Applied Clinical Trials-05-01-2003

Applied Clinical Trials

Benchmarking Clinical Trials Practices in Central and Eastern Europe

May 01, 2003

Feature Article

Pharmaceutical companies and contract research organizations are setting up an increasing number of clinical trials in Central and Eastern Europe. The region offers attractive opportunities for sponsors to accelerate subject recruitment and to carry out clinical trials according to harmonized international standards and regulations. Recent concerns about data quality and cost-efficiency at CEE investigational sites, however, have led to regular evaluation of sites' clinical research performance and capacity. Now it is essential to introduce benchmarking and performance measurement to the conduct of clinical trials to identify best practices and to continually improve clinical research.

Opportunities to Improve Informed Consent

May 01, 2003

Feature Article

Improving the informed consent process and consent forms can not only help subjects better understand clinical research but also reduce the number of invalid consents obtained.

Subject Protection is Goal of Draft Guidance on Conflicts of Interest

May 01, 2003

View from Washington

HHS offers IRBs, institutions, and investigators points to consider when dealing with financial relationships and conflicts of interest in clinical research.

Rigor Vivus

May 01, 2003

Process Improvement

Postmarketing research is conducted differently than preapproval research, but data gained using different standards can be difficult to integrate.

European Ethics Committees?Still Salad Rather than Soup

May 01, 2003

View from Brussels

A newly completed study of European ethics committees finds that the bureaucracy of each country determines the way the ethics committees operate.

Letters to the Editor

May 01, 2003

Letters to the Editor

Readers respond to feature article and editorials.