Applied Clinical Trials-06-01-2002

View from Washington
Applied Clinical Trials

June 01, 2002

Rules to ensure confidentiality of individual health information threaten to make clinical trials more complex and costly.

Feature Article
Applied Clinical Trials

June 01, 2002

The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?

Feature Article
Applied Clinical Trials

June 01, 2002

European inspectors are doing a better job of implementing ICH GCP guidelines than their American counterparts at FDA. Here are 10 ways U.S. inspectors could improve their inspection process.

Applied Clinical Trials

June 01, 2002

To judge the value of process improvement, companies need to understand the cost of doing business. The problem is: they don?t.

View from Brussels
Applied Clinical Trials

June 01, 2002

EU proposals are finally available for the pharmaceutical industry to begin commenting on, and you can bet the industry will take advantage of it.

The authors contrast two views on the regulations concerning electronic source data.

Feature Article
Applied Clinical Trials

June 01, 2002

An attorney who specializes in health law advises researchers and research organizations to study and put into practice the proposed changes in a rule that governs use and disclosure of protected health information.

Letters to the Editor
Applied Clinical Trials

June 01, 2002

Readers respond to articles and editorials.

Media Review
Applied Clinical Trials

June 01, 2002

Kenneth Getz and Deborah Borfitz, CenterWatch (Boston, MA, 2002) 306 pp., $16.95.

Feature Article
Applied Clinical Trials

June 01, 2002

As clinical trials become global affairs, more effort should be devoted to the protection of research subjects. However, the question of consistency among ethics committees looms.

Feature Article
Applied Clinical Trials

June 01, 2002

In a global survey, Roche asks investigators how to go about getting the best clinical trial sites.

Resources
Applied Clinical Trials

June 01, 2002

The European Forum for Good Clinical Practice (EFGCP) put together these guidelines as a push toward quality and efficiency in ethical review practices.

Feature Article
Applied Clinical Trials

June 01, 2002

In Europe, U.S. CROs aren?t doing as well as they could. Where they locate their offices could make the difference.