Accrual Patterns for Clinical Studies Involving Quantitative Imaging: Results of an NCI Quantitative Imaging Network (QIN) Survey

Abstract

Patient accrual is essential for the success of oncology clinical trials. Recruitment for trials involving the development of quantitative imaging biomarkers may face different challenges than treatment trials. This study surveyed investigators and study personnel for evaluating accrual performance and perceived barriers to accrual and for soliciting solutions to these accrual challenges that are specific to quantitative imaging-based trials. Responses for 25 prospective studies were received from 12 sites. The median percent annual accrual attained was 94.5% (range, 3%–350%). The most commonly selected barrier to recruitment (n = 11/25, 44%) was that “patients decline participation,” followed by “too few eligible patients” (n = 10/25, 40%). In a forced choice for the single greatest recruitment challenge, “too few eligible patients” was the most common response (n = 8/25, 32%). Quantitative analysis and qualitative responses suggested that interactions among institutional, physician, and patient factors contributed to accrual success and challenges. Multidisciplinary collaboration in trial design and execution is essential to accrual success, with attention paid to ensuring and communicating potential trial benefits to enrolled and future patients.

Clinical Trial Design and Development Work Group Within the Quantitative Imaging Network

“…With additional procedures and administration of imaging agents, trials involving the development of new QI methods/tools may face more challenges in patient recruitment. The CTDDWG surveyed 25 prospective clinical studies from 12 sites to evaluate the accrual performance, barriers, and solutions that are specific to QI-based trials (6). Our findings showed that the median percent annual accrual attained was 94.5% (range, 3%-350%).…”