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Review
. 2020 Dec;58(12):1235-1248.
doi: 10.1038/s41393-020-00547-8. Epub 2020 Sep 16.

Adaptive trial designs for spinal cord injury clinical trials directed to the central nervous system

M J Mulcahey  1 , Linda A T Jones  2 , Frank Rockhold  3 , Rϋediger Rupp  4 , John L K Kramer  5 , Steven Kirshblum  6   7 , Andrew Blight  8 , Daniel Lammertse  9 , James D Guest #  10 , John D Steeves #  5
Affiliations
Review

Adaptive trial designs for spinal cord injury clinical trials directed to the central nervous system

M J Mulcahey et al. Spinal Cord. 2020 Dec.

Abstract

Study design: Narrative review.

Purpose: To provide an overview of adaptive trial designs, and describe how adaptive methods can address persistent challenges encountered by randomized controlled trials of people with spinal cord injury (SCI).

Results: With few exceptions, adaptive methodologies have not been incorporated into clinical trial designs of people with SCI. Adaptive methods provide an opportunity to address high study costs, slow recruitment, and excessive amount of time needed to carry out the trial. The availability of existing SCI registries are well poised to support modeling and simulation, both of which are used extensively in adaptive trial designs. Eight initiatives for immediate advancement of adaptive methods in SCI were identified.

Conclusion: Although successfully applied in other fields, adaptive clinical trial designs in SCI clinical trial programs have been narrow in scope and few in number. Immediate application of several adaptive methods offers opportunity to improve efficiency of SCI trials. Concerted effort is needed by all stakeholders to advance adaptive clinical trial design methodology in SCI.

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References

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