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Adaptive Trial Design


PPD is able to provide the robust real-time data acquisition, aggregation, cleaning and analysis capabilities that are the necessary foundations for successful execution of adaptive trial designs.

PPD provides robust real-time data acquisition, aggregation, cleaning and analysis capabilities.

Adaptive trial design provides a major opportunity for the industry to improve success rates in hematology and oncology drug development.

Properly planned and executed adaptive trial designs can have the following benefits:

  • Faster go, no-go decisions, saving sponsors time and money
  • Better early development decisions on the dose and frequency
  • Critical information to stop trials for ineffective or unsafe drugs more quickly, increasing safety and improving patient experience

Preclarus™

With the power of Preclarus™, PPD is able to provide the robust real-time data acquisition, aggregation, cleaning and analysis capabilities that are the necessary foundations for successful execution of adaptive trial designs.

PPD Adaptive Trial Design Preclarus
Case Studies

Unblinded Sample Size Re-Determination

This study evaluates a medication intended to delay declines in renal functioning.

Multiple Variable Dose Escalation

PPD was contacted by a small biotechnology company to provide a gap analysis for its clinical development plan to determine any adjustments required for a submission to the U.S. Food and Drug Administration (FDA).

Additional Resources

Challenges in Global Development of Genetically Modified Organisms Vector Immunotherapies

PPD offers insight on the impact of GMO regulations and how clients can better prepare for global development programs.

Adaptive Trial Design Sell Sheet

Learn how adaptive trial designs offer significant advantages for trial participants, patients and small and large molecule clients.

Collaboration with Berry Consultants

Berry Consultants is a statistical consulting group specializing in adaptive clinical trial design for pharmaceutical and medical device research and development. They are leaders in the field of Bayesian statistics as it relates to the medical industry.

Through this partnership, we are able to help clients plan for and effectively realize the benefits of adaptive trial design.

By implementing more advanced study designs and protocol optimizations, we are able to position trials for optimal success before the first patient is enrolled. In addition, PPD’s partnership with Berry Consultants extends our experience in advanced simulation and helps provide clients increase efficiency in their complex trials.

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