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SMARTer discontinuation trial designs for developing an adaptive treatment strategy
Daniel Almirall1, Scott N Compton, Moira A Rynn
11 Survey Research Center, Institute for Social Research, University of Michigan , Ann Arbor, Michigan.
Journal of Child and Adolescent Psychopharmacology
|October 23, 2012
Summary
Sequential Multiple Assignment Randomized Trials (SMART) offer a more efficient and cost-effective alternative to standard discontinuation trials for childhood psychiatric disorders. This innovative design provides richer data for treatment duration and sequence questions.
Area of Science:
- Clinical Psychology
- Psychiatric Research
- Biostatistics
Background:
- Evidence-based practices for childhood psychiatric disorders require understanding long-term treatment effects beyond acute phases.
- Discontinuation trials traditionally assess treatment duration and maintenance strategies after initial acute treatment success.
- Sequential Multiple Assignment Randomized Trials (SMART) are emerging as a method to inform complex clinical decision-making.
Purpose of the Study:
- To illustrate the relationship between SMART designs and standard discontinuation trials.
- To demonstrate how SMART designs can address additional clinical questions using similar trial resources.
- To compare the efficiency and data yield of SMART versus standard discontinuation trials.
Main Methods:
- Utilized the Child/Adolescent Anxiety Multimodal Study (CAMS) as a case example.
- Compared the standard discontinuation trial design with the proposed SMART design.
- Analyzed the potential for SMART to answer broader research questions.
Main Results:
- SMART designs can be slightly modified from standard discontinuation trials to yield high-quality data.
- SMART designs address a wider range of questions, including treatment duration impacts.
- SMART designs are more efficient, less costly, and may offer more representative treatment comparisons.
Conclusions:
- Mental health researchers should consider SMART designs over discontinuation trials for studying post-acute treatment effects.
- SMART designs facilitate research on individualized treatment sequences and rescue treatments for relapse.
- SMART designs enhance the ability to answer critical questions in pediatric psychiatric treatment research.
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