FDA Faces New Leadership and Major Changes
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
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
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
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
Good organization and technological support are needed to bring the benefits of electronic data capture to a clinical trial.
Informed Consent Process
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
A survey of pharmaceutical manufacturers reveals that pediatric trials are widespread across Germany.
