Performance Improvement 2007. What Evaluation Design Would Best Measure the Success of Different Ways to Recruit Patients to Participate in National Institutes of Health Clinical Trials?



This feasibility study was the first of a multi-phase, multi-year evaluation seeking to answer the question: what patient recruitment strategies result in the greatest number of contacts, referrals and enrollments in National Institutes of Health (NIH) clinical trials for various categories of clinical studies? NIH needs several thousand new patient participants each year for clinical research it conducts. Clinical research conducted by NIH itself ("intramural" research) at the Mark O. Hatfield Clinical Center, is essential to the innovative excellence sought by NIH. At any given time, the 15 Institutes of NIH have nearly 900 clinical studies ("protocols") underway for which patient and non-patient volunteer participants are being actively recruited. While over 5,000 new participants are enrolled in these clinical trials each year from the direct efforts of NIH, several times more participants are needed. NIH clinicians do not provide regular routine care to a patient population from which they can draw clinical trial participants. They must recruit from external sources, such as referrals from other physicians. Patient recruitment is one of the most significant bottlenecks to treatment development. Failed or delayed trials extract significant costs, wasting money, patient participants' time, and discouraging care professionals from cooperating with future research. On a national basis, it has been estimated that 78 percent of all clinical studies fail to enroll the needed number of patients on time.

To facilitate its recruitment efforts, NIH established two centralized recruiting offices: the Patient Recruitment and Public Liaison (PRPL) serving investigators across institutes, and the Clinical Studies Support Center (CSSC) recruiting patients for National Cancer Institute studies. These two offices provide NIH with some centralized aid in recruiting subjects, yet personnel for individual studies often must recruit patients on an ad hoc basis, and little guidance for successful recruitment exists. These two offices are able to provide only a fraction of the total number of study participants needed. The study focused on gathering and evaluating PRPL and CSSC recruitment data to assess recruitment strategies for NIH intramural early phase clinical trials.

This study arrived at four major findings: It identified a number of key variables of interest in each data set (for PRPL and CSSC) as well as a more limited number of key variables common to both. Researchers determined that the primary definition of "success" in recruiting patients into clinical trials should be referral to a study protocol. Several basic categories of patients, diseases, and protocols were developed. Finally, researchers examined how often different recruitment strategies were used as well as the source of information reported by the patients (leading them to participate) across these categories. The goal of the overall project is to develop an evidence-based systematized approach to help both the PRPL and the CSSC and individual investigators in selecting patient recruitment strategies that will result in optimum patient enrollment in particular studies. Results of this first, feasibility, study will serve as a baseline for the development of a prospective study and of methods to collect improved recruitment outcome data.

Report Title: Evaluation of Patient Recruitment Strategies (for NIH Intramural Early Phase Clinical Trials) -- Phase 1 Feasibility Study Final Report
Agency Sponsor: NIH, National Institutes of Health
Federal Contact: Dominguez, Dinora, 301-402-6072
Performer: CSR Incorporated; Sponsored by: National Institutes of Health: Mark O. Hatfield Clinical Center and the National Cancer Institute; Arlington, VA
PIC ID: 8384

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"PerformanceImprovement2007.pdf" (pdf, 717.63Kb)

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