Clinical Research Insider Summit No. 11

The Future of Clinical Research: Realities, Solutions, and Expectations

Undoubtedly, the future of clinical research came to all of us earlier than expected due to the pandemic we have been experiencing globally since 2020. There was talk about the digital age and remote visits, but as of March 2020 life changed, without warning or preparation on our part.

Patients could not go to research sites from one day to the next, which forced us to adapt to the new circumstances, look for plan B to help research protocols survive, and avoid as many deviations as possible to have valid data, while still taking care of patient safety.

What is the future of clinical research? The first logical answer would be to say that its advancement through technology, which is a fundamental part, but we have to understand that technology does not define us. On the contrary, this should be one more tool in our kit to be able to give a solution to the enormous continuous and “live” challenges that are presented day by day in a clinical research site, to the CRA responsible for monitoring the study, to the data analysts, to the local and international authorities, as well as to those responsible for pharmacovigilance and to the patients themselves.

Is there a perfect formula? No, it all depends on how we adapt, and how we individualize each study depending on the complexity, indication, number of patients, number of visits, and enrollment times. With all this data we must establish risks, as well as preventive and corrective plans applied as quickly as possible, with the key being MonitorSite-Patient communication.

It is essential to define what we can be flexible about and what we must correct at the same time, what we cannot be flexible about and when we must pursue compliance.

Miriam Marquez

Director of Centralized Monitoring at PPD, part of Thermo Fisher Scientific.