Patient Participation

As patient centricity continues to evolve, the differences in perspective between sponsors and the FDA over how to define this concept run parallel. With rising awareness will come the need for a definitive model that incorporates patient centricity in drug development.

Q&A explores the evolution of community-based studies-and the related sample management, regulatory, compliance, and logistics support considerations.

The clinical trials space has shifted to a patient friendly, fast and easy process thanks to technological improvements, despite some gaps in the existing model. A Clinical Research Care Option (CRCO) can fill these gaps by fostering a more inclusive clinical research environment.

Combining PRO data with clinical feasibility data can make a difference in diabetes care.

Patients in Europe have been increasingly vocal in their demands for engagement in drug development and regulatory processes-and they have been increasingly effective.

Results show pharmacists are an important vehicle for increasing clinical research literacy.

All measurements and outcomes need to reflect what is happening with the patient.

Access to all available medical evidence can profoundly improve treatment effectiveness.

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.