Key result
NHLBI clinical trial design and monitoring concepts remain in use 25 years after implementation.
Why the study?
Many clinical trial design and monitoring concepts used today in the NHLBI were implemented 25 years ago, but their historical development and impact have not been fully described.
Key points are not available for this paper at this time.
Design
Review of NHLBI clinical trial design and monitoring concepts over 25 years
Early NHLBI designs remain relevant for trial oversight; extends historical precedent while leaving open refinements for contemporary methodologies.
Although newer techniques and procedures have been developed, many of the clinical trial design and monitoring concepts used today in the NHLBI were implemented 25 years ago. Among these are the organizational structure of multicentre trials and the use of an independent data monitoring committee. Examples of data monitoring committee discussions and decisions are provided.
No takes yet. Share an insight, caveat, or question.
Lawrence M. Friedman (1993) studied this question. NHLBI clinical trial design and monitoring concepts, including independent data monitoring committees and multicentre structures, were implemented 25 years ago and remain in use today.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: