Applied Clinical Trials-01-01-2003

The interest in exploiting the Internet and its associated technologies to revolutionize the conduct of clinical trials continues to be discussed at length in journals and at conferences.1-4 Although increasing numbers of clinical trials are being commissioned and performed as e-studies, the general take-up is still low when compared with traditional methods. Estimates suggest that approximately 5-10% of all clinical trial data are collected and managed currently as e-trials.5

Six years ago, our department of a large academic research center was having difficulty enrolling enough subjects in osteoporosis studies. We wanted to expand into a variety of trials and increase the number of participants. Despite our experience and expertise, our enrollments were down. We wondered if the pool of eligible participants was shrinking, if our competition was doing a better job than we were, or if we needed to modify our project management style.

European organizations express their concerns over the implications of the EU guidances issued in response to the 2001 directive.

New technologies allow prospective subjects to absorb information about a trial at each individual?s pace.

Web services and the concept of technology integration are hot new trends that may have a major impact on the way we do business and manage data.

Congressional efforts to establish a Medicare pharmacy benefit will affect R&D, and a new FDA commissioner promises change.

Sometimes a new year requires a new approach

Lessons learned?and shared?by a recruiter can help you to get your message to potential subjects successfully and direct your path through a major roadblock to the speedy completion of trials.