Applied Clinical Trials-09-01-2003

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

As information technology becomes more important to clinical trials, the EU is discussing how IT should be included in clinical trials legislation.

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

It is increasingly important for clinical trial personnel to break through the obstacles that language and culture present when conducting trials away from their home countries.

Restrictive regulations and cultural differences make regulatory approval in Japan elusive, but adopting new strategies may make that lucrative pharmaceutical market more accessible to non-Japanese companies.

FDA plans to rewrite rules governing electronic records while offering new policies to encourage risk-based regulatory approaches to application review and inspections.

Application, software, Web-based solutions, and more.