Applied Clinical Trials-09-01-2001

CDISC has broad support for its fledgling standard whose evolution is critical to the acceleration of technology adoption in clinical trials.

As the public clamors for early access to promising new drugs, sponsors worry about the consequences of experimental therapy conducted outside of controlled trials.

Patients, research companies, and regulatory authorities may all benefit from proposed changes to current pharmaceutical legislation, but the proposals will provoke much debate.

Readers share their experience

Michael R. Hamrell, PhD, Ed., (Drugs and Pharmaceutical Sciences, volume 104, Marcel Dekker, New York, 1999), 224 pages, hardcover, ISBN 0-8247-0309-X, $135.

Readers share their experience

Combining the principles of adult learning with the advantages of Web technology can engage participants in important investigator meetings.

New systems of ethical oversight for randomized controlled trials could ease the problems caused by increasingly cumbersome restrictions.

EN ISO/IEC 17025 is more evidence that international standards are evolving to keep pace with technology and improve the performance of accredited central laboratories.

As well as being a committed European, Domenico Criscuolo is a powerful supporter of the Italian clinical research community.

A creative mobile monitoring model could help sponsors tap the potential of southern Europe (and Mexico) as areas for clinical research.