The modern headaches of clinical trial design
You’re probably familiar with the obstacles that hinder successful clinical trials. Many of today's challenges relate to patient recruitment. Finding the right patients in the right places, enrolling those patients, hitting recruitment goals, keeping patients engaged — the list goes on. As a result, 80% of clinical trials fail to meet their participant enrollment rate targets.
And with the shift towards more targeted treatments, clinical trial recruitment is getting even more challenging. Eligibility criteria are more complicated and stringent than ever before.
So, what happens when there are fewer patients eligible for your study than expected? There can be very costly consequences: protocol amendments, delayed milestones or even the premature discontinuation of the clinical trial. No matter the form, you’ve wasted time, money and resources.
In theory, one smart way to avoid recruitment challenges is to assess clinical trial feasibility further upstream, while the research protocol is still being designed. But protocol design and feasibility assessment are often siloed. So, by the time feasibility teams are involved, the protocol is already finalized. Bridging that gap is easier said than done. It requires not only the right tools and data to understand how protocol designs affect feasibility, but also the right forms of team collaboration.
New frontiers in clinical trial design, feasibility and protocol
Clinical trials have incredibly high stakes. And, given the high standards of regulatory bodies around the world, scientific rigor is paramount to their success. But there’s a balancing act at play across multiple priorities here. You want to maintain that scientific rigor while creating and running a trial designed to answer as many questions as possible.
That balance between protocol design and feasibility is crucial in order to have a study that is both scientifically sound and viable, meaning you can actually find and enroll patients who fit the clinical study criteria.
Keep in mind, this is a new era with real-world clinical data. You don’t have to rely on historical data from past clinical trials to conduct feasibility anymore — you can look at real-time electronic health record (EHR) data from health care facilities across the country.
This evolution helps make the case for assessing feasibility before the trial protocol is finalized. When you can analyze granular patient characteristics important to your study from millions of real-time patient records, you can optimize your protocol upfront to simplify recruitment efforts and preserve downstream resources.