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Adaptive Trial Design

Reducing Costs and Improving Efficiency in Clinical Development

Adaptive trial designs offer significant benefits for biopharmaceutical companies looking to reduce costs and streamline the drug development process, increasing efficiency and success rates for their clinical programs. Adaptive trials use accumulating trial data with a prospective design to determine how to change aspects of a study, while maintaining study validity and integrity.

The efficacy of the adaptive design and strength of conclusions are understood through state-of-the-art trial simulation techniques. These simulations allow clients to understand completely the adaptive design—building designs as though they were looking at the data and making decisions.

PPD’s experience in planning and executing adaptive trials can deliver significant advantages to our clients through:

  • In-depth global resources, including industry-leading biostatistical, medical and regulatory expertise
  • Close consultation with clients, beginning in early development, to explore the advantages and requirements of an adaptive design approach and define an appropriate strategy
  • Diverse therapeutic experience in adaptive trial designs, including oncology, general medicine, nervous system disorders, metabolic disorders, infectious diseases and autoimmune disorders
  • A strong collaboration with Berry Consultants, a leading statistical consulting group specializing in adaptive clinical trial design with a long history of building adaptive Bayesian designs

Complete Expertise and Resources to Plan and Execute Adaptive Trial Designs

The investment in early, in-depth planning utilizing adaptive trial designs can lead to significant benefits, including:

  • Faster “go/no-go” decisions, saving time and money by more efficiently allocating subjects in the trial to the most effective doses, creating a better understanding of the efficacy and safety profile
  • Better early development decisions on the dose and frequency, increasing the likelihood of Phase III success
  • Critical information to stop trials for ineffective or unsafe drugs more quickly, increasing safety and improving patient experience

PPD and Berry Consultants

Berry Consultants is a statistical consulting group specializing in adaptive clinical trial design in pharmaceutical and medical device research and development. PPD formally collaborates with Berry Consultants to complement PPD’s in-house adaptive statistical expertise and bring our clients the industry’s leading expertise on adaptive trial design and Bayesian biostatistics.

Through our collaboration with Berry Consultants, PPD provides clients extensive experience and seasoned leadership to develop comprehensive plans utilizing adaptive clinical trials, as well as the expertise, resources and infrastructure to execute them successfully.

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New Adaptive Blinded Sample Size Adjustment Method for Risk Differences in Clinical Trials

Adaptive Trial Design Article

Method for ensuring adequate power, without unblinding a trial that compares two response rates.

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