Applied Clinical Trials-11-01-2002

Applied Clinical Trials

FDA Faces New Leadership and Major Changes

November 01, 2002

View from Washington

The agency is shifting regulation of biotech therapies to its drug center, a streamlining initiative to be implemented by a new FDA commissioner.

Taking European Clinical Expertise to Africa

November 01, 2002

View from Brussels

The World Summit on Sustainable Development may have fizzled, but a promising new long-term clinical trials partnership between the EU, industry, and developing countries is in the works.

Successful Subject Recruitment: One Size Does Not Fit All

November 01, 2002

Feature Article

Successful recruitment requires a good fit between the subjects, the sites, and the protocol. Here?s how to assess the necessary tailoring of procedures.

The HIPAA Privacy Rule Affects Subject Recruitment

November 01, 2002

Feature Article

A health care attorney clarifies how amendments to the HIPAA Privacy Rule bear on the recruitment of clinical trials subjects.

Planning Helps Project Managers and CRAs Meet the Challenges of: The Move to EDC

November 01, 2002

Feature Article

Good organization and technological support are needed to bring the benefits of electronic data capture to a clinical trial.

Informed Consent Process

November 01, 2002

Feature Article

The results of a Web-based survey of some subjects in recent clinical trials suggest ways to improve the consent process.

Pediatric Clinical Trials in Germany

November 01, 2002

Feature Article

A survey of pharmaceutical manufacturers reveals that pediatric trials are widespread across Germany.