Smart Start - Designing Powerful Clinical Trials Using Pilot Study Data.
NEJM Evid
; 3(2): EVIDoa2300164, 2024 Feb.
Article
en En
| MEDLINE
| ID: mdl-38320487
ABSTRACT
BACKGROUND:
Digital health interventions may be optimized before evaluation in a randomized clinical trial. Although many digital health interventions are deployed in pilot studies, the data collected are rarely used to refine the intervention and the subsequent clinical trials.METHODS:
We leverage natural variation in patients eligible for a digital health intervention in a remote patient-monitoring pilot study to design and compare interventions for a subsequent randomized clinical trial.RESULTS:
Our approach leverages patient heterogeneity to identify an intervention with twice the estimated effect size of an unoptimized intervention.CONCLUSIONS:
Optimizing an intervention and clinical trial based on pilot data may improve efficacy and increase the probability of success. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT04336969.)
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Bases de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
NEJM Evid
Año:
2024
Tipo del documento:
Article