Statistical Power, the Belmont Report, and the Ethics of Clinical Trials

@article{Vollmer2010StatisticalPT,
  title={Statistical Power, the Belmont Report, and the Ethics of Clinical Trials},
  author={Sara H. Vollmer and George Howard},
  journal={Science and Engineering Ethics},
  year={2010},
  volume={16},
  pages={675-691}
}
Achieving a good clinical trial design increases the likelihood that a trial will take place as planned, including that data will be obtained from a sufficient number of participants, and the total number of participants will be the minimal required to gain the knowledge sought. A good trial design also increases the likelihood that the knowledge sought by the experiment will be forthcoming. Achieving such a design is more than good sense—it is ethically required in experiments when… 
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References

SHOWING 1-10 OF 12 REFERENCES
Ethical considerations in clinical trials
TLDR
It is concluded that problems of justice arise not only of the vulnerability of patients in VA hospitals hut also of the loss of the physician‐patient relationship in an RCT, and the values and preferences of the subjects should be taken into account in determining what information might be material.
Statistical power, sample size, and their reporting in randomized controlled trials.
TLDR
The pattern over time in the level of statistical power and the reporting of sample size calculations in published randomized controlled trials (RCTs) with negative results is described and few trials discussed whether the observed differences were clinically important.
What are the effects of the fifth revision of the Declaration of Helsinki?
TLDR
The World Medical Association's fifth revision of the Declaration of Helsinki strives to strike a balance between ensuring high ethical standards and retaining sufficient sensitivity to local circumstances to avoid thwarting research with bureaucracy.
Reporting of power and sample size in randomized controlled trials.
TLDR
A large sample of articles from important journals for sample size adequacy was reviewed, noting that most trials with negative results did not have sample sizes large enough to detect a 25% or a 50% relative difference and that few trials discussed whether the observed differences were clinically important.
The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials.
TLDR
Concern for the probability of missing an important therapeutic improvement because of small sample sizes deserves more attention in the planning of clinical trials.
When experiments go wrong: the U.S. perspective.
  • A. Capron
  • Medicine
    The Journal of clinical ethics
  • 2004
TLDR
The system of local oversight is only partially effective in improving the design of experiments and the consent process in light of "unexpected (adverse) results," and it is shown that the U.S. system is far from perfect in responding when research goes wrong.
A power primer.
  • J. Cohen
  • Mathematics
    Psychological bulletin
  • 1992
TLDR
A convenient, although not comprehensive, presentation of required sample sizes is providedHere the sample sizes necessary for .80 power to detect effects at these levels are tabled for eight standard statistical tests.
The Declaration of Helsinki: an update on paragraph 30
Research on human subjects is governed by a large number and wide variety of codes and policies worldwide. In Canada, the Tri-Council Policy Statement[1][1] must be adhered to by individuals and
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.
TLDR
This resolution is to be adopted by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013 on the theme of human rights and democracy.
Statistics, a foundation for analysis
A runaway binding assembly for skis comprising an elongated member, having opposing ends and means for connecting one end of said elongated member to a ski with the member in a desired normal
...
1
2
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