Clinical Endpoint Adjudication

Independent endpoint adjudication is used to systematically classify clinical outcomes in clinical trials in an unbiased way. SCCR faculty and operations staff have extensive experience in clinical endpoint adjudication; they have led event adjudication in over 210 clinical trials with over 115,000 endpoints adjudicated. The SCCR CEC operations team and faculty physician adjudicators have resources and clinical expertise to provide comprehensive adjudication services in support of research programs in all phases of development.

Our broad network of adjudicators has expertise in various therapeutic specialty areas.  The CEC operations team supports and manages CEC operations under the leadership of Dr. Ken Mahaffey.

Dr. Mahaffey is an international thought leader in clinical endpoint adjudication; Dr. Mahaffey has led the Standardized Data Collection for Cardiovascular Trials Initiative, in collaboration with the US Food and Drug Administration, to develop uniform definitions for cardiovascular and stroke outcomes.

The SCCR CEC program provides the following capabilities:

• • CEC charter development with endpoint definitions
  • Clinical Database Endpoint case report form development
  • Adjudication form development
  • Development and execution of CEC Project Management Plan
  • Training of study site investigators and staff, and adjudicators
  • Management of electronic adjudication platforms
  • Quality control procedures

Classical Endpoint Classification

CEC is an independent and unbiased committee made up of Physician Reviewers with therapeutic area expertise who systematically and consistently apply pre-defined event definitions to adjudicate clinical endpoints. Clinical endpoints are outcome measures of the occurrence of disease or symptoms within a target population in a clinical trial. The CEC committee functions independently from sites and sponsors to objectively measure clinical outcomes that characterize the safety and efficacy profile of an investigational drug or device.

Clinical Event Adjudication Process

The adjudication process is key to the measurement of clinical outcomes in pivotal clinical trials. CEC employs a method of event classification that significantly reduces variability in clinical event reporting across sites, investigators and geographic regions. This approach standardizes the classification and reporting of clinical endpoints and strengthens the overall quality of the data set. The adjudication results are used in the final analyses of clinical trials to establish whether trial objectives were met, which regulatory authorities consider when reviewing regulatory submissions.