No one denies that realm of everyday work in clinical trials is somehow broken.
Information overload in clinical trials burdens even the most experienced study teams. But no existing strategy to revolutionize clinical trials seems to make sense.
Only constant and incremental improvements that benefit from technological advancements and the collective wisdom of all stakeholders will create change. We have more than 15 years of experience, both from a Principal Investigator perspective as well as from being Clinical Research Associate on the other side. We’ve gained many insights and deeply understand all the pains that sites have to face making trials the real thing. That’s why we have taken a site-centricity perspective: to change completely how the clinical sites working model might look.
In the near future, we imagine that conducting clinical trials will not only be a privilege for a few highly-specialized but very hermetic organizations. The new model should lean towards distributed and agile networks of experienced clinical centers, and collaborating physicians from their surroundings. For sure you can find very good examples of such collaboration even today, but our ambition is to make it something normal and universal. Everywhere.
We also need to think about quality and the models of communication between a site team and the study team, especially study monitors.Why not try to take a different approach, using on-hand benchmarks and modern technologies that we have recently become accustomed to? Think about the concept of the "smart site” as an agile and efficient organization that is doing tasks with less effort but at the same time focusing on what really matters and quickly eliminating trial backlogs. As a result, we become more productive and avoid wasting the time and resources of the site team. And of course, we will be loved by sponsors because it means better performance and higher quality.
Dawid Wiener, MD PhD
is a physician with a PhD in philosophy and research focus on cognitive science. Former head of strategy in an advertising agency, director of research&development in a market research agency. Worked as a Clinical Research Associate and co-founded the innovative agency Cogision, primarily engaged in research in the field of design, usability, and Ux which also launched an advanced SaaS solution called UsabilityTools usabilitytools.com
Przemysław Bogacki, MD
is a medical doctor (psychiatrist), with 20 years of experience. Founder of an outpatient clinic and research center. Principal investigator in over 50 clinical trials in psychiatry, and as head of the clinic in other indications. National coordinator of several clinical research projects. MedAvante expert-clinician remotely performed live interviews with subjects at investigative sites for clinical trials.