The success of an Endpoint Adjudication Committee (EAC) is highly dependent upon the quality of the information provided to the adjudicators. Sponsors can greatly improve the clinical data presented to adjudicators by adding clinical oversight to the adjudication process.
Collecting high quality source data from investigative sites can sometimes prove challenging. Inconsistent and incomplete information can put a trial at risk for possible poor adjudication outcomes, such as cases that cannot be assessed, lead to higher rates of readjudication, and culminate to possible delays in adjudication turn-around.
There are many advantages to establishing a strong clinical voice on each adjudication project. An experienced clinical team member can enhance adjudication results by reviewing all source documentation to identify any missing or inconsistent data before it is presented to the EAC. In doing so, they can blind specific clinical data in order to prevent adjudication member bias and can even provide guided narratives that can equip the adjudicators with crucial data when information is limited or endpoint adjudication is complex. Additionally clinical team members can easily collaborate directly with the medical experts serving on the EAC during charter development. Through the collaboration, the clinical team can develop clear charter event definitions that adhere to current literature and accepted standards in the respective therapeutic area, which will allow for more consistent adjudication results.
Many sponsors struggle to commit the right level of in house medical support needed for clinical oversight due to resourcing or high case volume. As an industry leader in Endpoint Adjudication, ACI Clinical has a talented, dedicated clinical team that can guide sponsors through the complex adjudication process, provide highly-detailed clinical review, and ensure quality information is provided to the adjudicators. Many of our team members have over a decade of clinical trial experience in a variety of therapeutic areas and all are highly committed to excellence and on time delivery of quality adjudication results.