Patients Front And Center: Involving The Patient In Clinical Trial Design

Recruiting patients for clinical trials poses challenges. A review of 388 clinical trials spanning from 1997 to 2020 discovered that only 63% of trials achieved their final recruitment goals, with 32% requiring an extension to meet these targets. Approximately 22% of trials reached within 80% of their final goals, with 36% of them necessitating an extension for recruitment. Notably, 30% of the trials revised their original recruitment goals, with 67% opting for a downward revision.

These statistics underscore the industry's ongoing quest to enhance patient recruitment for clinical trials. However, certain barriers remain formidable, such as geographical distance from trial sites or patients' unique medical needs and life circumstances.

Harnessing the insights of patients with valuable lived experiences holds promise for improving clinical trial design, yet this integration is a work in progress. Although, the benefits of such efforts are undeniable. A study evaluating the financial value of patient engagement in clinical trials reveals that a patient engagement initiative, which averts a single protocol amendment and enhances enrollment, adherence, and retention, can increase the expected net present value (ENPV) by $35 million pre-phase II and $75 million pre-phase III.

Access the full article below to learn how to create more patient-centered clinical trials, ultimately benefiting both patients and the research community.