« Return to News | Study Conduct

British TaskForce Submits Recommendations for Phase I Guidelines

Monday, July 24, 2006 12:47 PM

The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) taskforce has established recommended guidelines to enhance patient safety in phase I studies with novel agents. The taskforce was created to address safety concerns following the events during the TeGenero trials with the immune stimulate TGN1412...

Specific recommendations included the use of an alternative dose assessment for certain novel agents, the administration of drug to only one subject on the first day, and the use of staggered dosing regimes. The taskforce also recommended better manufacturing controls to ensure quality, and the possibility of having some trials conducted in a hospital setting with access to intensive care facilities. The recommendations were submitted to Professor Gordon Duff, chair of the scientific expert group.

The 358-page interim report can be found on the ABPI's website in .pdf format.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.