Applied Clinical Trials-06-01-2002

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

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?

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.

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

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.

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.

Readers respond to articles and editorials.

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

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.

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

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

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