期刊
PSYCHOLOGY AND AGING
卷 37, 期 1, 页码 43-50出版社
AMER PSYCHOLOGICAL ASSOC
DOI: 10.1037/pag0000653
关键词
good clinical practice; rigor; reproducibility; transparency; ACTIVE trial
资金
- National Institute on Aging [U01 AG014260, U01 AG014282, U01 AG014263, U01 AG014289, U01 AG014276, R01 AG056486, T32 AG020499]
- National Institute of Nursing Research [U01 NR004508, U01 NR004507]
Clinical trials are guided by GCP principles to enhance rigor, reproducibility, and transparency in scientific research. Single-laboratory studies can mimic GCP principles used in large clinical trials.
Clinical trials are governed by principles of good clinical practice (GCP), which can strengthen the achievement of rigor, reproducibility, and transparency in scientific research. Rigor, reproducibility, and transparency are key for producing findings with greater certainty. Clinical trials are closely supervised, often by a clinical trial coordinating center, data safety and monitoring board, and a funding agency, with policies that are a manifestation of GCP and support rigor, reproducibility, and transparency. The multisite Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study is an example clinical trial of relevance to a psychology and aging audience that utilized many protocols that can be applied to single-laboratory designs, including a manualized protocol with accompanying scientific rationale, predefined analysis plans, standardization of procedures across field sites, assurance of competence of study staff in study procedures, transparent coding/entry/transmittal of data, regular quality assurance, and open publication of data. Despite substantial resource discrepancies between the two, single-laboratory studies can model the GCP principles utilized in large clinical trials to provide an excellent foundation for rigor, reproducibility, and transparency.
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