Blog
Sharing Clinical Trial Data & YODA
The culture of sharing and openness in the clinical trial data arena is improving – for sure, it’s being talked about. Large pharma and pharma associations are making pledges to make data collected more available. They are being careful to limit disclosure such that...
ACRP Circle City Chapter Symposium on October 3
On Monday, October 3rd, the ACRP Circle City Chapter will be hosting their 16th Annual Excellence in Clinical Research Symposium at the Ritz Charles in Carmel, Indiana. Save the date for this event which will be held from 7:30am to 5:00pm. Registration and agenda...
IRB Written Procedures Draft Guidance released
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs draft was released recently by the FDA and the Office for Human Research Protections (OHRP). This new draft guidance includes an IRB Written Procedures Checklist developed with the...
Phase I study death in France prompts EMA updated guidelines on FIH trials
In January of 2016, a Phase I drug trial in France, conducted by the French contract research organization Biotrial, left one volunteer dead and five others hospitalized: four with permanent neurological damage. The drug, named BIA 10-2474, is under development, by...
FDA Guidance on Adaptive Designs released
On July 27th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here. According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the...