FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design

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.

BENEFITS: Adaptive trials could allow for significant reduction in 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.

Get your hands on all the regulations, potential risks, various statistical considerations along with the logistical implications and practical use of adaptive clinical trial design with our expert presenter Dr. Mukesh Kumar. Case studies from drugs, biologics and medical device clinical trials will be used to highlight common errors and acceptable solutions.

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.

Here are a few highlights of the session:

  • Key US and EU regulatory requirements for adaptive clinical trials.
  • Building a rationale for adaptive trial design
  • Logistics of adaptive clinical trials: Do’s and Don’ts
  • Differences in using adaptive  trials for drug, biologic and medical devices
  • Case studies using real-life examples
  • Concept and examples of an Adaptive trial
  • Common Adaptation
    1. Sample size reassessment

    2. Discontinuing treatment arms

    3. Switching from non-inferiority to superior

    4. Adjustment of randomization ratio

    5. Combination of Phases (I/II, II/III, etc)

    6. Futility analysis
  • Indications studied using Adaptive Clinical trials
  • Major Benefits & Risks of Adaptive Design
  • Regulatory Issues and Key Questions for Consideration
  • Common criteria for Adaptive Design
  • Statistical Considerations
  • Valid Mid-course Adjustments
  • Safety Considerations
  • Contents of an Adaptive Design Protocol
  • Documentation to Protect Blinding & Information Sharing

Areas Covered in the Webinar:

  • Key US and EU regulatory requirements for adaptive clinical trials.
  • Building a rationale for adaptive trial design
  • Logistics of adaptive clinical trials: Do’s and Don’ts
  • Differences in using adaptive trials for drug, biologic and medical devices
  • Case studies using real-life examples

Who should attend?

  • Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies
  • Clinical trial Professionals such as project managers, CRAs, medical writers
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals
  • People investing in FDA-regulated products intended for the US market

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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