P3‐389: Role of an adjudication committee in an Alzheimer's disease trial (the ARGO trial)

Le résumé fourni par la source

Adjudication committees (AC) are traditionally involved in the standard assessment of endpoints and milestones, but their role may be also relevant for patient selection at the time of study inclusion. A systematic process to review clinical information at screening in order to centrally confirm patient's eligibility may prove to be quite useful. Two board certified neurologists reviewed clinical data of all patients included in a phase II AD trial (ARGO) before randomization (for more information about the study, visit www.clinicaltrials.gov). A neuro-radiologist reviewed all MRIs performed at sites participating in the neuroimaging substudy. When information was missing or conflicting with inclusion or exclusion criteria, queries were raised and issues clarified. The electronic CRF, e-mail and occasional phone calls were the communication tools between AC and investigators. Of the 437 patients screened, 129 were considered screen failures. There was only one protocol violation in the study (a patient with a prolonged out-of-range QTc at baseline whose value at screening visit had been normal). The main reasons for not recommending patient eligibility coming from the AC were: abnormal lab values, prohibited medications, out-of-range neuropsychological assessments and MRI findings. The area of most conflicts was the MRI interpretation of vascular load. The advantages of an AC during the screening period include: early data entry into eCRF and prompt verification that reduce errors and potential data loss; real-time access to adjudicated data; almost elimination of protocol violations.

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