Research suggests higher participation burden increasing trial dropouts

Most people who drop out of clinical trials do so by choice rather than due to adverse reactions to candidate drugs, according to new research, which suggests the burden of taking part in studies has increased markedly in recent years.

Researchers at the Tufts Center for the Study of Drug Development (CSDD) announced their findings this month, arguing that growing study complexity and burdensome procedures put people off from taking part in trials.

“The participation burden for patients in clinical trials is rising, especially in non-oncology studies,” the authors wrote, adding, “More than half of study dropouts are the result of patient choice, not due to adverse drug reaction or a decision by the investigator or study staff.”

The analysis revealed that participation burden in Phase II and III protocols increased 39% since 2019 due to the high number of questionnaires, requirements for lab and blood work, and the frequency of procedures.

Additionally, while the authors suggest that core procedures, such as those required by the study protocol, account for 53% of participation burden, the number of noncore procedures conducted in an average trial is increasing.

They also pointed to increased trial site visit requirements as a contributor that is putting people off, explaining that “over 45% of Phase II and III protocols have average visit durations of more than two hours, compared to 17% a decade ago.

How this trend can be addressed and trials made less burdensome is unclear; however, according to the Tufts team, such efforts are worth taking for patients, sponsors, and CROs.

“Less burdensome protocols in Phase II and III clinical trials are associated with lower patient dropout rates, shorter trial durations, and fewer protocol amendments and deviations.”

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