This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
In August the European Medicines Agency (EMA) released a reflection paper on risk based quality management in clinical trials. Comments are being accepted until February 15, 2012. Click here to view.
An FDA perspective on its new regulation to improve safety reporting in clinical trials was published online by the New England Journal of Medicine . Click here to view the article.
Drs. Elliott Levy and Beverly Lorell, co-chairs of the CTTI Steering Committee, are pleased to announce that Bray Patrick-Lake has been selected to serve as a patient representative on the CTTI Steering Committee.
Patient representatives serve an important role in providing valuable perspectives and input to Steering Committee discussions and decisions. They also serve as liaisons with the patient advocacy community. Ms. Patrick-Lake serves as President and CEO of the PFO Research Foundation, which she founded in 2010 for the purpose of advancing PFO science and improving...
The results of a CTTI study assessing how clinical trial quality is monitored in the U.S. was published online today in the journal Clinical Trials .
CLICK HERE to view the publication.
CLICK HERE to view the press release.
CTTI will report on the progress and results of several key projects at the Society for Clinical Trials (SCT) annual meeting taking place on May 16 - 18, 2011, in Vancouver, Canada.
On Tuesday, May 17, team leads will present the results of a research project to improve safety reporting to IND investigators, including primary research findings, patient perspectives, and expert panel conclusions. A representative from FDA will discuss the implications of the new FDA premarketing safety reporting requirements in this context.
On Wednesday, May 18, there will be a CTTI panel...