Embedding clinical interventions into observational studies.
Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed.
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Related Subject Headings
- Research Design
- Public Health
- Observational Studies as Topic
- Humans
- General Clinical Medicine
- Epidemiologic Studies
- Cost-Benefit Analysis
- Cohort Studies
- Clinical Trials as Topic
- 42 Health sciences
Citation
Published In
DOI
EISSN
Publication Date
Volume
Start / End Page
Location
Related Subject Headings
- Research Design
- Public Health
- Observational Studies as Topic
- Humans
- General Clinical Medicine
- Epidemiologic Studies
- Cost-Benefit Analysis
- Cohort Studies
- Clinical Trials as Topic
- 42 Health sciences