ELI5 Series: What is Clinical Effectiveness?
Kefauver Harris Amendment
What is Clinical Effectiveness?
How Does Effectiveness Differ from Efficacy?
How is Effectiveness Determined?
Randomized Controlled Trial (RCT)
The Future of Effectiveness Research
Issues Motivating the Discussion
(from Institute of Medicine Roundtable on Value & Science-Driven Health Care, http://www.ncbi.nlm.nih.gov/books/NBK51004/)
- Need for substantially improved understanding of the comparative clinical effectiveness of healthcare interventions.
- Strengths of the randomized controlled trial muted by constraints in time, cost, and limited applicability.
- Opportunities presented by the size and expansion of potentially interoperable administrative and clinical datasets.
- Opportunities presented by innovative study designs and statistical tools.
- Need for innovative approaches leading to a more practical and reliable clinical research paradigm.
- Need to build a system in which clinical effectiveness research is a more natural by-product of the care process.
References & Resources
"Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products"
http://www.ncbi.nlm.nih.gov/books/NBK44024/
Beyond the intention-to-treat in comparative effectiveness research
Clinical Trials
http://www.ncbi.nlm.nih.gov/books/NBK51004/
External validity of randomised controlled trials: "To whom do the results of this trial apply?
Lancet
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