Regulatory Focus™ > News Articles > FDA Announces Series of Workshops Looking at Clinical Trial Design

FDA Announces Series of Workshops Looking at Clinical Trial Design

Posted 15 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has announced a series of public workshops aimed at addressing the design of clinical trials and the role of clinical and regulatory professionals.

Kidney Transplantation

An 11 September 2012 workshop held by the agency will discuss the clinical endpoints for products used during kidney transplantation, including drugs and therapeutic biologics. FDA said the workshop was specifically aimed at obtaining information about the,"Various clinical, laboratory, histologic, genomic/proteomic, safety, and other endpoints used to evaluate patient and allograft outcomes."

"The meeting will include a discussion of measure of patient and graft survival, evaluation of the allograft by histology and biomarkers, glomerular filtration rate or other measures of renal function, evaluation of safety, and other topics," explained FDA, with the results of the meeting potentially informing the development of future recommendations on the topic.

Design of Clinical Trials for Antibacterials

A 7 September 2012 workshop sponsored by FDA will focus on how clinical trials for antibacterial drugs for certain forms of bronchiectasis not caused by cystic fibrosis are designed. The agency notes input from the meeting will go toward the development of future topics of discussion.

Good Clinical Practices

A 14-15 November 2012 workshop held jointly between FDA and the Society of Clinical Research Associates is set to look at the responsibilities of those in charge of clinical trials and "facilitate interactions" between FDA representatives and the public. Topics will reportedly include how FDA interacts with clinical staff, investigators and institutional review boards.

An identical workshop will be held on 6-7 March 2013 in Dallas, Texas.


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