Applied Clinical Trials-03-01-2004

Policymakers want to harmonize for safety reporting, IRB operations, patient access, and other areas to spur product development.

ACT Editorial Advisory Board members are experts in their field who volunteer to review and comment on manuscripts being considered for publication. EAB members also provide valuable feedback on special programs and projects as well as keep our editorial staff current on the state of the industry. ACT would like to welcome two new members to our Editorial Advisory Board, Scott Grisanti and Uwe Gudat, as well as introduce them to our readers.

Subject safety in clinical trials has received much recent media attention, most publicly because of the death of a young man during a gene therapy study at the University of Pennsylvania.1 Some large and important clinical trials have been halted before their planned conclusions for safety and other concerns (for example, the Women's Health Initiative).2

Medidata Solutions's Vision Developer, Gentiae Clinical Research, Inc.'s LifeSignals, and Integic Corp.'s CRF WorkManager

Arbitrarily scheduled meetings eat away at valuable time otherwise spent actually getting things done.

When FDA commenced discussions on the use of electronic records in lieu of paper records in 1991, it embarked upon a six-year consultation exercise culminating in the issuance of the final rule "21 CFR 11,"1 which came into force on 20 August 1997. The final rule itself is succinct (approximately 2000 words), but has given rise to massive amounts of commentary and interpretative text. The latest guidance aims to address issues with these secondary texts rather than the rule itself.

With increasing authority, the EMEA is indeed living in interesting times.