The Food and Drug Administration (FDA) Office of Communications, Division of Drug Information Center for Drug Evaluation and Research released the “Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry.”

The Summary

The FDA recently offered published guidance to sponsors and applicants submitting investigational new drug applications (INDs) and new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a particular drug or biologic investigational product.

Overview

By describing important principles in the design, conduct and generation of report resulting from adaptive clinical trials, the FDA via the guidance offers sponsors advise and counsel on the types of information to submit to facilitate FDA evaluation of adaptive designs supporting clinical trials—involving Bayesian adaptive and complex trials that rely on computer software-driven simulations for their design.

What are Adaptive Trials?

An adaptive design is a clinical trial design that allows for prospectively planned modifications to one or more trial design aspects based on the accumulating data generated from participants in the trial.

History

Back in 2004, the FDA introduced a “Strategic Path” to help accelerate the way drugs traveled from lab to market. High attrition levels in clinical phases raised growing concerns that something needed to be done. Hence heretofore unavailable flexible models were contemplated to offer investigators more flexibility to find that optimal clinical benefit without materially affecting a particular clinical trial’s validity. Hence, the introduction of the Adaptive clinical trial. https://www.news-medical.net/whitepaper/20130916/Adaptive-Clinical-Trials-for-Overcoming-Research-Challenges.aspx

What are the Benefits of Adaptive Clinical Trials?

The Adaptive clinical trial empowers the sponsor and investigator to capitalize on real-time observed outcomes during the study by adapting and modify the parameters of the trial protocol in accordance with the observations.  The adaptation process often can occur throughout the clinical trial, as delineated, the in the clinical trial protocol. As the trial unfolds, sponsor and investigator can make further modifications that can involve drug dosage, sample size, specific drug of study, patient selection criteria, and “cocktail mix.” https://www.outsourcing-pharma.com/Article/2013/06/05/CROs-Slowly-Shifting-to-Adaptive-Clinical-Trial-Designs  Some trials are designed as more of an ongoing process empowering the sponsor and investigator to regularly add or drop therapies and patient groups as more actionable intelligence is developed and understood

The Adaptive clinical trial protocol is set prior to commencement of the study—e.g. the protocol pre-specifies the adaption schedule and process.

Call to Action: Follow the link to read and better understand FDA Guidance for Adaptive Designed for Clinical Trials.

Source: U.S. Food & Drug Administration

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