FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design
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Deadline: May 15, 2014 | Date: May 15, 2014
Venue/Country: 38868 Salmon Ter, Fremont, U.S.A
Updated: 2014-04-17 18:03:21 (GMT+9)
Call For Papers - CFP
Instructor: Mukesh KumarDescription:Mid-way during an ongoing clinical trial, critical information may be anticipated, that could potentially influence the outcome of the entire trial. The trial may benefit enormously if it can be modified to address mid-study new information. A clinical trial design that allows such a modification is called an Adaptive Clinical Trial. Adaptive trials could allow for significant reduction in the cost and time to market for the products under development, and can also increase the probability of success of the development program. Such trials can be employed for all kinds of FDA-regulated products. This seminar will discuss key statistical and regulatory strategies for adaptive clinical trials based of guidance from FDA and case studies.Why Should you Attend:Adaptive clinical trials are getting increasingly common across all product types due to the obvious advantages over conventional trials. Even pivotal studies could be of adaptive design. However, there are critical issues with design, statistical justification, logistics, and site management for an adaptive trial that could lead to a failed study if not addressed appropriately. This webinar will discuss the regulations, statistical considerations, logistical implications and practical applications of adaptive clinical trial design. Case studies from drugs, biologics and medical device clinical trials will be used to highlight common errors and acceptable solutions. Objectives of the Presentation:Key US and EU regulatory requirements for adaptive clinical trials.Building a rationale for adaptive trial designLogistics of adaptive clinical trials: Do’s and Don’tsDifferences in using adaptive trials for drug, biologic and medical devicesCase studies using real-life examplesWho can Benefit:This webinar will provide valuable information to:Manufacturers of FDA regulated products: Drug, Medical Device and Biotech CompaniesClinical trial Professionals such as project managers, CRAs, medical writersSenior Management for companies developing new products for US marketRegulatory Affairs ProfessionalsPeople investing in FDA-regulated products intended for the US markethttp://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500295?expDate=Ourglocal
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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