How Do You Resolve Clinical Trials Safety and Efficacy Events?

Oct 28, 2015

Although the world of clinical trials has well-established procedures and operational processes, the emerging field of Endpoint Adjudication is relatively new, and is rapidly gaining traction.

Endpoint adjudication is the process in which biopharmaceutical and medical device enterprises resolve events related to clinical trial safety and efficacy.  This process typically involves an Endpoint Adjudication Committee, which is an independent group of medical experts that evaluate and offer opinions on specific clinical trial events.  However, the adoption of endpoint adjudication as a business process and operational concept seems to be widely unknown and rarely spoken about in the industry.

Applied Clinical Trials is collaborating with the Clinical Endpoints Adjudication Group to conduct an industry survey to evaluate the impact of technology on endpoint adjudication processes. Applied Clinical Trials will publish the results in a future article.  The survey below should take less than five minutes to complete. 

CBI’s Endpoint Adjudication Conference is back for May 2018! Regardless of your therapeutic area, this in-depth conference provides attendees with strategies to manage the complex adjudication process by offering practical insights for independent review committee selection and charter development as well as compiling information from various sources to provident consistent, reliable and accurate data to be submitted for adjudication.


Learn More at the 4th Annual Endpoint Adjudication Conference and hear from FDA Senior Reviewer Andrew Farb, MD. 
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