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Clinical Events Committees

By Ethical 28 May, 2019

Clinical Events Committees for Independent Endpoints Adjudication

Endpoint adjudication requires more than just expertise in the medical field. Several ways exist to select and put in place an efficient panel of experts.

Endpoint adjudication is required in the context of complex studies with multi-factorial safety and/or efficacy parameters that cannot easily be assessed by the investigators alone. These can range from inclusion patient characteristics to patient evaluability and of course, most frequently, safety assessment endpoints.

A panel of experts is therefore set as a Clinical Events Committee and asked to review and assess these complex endpoints in an unbiased blinded way. 
Clinical Events Committee members are required to have the necessary medical and sometimes technical expertise but this may not be sufficient for a smooth and efficient operation of the Clinical Events Committee.
Prior experience with clinical studies and with endpoint adjudication, familiarity with software platforms and even personal acquaintance between members are likely to make a big difference. Selecting the members of the Clinical Events Committee is not a trivial task and can have a huge impact on the conduct and even on the success of a clinical trial.

The usual criteria beyond medical expertise used to select Clinical Events Committee members are KOL status, prior collaboration with the sponsor and prior participation to similar committees. Larger sponsor companies with products on the market usually have strong bonds with the relevant medical communities and prefer to set their own mix of reviewers while earlier development stage companies look for institutions with sufficient reputation that can add to the study their notoriety.

Academic Research Organizations (ARO) offer such services backed by prestigious academic institutions (Stanford, Uppsala, Duke etc.)
These organizations offer the right mix of expertise, experience and name recognition and are often familiar with the most frequently used software platforms (EDC, e-adjudication). 

Ethical, an integrated endpoint adjudication company, has been working for years with important ARO and can then assist Sponsors in writing the adjudication charter and selecting individual Clinical Events Committee members or alternatively may offer an integrated service by collaborating with prestigious ARO to provide a full endpoint adjudication service in several medical fields.

 

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Clinical Event Committee - CEC

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