FDA promotes enrollment practices that should lead to clinical trials better reflecting the population most likely to use the drug, if approved, and as such issued the Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry | FDA guidance. Despite this effort, challenges to participation in clinical trials remain, in addition to the very low efficiency rate of clinical trials: with an average efficiency rate of 11%, clinical trials constitute one of the least efficient industries, and only 1 in 10 drugs passing the strategic step of first in human get to market.
Increasing access to & efficiency of clinical trials must happen – to lead to a reduction of patient burden. As confirmed by patients themselves, one of the main barriers to joining a clinical trial is the logistical burden of following the study protocol procedures. Reducing these barriers is paramount to improving enrollment and retaining patients in the trial. David, multiple sclerosis patient, UK, acknowledged:
“In multiple sclerosis, where you have a severely progressive disease, you might not even want to volunteer for a clinical trial, because of the travel and logistics burden. Digitalization of the research will allow recruitment of more severely [ill] patients or [those] living in remote areas”.
Decentralizing clinical trials means bringing the study to the patient’s environment instead of asking the patient to attend the study center; as such, it is expected that it will significantly decrease the logistical barrier and make clinical trials more practical for participants.