Adaptive & Flexible Trials

Listening, learning, adapting.

Flexibility is one of the most powerful tools in your trial design arsenal. That’s why Adaptive Trial Designs give you the opportunity to reduce risk of failure by factoring in analyses at key points so study design parameters like sample size, dosage, or patient selection can be adjusted accordingly. 

In fact, a 2018 report we commissioned called The Innovation Imperative: The Future of Drug Development by The Economist Intelligence Unit (EIU) found that adaptive trial designs boost a new therapy’s likelihood of launch by 13% on average. That percentage climbs even higher in certain therapeutic areas – up to 32% for oncology. However, although this approach is encouraging, it’s still not widely used.

By implementing Adaptive Trial Designs you have the opportunity to carefully evaluate clinical data in real-time, so you can make informed decisions to change the direction of the study for a better chance of success. A well-designed and executed Adaptive Trial Design can:

  • increase the probability of success for your new therapy
  • maximize the information from the trial
  • shorten development timelines
  • reduce overall development costs and
  • reduce the risk for study volunteers and sponsors
  • maximize the probability of success with regulators and payers

 

Types of Adaptive Trial Designs

More services we provide:

  • Statistical expertise to develop Adaptive Trial Designs to optimize study plans and clinical development plans 
  • Biostatistics expertise in planning and execution of adaptive trials, Bayesian adaptive dose finding, sample size re-estimation, seamless designs to combine phases of development, performing simulations of design and decision scenarios
  • Project leadership with experience in managing Adaptive Trial Designs:
    • We develop the entire plan, bringing in all the disciplines: scientists, data managers, statisticians, medical experts, regulatory experts, logistics, and technology experts. They are all there to provide their input into the design and execution of the trial
    • Clinical monitoring resources who understand the effects of rapid design shift impacts on on-site workload, site motivation and retention, etc. 
    • Data management staff with experience in adapting database structures to changing study designs
    • Integrated technology components through Parexel Informatics including EDC, ePRO, IVR, supplies simulation and forecasting
    • We partner with the right technology developers to work on flexible data platform solutions to gather, synthesize and analyze the data from different sources 
    • Regulatory experts that have relationships with different regulatory agencies and can speak to the regulatory agencies expectation to maximize acceptability of the particular development plan 

We are always available for a conversation.

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