Adaptive Clinical Trial (ACT)

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An Adaptive Clinical Trial (ACT) is a Clinical Trial that modifies parameters of the clinical trial protocol after observing clinical trial participant outcomes.



References

2021

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Adaptive_clinical_trial Retrieved:2021-11-13.
    • An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes (and possibly other measures, such as side-effects) on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations. The adaptation process generally continues throughout the trial, as prescribed in the trial protocol. Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained.[1] Importantly, the trial protocol is set before the trial begins; the protocol pre-specifies the adaptation schedule and processes.

      The aim of an adaptive trial is to more quickly identify drugs or devices that have a therapeutic effect, and to zero in on patient populations for whom the drug is appropriate.[2] A key modification is to adjust dosing levels. Traditionally, non-adverse patient reactions are not considered until a trial is completed. [3]

      The problem of adaptive clinical trial design is more or less exactly the bandit problem as studied in the field of reinforcement learning.

  1. Brennan, Zachary (2013-06-05). "CROs Slowly Shifting to Adaptive Clinical Trial Designs". Outsourcing-pharma.com. Retrieved 2014-01-05.
  2. Wang, Shirley S. (2013-12-30). "Health: Scientists Look to Improve Cost and Time of Drug Trials - WSJ.com". Online.wsj.com. Archived from the original on 2016-03-14. Retrieved 2014-01-04.
  3. Peter W. Huber (12 November 2013). The Cure in the Code: How 20th Century Law Is Undermining 21st Century Medicine. Basic Books. ISBN 978-0-465-06981-1.

2019

2018

Table 1 lists some well-recognised adaptations and examples of their use. Note that multiple adaptations may be used in a single trial, e.g. a group-sequential design may also feature mid-course sample size re-estimation and/or adaptive randomisation (...), and many multi-arm multi-stage (MAMS) designs are inherently seamless (...). ADs can improve trials across all phases of clinical development, and seamless designs allow for a more rapid transition between phases I and II (...) or phases II and III (...).
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Figure 1: Schematic of a traditional clinical trial design with fixed sample size, and an adaptive design with pre-specified review(s) and adaptation(s).

2016

2014

  • (Chow, 2014) ⇒ Shein-Chung Chow. (2014). “Adaptive Clinical Trial Design.” In: Annual Review of Medicine, 65.
    • There is no universal definition: Adaptive randomization, group sequential, and sample size re-estimation, etc. (Chow, Chang and Pong, 2005), (PhRMA, 2006)
    • Adaptive design is also known as: Flexible design (EMEA, 2002, 2006), Attractive design (Uchida, 2006)
    • Characteristics:
      • Adaptation is a design feature.
      • Changes are made “by design” not on an “ad hoc” basis.
    • Comments
      • It does not reflect real practice.
      • It may not be flexible as it means to be.

2010