Complex Innovative Trial Design

by | Apr 3, 2023 | Clinical Trials, FDA, Regulatory, Testing

The FDA has recently been putting a much greater emphasis on working smarter not harder when conducting clinical trials. Types of clinical trial designs called Complex Innovative Trial Designs (CIDs) which come in response to the rapidly changing drug development environment have recently been getting a lot of attention. These designs allow clinical trials to answer more questions in less time. Often, the designs utilize “complex adaptive, Bayesian, and other novel clinical trial designs which can require elements of design and analysis approaches that require simulations to determine statistical properties of the clinical trial” (United States Food and Drug Administration, 2022).

While regulatory science may pose an issue, there are multiple different ways to help in implementing CIDs. These can include but are not limited to:

  • Using master protocols to expand the scope of trials so that they may evaluate multiple therapies or diseases within the trial.
  • Using Sequential Multiple Assignment Randomized Trials to give a structure for evaluating complex treatment algorithms.
  • Using Bayesian approaches to increase trial efficiency.
  • Developing new approaches for statistical analysis due to changes in enrollment of a study

If you need support for successfully implementing a CID to expand the efficiency of a clinical trial, the experts at EMMA International can help! Call us at 248-987-4497 or email us at to learn more.

Jacob Wright

Jacob Wright

Jacob Wright is a Quality Engineer at EMMA International with expertise in regulatory compliance, process validation, and quality management systems. He received his Bachelor of Science and Master's degrees in Biological/Biosystems Engineering from Michigan State University, where he developed a deep understanding of living organisms and engineering systems. Jacob's strong commitment to quality, attention to detail, and risk mitigation skills make him an effective advocate for regulatory compliance and product safety.

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