctorate in Chemistry and taught and researched in German universities for a couple of decades. Now for over a decade, he has been with mid-market, full-service CRO Profil GmbH. Recently he wrote about how CROs are in an ideal position to bridge the divide between clinical research and care. TrialSite News breaks down his position in a few Question & Answer segments.
Why is the topic of real-world data so relevant today as in Dr. Schliess’ article?
Because we are in the midst of a transformational period in clinical research and care options fundamentally driven by Digitalization. A fundamental key to this point of view, Digitalization is a mega-trend impacting nearly all facets of life and work. In healthcare, the sensor-based acquisition of health & behavioral data and the derivation of digital biomarkers as by pattern recognition and artificial intelligence tools is expected to revolutionize clinical research and clinical care.
How will Digitalization Impact Research and Care?
Health care solutions being delivered on the market will increasingly be influenced—shaped—by the exploitation of continuously person-generated health and behavioral data that changes the game in health outcomes. It offers a continuous stream of valuable information about what a patient is doing; what are they taking; how are they behaving. Presently we see the technology disruptions, process changes and policy support that will ultimately lead toward ubiquitous data fed research and care augmentation services and products that will contribute to improving outcomes.
What is the problem with clinical drug development today? What happens if all participants in the value chain don’t embrace the changes?
In most cases, we presently experience a lack of data problem—that is, limited availability and usability of person-generated real-world data.
This lack of real-world data adversely impacts clinical drug development by diminishing the predictive value of controlled clinical trials. For example, Dr. Schliess notes that it is this lack of continuous real-world data that materially contributes to high attrition rates as measured by 50% failure rates for drug candidates even in Phase III!
Or looked at from another vantage, from the 1950s to 2013 450 drugs forced to be withdrawn from the global markets.
In clinical care, the lack of real-world data usage adds to the gap between the efficacy of investigational drugs and devices in well-controlled clinical trials and the effectiveness of products in real-life.
How Can CROs Add Value in the Rapidly Evolving Clinical Research to Care Transformation?
Dr. Schliess believes that CROs’ should play an instrumental part in the transition to real-time, real-world inspired health care from research to care. He argues this is the case for CROs for the following reasons:
- They have developed specialized knowledge and experience supporting industry sponsors in their quest to implement digital solutions into various therapeutic care initiatives—such as diabetes initiatives mentioned in the article.
- CROs are driven by their growth performance mandates in the context of hyper-competitive global markets, and this fuels an ambition that coupled with specific industry knowledge and relationships in the context of real-world data initiatives positions them to enter into collaborative innovation ecosystems thus allowing them to tap into and access even more knowledge, insight and talent to further accelerate their specializations in key digitization initiatives
- New real-world support service bundles: Emerging real-world data acquisition services include consultancy around the scientific, regulatory and legal implications of real-world data acquisition and exploitation to services helping the sponsor to actually design real-world data inspired clinical trials to the corresponding enrichment of the data management and statistics to plan to the selection and validation of appropriate sensor system, the education of trial participants and the operational implementation of real-world data acquisition including a remote monitoring of trial participants.
Dr. Schliess obviously wrote the piece representing his firm, Profil GmbH which has its own business agenda. He has been around long enough to see the trends that he writes about to unfold—in real time—in very real ways in the drug development markets.
CROs will absolutely play vital roles in not only inspiring but actually in some cases designing and implementing real-world data-driven clinical research that will have over time profound influences on clinical care. As always follow the link below for the source article.