Clinical Research Network (CRN) update #6: meeting recruitment goals in clinical research--lessons learned (Part one).

An estimated 80% of all clinical trials fail to meet recruitment goals (Marks RG, Conlon M, Ruberg SJ. Paradigm shifts in clinical trials enabled by information technology. Stats Med. 2001;20:2683-2696). The CRN, despite this statistic, was very successful in meeting its overall recruitment target. To achieve this goal, common recruitment strategies across the 4 trials were developed. These strategies included:

* Maintaining a physical presence in referring clinics

* Providing a full explanation of the trial and being thorough with the participant from the beginning

* Following up with the participants with frequent phone calls

* Allowing flexibility within the constraints of the trial.

Within this framework, however, each study developed a variety of unique recruitment strategies specific to their individual studies. The next 4 CRN updates will highlight the innovative steps taken by each study. The first study to be featured is PEDALS.

Pediatric Endurance Development and Limb Strengthening (PEDALS) is evaluating whether a 12-week program of stationary cycling can enhance function in children with cerebral palsy (CP). The recruitment goal of 60 was exceeded by 4 for a total of 64 participants.

The unique recruitment steps taken were:

(1) Establishing intervention sites in the childrens' community. This:

* minimized the amount of travel required for the intervention

* allowed the children to attend "after school" intervention sessions

* garnered support for project recruitment through project-related training for intervention therapists (physical therapists). This established an academic-clinical partnership for client referrals.

(2) Posting recruitment flyers in the primary cerebral palsy medical treatment clinics for each state or region and asking that awareness of the project to be passed by "word of mouth."

(3) Participating in on-going in-service education programs for agencies that provide physical and occupational therapy services for children with CE The content was the "importance of physical fitness for children with CP." The study was included as part of the presentation, which concluded with recruitment information for those interested.

(4) Using client incentives proved helpful and were especially important for the control (no exercise) group that did not receive (no-fee) physical therapy. As an incentive, all participants received a free overground bicycle adapted for their special needs, if necessary, and a free bicycle helmet.