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Good clinical practice improves rigor and transparency: Lessons from the ACTIVE trial.
Brad P Taylor1, George W Rebok2, Michael Marsiske1
1Department of Clinical and Health Psychology, University of Florida.
Psychology and Aging
|February 3, 2022
Summary
Good Clinical Practice (GCP) principles enhance rigor, reproducibility, and transparency in scientific research. Large clinical trials like the ACTIVE study offer models for single-laboratory studies to improve research integrity.
Area of Science:
- Gerontology
- Clinical Psychology
- Cognitive Science
Background:
- Good Clinical Practice (GCP) principles are essential for ensuring rigor, reproducibility, and transparency in scientific research.
- Effective oversight in clinical trials, including data safety and monitoring boards, reinforces these principles.
- The multisite Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study exemplifies robust research protocols.
Purpose of the Study:
- To highlight how Good Clinical Practice (GCP) principles can enhance scientific rigor, reproducibility, and transparency.
- To demonstrate the applicability of large clinical trial protocols to single-laboratory studies.
- To provide a framework for improving the integrity of psychological and aging research.
Main Methods:
- Examining protocols from the multisite Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study.
- Identifying key GCP principles: manualized protocols, predefined analysis plans, standardization, staff training, transparent data handling, quality assurance, and open data publication.
- Analyzing the adaptability of these protocols for single-laboratory research designs.
Main Results:
- GCP principles, as demonstrated in the ACTIVE study, significantly bolster research rigor, reproducibility, and transparency.
- Protocols such as manualization, standardization, and transparent data management are transferable to smaller, single-laboratory settings.
- Adoption of these principles can improve the certainty and reliability of findings in psychology and aging research.
Conclusions:
- Single-laboratory studies can effectively adopt GCP principles from large clinical trials to enhance research integrity.
- Implementing standardized protocols and transparent data practices is crucial for robust scientific findings.
- The ACTIVE study serves as a valuable model for improving rigor, reproducibility, and transparency across diverse research settings.
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