Current Systematic Challenges Faced by Clinical Operations Professionals

In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future trends in clinical trials. Key challenges include high costs, long timelines, lack of diversity, and rigid protocols. Das highlighted technological advancements such as AI, real-time monitoring, and historical data analysis, which are all expected to optimize trial design and patient recruitment in 2025 and beyond.

ACT: As we move into 2025, what are some of the systematic challenges clinical operations professionals are currently facing?

Das: That's a great question. I'm happy to be having this conversation with you today, Andy. First, let’s review very quickly, what are some of the systematic challenges that clinical trials are facing right now, or clinical operations executives are experiencing right now. I think first and foremost, of course, is the high costs and the long timelines required to go through a trial, and because it is time consuming and as expensive as it is, you want to ensure the likelihood of success as much as possible. With that, I think some of the key issues that are coming out first and foremost is lack of diversity as drugs become more targeted to very specific patient populations and narrower disease states, it actually increases the burden on the patient diversity represented in the trial itself, so that when that product goes to market, it can be rapidly deployed by the very diverse and large set of HCPs and providers really at a global basis. So that's the first thing that comes to mind. Next, of course, is data and methodology. There is a lot of rigid protocols that keep us safe through that trial process and ensures that what's hitting a patient is appropriate and optimized. However, the emerging nature of data, which is a lot more fluid, a lot more real time, and you want to take in more diverse data sources into account when determining appropriate use or targeting of a product, that actually does not adapt so well to the existing rigid protocols, so you definitely want to work on that. And last, but certainly not the least, is the patient-centric issues around geographical barriers to participation; patients actually understanding the trials they're about to get recruited into, adherence, and actually sticking with a trial, and, of course, again, making sure that those participants are tracked through post-trial to see how they're actually doing with those products on a medium to long term.