Patient Participation

To ensure that everyone involved recruiting pediatric subjects is on the same page, maybe it's time to go to the videotape.

A skillful mix of marketing and management savvy together with scientific expertise makes a recruitment campaign sing.

A standardized subject retention and adherence system helps study staff focus on critical details during all phases of a large, simple trial.

I've recently reviewed many articles on subject recruitment, retention, and attrition in clinical trials. I have found the same three basic research methods: surveys (by telephone and in person), interviews, and focus groups. The information gathered from the three methods include demographics, willingness to participate, problems experienced in clinical trials, motivations for volunteering, health behaviors, social support, benefit expectations, and understanding of the research project. But such strategies collect only the most superficial data, so we don't know nearly as much about the clinical trial experience as we need to know.

IRBs often set an arbitrary grade-level requirement?such as sixth or eighth grade?at which consent forms are supposed to be written...

Study findings identify various factors affecting subject enrollment in today?s clinical trial world.

Pediatric trials got a good report card from a survey that explored the motivators and experiences of young subjects and their parents.

One of my articles, published in 2000, opened with this statement: "In some ways, clinical drug research is a service that research participants can choose to buy-or not buy. Some participants (consumers) may benefit from buying a product (a new drug); many researchers (salespeople) will be paid for each subject they recruit."1

Kenneth Getz and Deborah Borfitz, CenterWatch (Boston, MA, 2002) 306 pp., $16.95.