Atul Mahableshwarkar, M.D., DFAPA, joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss clinical trial methodology. A self-described “trial nerd,” Atul illuminates the make-or-break role methodology plays in a trial’s success and shares his advice and best practices for making positive outcomes possible.
Dr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes.
Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years.
- The pivotal role of strong methodology in allowing good products to succeed
- Atul’s advice for others beginning to design clinical trials
- What he sees as the greatest challenges clinical trials have in common
- How teams can help motivate clinical trial participation
- Where standard concepts of patient-centricity may be lacking
- How collaboration can help minimize mistakes
- The Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug status
- How the pandemic nearly tripled Emalex’s enrollment
- The importance of supporting sites that may feel threatened by decentralized clinical trials
- The pandemic-enforced recruitment practices he plans to continue
- Key considerations in choosing a preferred ratings scale, and what his is
- Rater training as a misnomer that needs revising
- How to assess and manage raters appropriately
- The value of monitoring data and communicating insights to stakeholders in real time