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ASH 2024 | Factors that influence clinical trial enrolment in hematological oncology

Rupayan Kundu, MD, Cleveland Clinic, Cleveland, OH, comments on the factors influencing enrollment success in hematological malignancy clinical trials. He mentions that certain factors such as study design, lead sponsor agencies, primary and secondary endpoints, and study size significantly impact enrollment success rates. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (AI-generated)

So we looked at the factors that affect the clinical trial enrollment success rate. As you know, clinical trials are a vital part of any kind of cancer research [inaudible] in any treatment options. And almost 20%-ish clinical trials fail due to basically problems with enrollment rates. And we defined the enrollment success rates as greater than 85% or more of whatever there was estimated enrollment...

So we looked at the factors that affect the clinical trial enrollment success rate. As you know, clinical trials are a vital part of any kind of cancer research [inaudible] in any treatment options. And almost 20%-ish clinical trials fail due to basically problems with enrollment rates. And we defined the enrollment success rates as greater than 85% or more of whatever there was estimated enrollment. And we found out that certain factors, for example, the activation year or study design or the lead sponsor agencies or the primary or secondary endpoints or the number of enrollments, those are the things that determine the success rates of a clinical trial. So basically we saw like we got data from clinicaltrials.gov and we almost got like 29,000 clinical trials and then we excluded those clinical trials based on the intervention… So we included those based on the intervention studies and those who had the results within May… Within December of 2023. So basically, and then we excluded those studies, we got almost, mostly like 2,000 or some more than 2,000 clinical trials. And we found out that almost, probably like the Phase III clinical trials are, that those clinical trials have the most enrollment success rates. And also regarding the sponsor agency, mostly the industry sponsor agencies, those do better than NIH or other academic institutions, mostly because of the funding, because of cutting-edge technologies. The other thing is also the primary endpoint. For example, if we see that there are more than two or three primary and secondary endpoints, those studies will have more data, and those do better on the enrollment success rates. And sometimes we do single-center studies, sometimes multi-center studies, sometimes like multinational studies. The multinational and multi-center studies probably like greater than five sites are doing better enrollment success than those who have like less than five or three sites. And lastly, those who have less than 50 patients, enrollment patients, those are doing better than studies that have greater than 50 or greater than 200 basically. And I think our study basically suggests that there are variabilities based on those factors and we can focus on those factors to basically increase our enrollment success rate.

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