Transcription of 13 – Essential Elements in Clinical Trial Assessment
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13 – Essential Elements in Clinical Trial Assessment
L1. 13 Essential Elements in Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I. Office of Clinical Trials Therapeutic Products Directorate 1. Slide 1. L1 Lourenco; Disclaimer: the information within this presentation is based on the presenter's expertise and experience, and represents the views of the presenter for the purposes of a training workshop 2. Overview Sufficient evidence (safety, efficacy, and quality). Enabling regulatory framework Good review practices when assessing a Clinical Trial Challenges & strategies Lessons learned from the Canadian experience 3. Sufficient Evidence Sufficient evidence signifies a positive benefit- to-risk ratio based on a sum of all of the following: Acceptable Quality (CMC) for the phase of development Acceptable supporting nonclinical and Clinical data (as applicable) for the phase of development, type of drug and/or disease target Acceptable protocol and informed consent form for the proposed Trial Maintenance of th
1 13 – Essential Elements in Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials
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