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Clinical Events Committee (CEC)

The CEC identifies/chartered suspected events by systematic review of clinical; including biomarkers related to the events of interest (i.e. cardiac enzyme, autoimmune panel, etc.) and other tools including procedure related to the events of interests (i.e. electrocardiographic data, tumor flares associated with T- cell infiltration including, etc.). Data is captured on standard case report forms. Information collected for all patients (i.e. cardiac enzymes, ECGs (at the time of the qualifying episode, at enrolment, at 24 hours, at initial discharge, and at 30 days), revascu-larisation procedure reports, and details of ischemic episodes, clinical complications, medications, and readmission records). All enzyme values for each patient are reported, and study monitors verified them against source documents. For patients with suspected events (i.e. MI, Immune- mediated adverse events) site investigators would submit supporting documents and to include discharge summaries (i.e. additional ECGs during the suspected event, etc.). An independent, blinded, data review (i.e. ECG Core Laboratory read the ECGs and identified suspected MIs, etc.) will be defined. A central and independent adjudication process is established.

Cardiac: The CEC charter would assure:

    The disagreements between the site investigators and CEC by re- reviewing patients. Re- review is blinded to patient treatment assignment. Patients may be categorized during the re- review in clinically meaningful groups, evidence of the cardiac events including patients with performed procedures including revascularization procedures, asymptomatic cardiac enzyme elevation; post- enrolment, and clinically significant cardiac events resulting in death vs. sudden death without any other evidence.

    Statistical analysis will review the disagreements and suspected events. This is a blinded review of the data. Comparisons by treatment assignments included comparator analysis between placebo, different doses/regiments of the study medication, as well as a protocol compliant/dose standard regiment arms/groups with the primary efficacy analysis in a trial analysis. P values may be calculated using X2 test.

Secondary Malignancy, subpopulation exacerbation of COPD events in the PDE- 4s, etc. Disease population, subpopulation, special events of interest analysis, etc. would be reviewed by the CEC as needed in an independent analysis.
Current clients include Top BioPharmas as well as a TOP Device company in the US.

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