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Which study type is that? A guide to study types

Study and experiment types for Health Sciences and Medicine

Adaptive clinical trial


Adaptive clinical trials allow for modifications to the procedures based on the interim results. Unlike traditional trials that have fixed protocols, adaptive trials use pre-specified rules that allow adjustment to elements such as sample size, dosage or treatment allocation. The flexible nature of this type of trial can improve efficiency because it focusses resources on more promising treatments and reduces participant exposure to less effective treatments. Adaptive trials are valuable in areas where a rapid response to findings is critical.

 

adaptive clinical trial

Adaptive trial characteristics:

  •     Key study design components can be adapted throughout the trial
  •     Trial planning involves several rounds of simulations
  •     Consequences and gains of possible trial adaptations need to be understood before initiation
  •     Statistical analysis plans are needed for both interim and final analyses
  •     Research question may change along with adaptations (for example, narrowing the population)
  •     Multiple trials (such as phase II and III) can seamlessly be combined in one adaptive trial
  •     New experimental treatments can be added rather than starting a new separate trial

Thorlund, K., Haggstrom, J., Park, J. J., & Mills, E. J. (2018). Key design considerations for adaptive clinical trials: a primer for clinicians. bmj, 360.

Further reading and resources

  • Adaptive clinical trial series. (2017). The Biomedical & Life Sciences Collection, Henry Stewart Talks. (Search for adaptive clinical trial to view the series). Catalogue Link
     
  • Chow, S. C., & Corey, R. (2011). Benefits, challenges and obstacles of adaptive clinical trial designs. Orphanet journal of rare diseases, 6, 1-10. Full Text
     
  • Chow, S. C., & Song, F. (2017). Adaptive clinical trial design. Quantitative Methods for HIV/AIDS Research, 41-62. Full Text
     
  • He, W., Pinheiro, J., & Kuznetsova, O. M. (Eds.). (2014). Practical considerations for adaptive trial design and implementation. Springer. Catalogue Link
     
  • Pallmann, P., Bedding, A. W., Choodari-Oskooei, B., Dimairo, M., Flight, L., Hampson, L. V., ... & Jaki, T. (2018). Adaptive designs in clinical trials: why use them, and how to run and report them. BMC medicine, 16, 1-15. Full Text

Example

Brosseau, G., Pagé, N., de Jaham, C., & Del Castillo, J. R. (2020). Medical honey for canine nasal intertrigo: A randomized, blinded, placebo-controlled, adaptive clinical trial to support antimicrobial stewardship in veterinary dermatology. Plos one, 15(8), e0235689. Full Text

 

 


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