News & Events October Newsletter

Working with Adjudication Committees

October 31, 2019

Working With Adjudication Committees
As treatments and study designs focused in rare and orphan diseases continue to become more innovative and complex, so too does the challenge of reporting scientifically measurable, objective, and valid endpoints. Studies that are based on endpoints with subjective components and a lack of standard clinical definitions, or that are subject to variability, require processes to standardize endpoint reporting for statistical analysis. 

 

Evolving Requirements
The implementation of an Endpoint Adjudication Committee (EAC), also known as a Clinical Endpoint Committee (CEC), is becoming an increasingly common solution to this problem. In short, these committees review designated endpoint events in an unbiased, blinded fashion. Regulatory authorities are gradually requiring such committees for certain indications, particularly those with complex endpoints. For example, the FDA’s guidance for Type II Diabetes requires an EAC to evaluate cardiovascular risks and the EMA requires an EAC to evaluate time to clinical worsening in pulmonary arterial hypertension studies.

What is an EAC or CEC?
The EAC/CEC functions under the parameters laid out in FDA’s Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. The EAC consists of an independent panel of experts in the relevant therapeutic area who are trained on the study protocol. The EAC/CEC convenes on a regular basis to:
  • Review blinded study data and endpoint-related events defined by the protocol,
  • Review functions to validate or oppose classification of endpoints that have been assessed by Sponsors and Investigators, and
  • Identify possible endpoints not previously investigated
The EAC’s unbiased reviews are provided to the Data Monitoring Committee (DMC) or the sponsor and are used to impact important decisions, such as safety reviews, power estimations, sample size re-estimation, efficacy analysis, and safety analysis. Additionally, the frequent meetings of the EAC enable early identification of safety or efficacy issues, making the EAC integral for adaptive study designs and a potential cost-saving measure. 
How CTI Can Help
CTI has extensive experience in designing and executing Endpoint Adjudication Committee programs and can assist with all stages of the committee’s lifecycle. The CTI Multidisciplinary Team can collaborate with the sponsor and regulatory agencies to determine the appropriate endpoints to be adjudicated, the appropriate data required and develop an efficient, secure method to share data with the Committee members.  CTI also develops the charter ensuring compliance with regulatory guidelines, identifies committee members, collects the data from various sources, conducts the analysis, manages the meetings and provides strategic direction.  Sponsors can expect unparalleled support as CTI’s EAC team provides assistance in navigating the complex EAC process.

To find out more about our expertise and how we can help you with running your clinical program, visit our website or fill out our contact form to start a conversation with one of our team members.
 

The Year of the Employee

Every month, we'll be spotlighting one of our employees and their contributions to CTI. We are successful as a company because of our passionate and talented employees, who work tirelessly to bring life-changing drugs to patients around the world.

Ashley Butler, MHA
Manager of Project Management, Regulatory & Scientific Affairs
Ashley joined CTI in 2014 as an Assistant Project Manager, quickly progressing through several roles before reaching her current title, Manager of Project Management, Regulatory & Scientific Affairs.

Ashley supports every facet of the RSA team's work, serving as an eCTD regulatory specialist and medical writer, providing oversight for project managers on the team, and performing some project management duties herself when a program needs additional support. In addition to her project-specific work, Ashley also spends a portion of her time mentoring and assisting junior members of the team.  Her favorite part about her role is "how every day, [she does] something completely different than the day before, be it a different project, working with a different client, or working with a completely different indication."

 
Want to join Ashley and our CTI team? Click to see our current job opportunities, including new expansion across the United States!
 

Additional Highlights

Upcoming Meetings We'll be Attending

ISPOR EU                                                                   BIO Europe
Copenhagen, Denmark                                               Hamburg, Germany
November 2-6                                                             November 11-13

ASN Renal Week                                                       World Orphan Drug Congress
Washington, D.C.                                                        Barcelona, Spain
November 5-10                                                           November 12-14

AASLD                                                                       DIA RWE Congress
Boston, MA                                                                 Cambridge, England
November 8-12                                                           November 14-15
 
 
 
CTI Cares 
The Instituto Vidas Raras - IVR (Rare Lives Institute) is a national non-profit. non-governmental organization located in São Paulo, Brazil. Its purpose is to promote the constitutional rights of socially vulnerable patients that need most
Learn more and donate
New Hires & Promotions
 
CTI is thrilled to welcome all of our new employees, and to congratulate our recently promoted employees! 
Join Our Team!
 

We're looking to build our team in the following US cities:
  • Atlanta, GA
  • Boston, MA
  • Chicago, IL
  • Cincinnati, OH
  • Covington, KY
  • Dallas, TX
  • Houston, TX
  • Indianapolis, IN
  • Philadelphia, PA
  • Raleigh, NC
  • San Francisco, CA
  • San Diego, CA
  • Washington DC
Search Open Positions

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