Conducting clinical trials for heart-related diseases in the U.S. is difficult, even though these diseases affect many people. To gather enough participants, trials often need large networks of locations both in the U.S. and internationally. If a study does not enroll enough people, it can face delays, waste resources, and take longer to complete. Because of these challenges, we examined data on trial locations and enrollment patterns in recent heart disease studies.
A survey of Phase 3 clinical trials in cardiovascular indications over 5 years found that these trials involved hundreds of sites spread across the globe to recruit the target number of patients. The US had the most number of sites, accounting for about half of all sites, but these sites recruited at about half the rate compared to the sites located in South America and Eastern Europe. The average enrollment rate was about 0.3. The US accounted for about 25% of the total number of sites in these trials and about 20% of the total number of patients, on average. The patient populations were less diverse in these trials.
Although this survey had many limitations, the findings are not surprising and common across all indications. Almost all large phase 3 clinical trials require multinational sites, only because without it, any of the trials could not be completed in a reasonable time and cost. While there has been a lot of discussion in the last few years about increasing the participation of US-based sites, the FDA even requires an increased US patient population for certain indications. However, without changes in the US recruitment rates, sponsors have no options but to go to other countries to find patients.
It has been suggested that US clinical trial recruitment can be improved through decentralized and remote trials, training more physicians in clinical trials, training research sites on recruitment strategies, improving site performance tracking, and addressing cultural barriers, but that’s easier said than done. There is a need for creative out-of-the-box and pragmatic strategies for conducting clinical trials. Doing the same and expecting different results is a fool’s errand.
