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

Vollmer, Sara H.; Howard, George

doi:10.1007/s11948-010-9244-0

Cited by 27 publications

(19 citation statements)

References 11 publications

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“…These false negative findings are labeled as type II errors. To maintain the balance between individual and collective ethics, the prefixed power is usually set at 80% to 90%. Consequently, approximately 10% to 20% (ie, the type II error rate) of the trials are expected to fail due to lack of efficacy even when the treatment is effective and when assumptions/estimations adopted in the sample size computations are correct.…”

Section: Fair Evaluation Of the Failure Rate And Damagementioning

confidence: 99%

Empowering phase II clinical trials to reduce phase III failures

Martini

2019

Pharmaceutical Statistics

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The large number of failures in phase III clinical trials, which occur at a rate of approximately 45%, is studied herein relative to possible countermeasures. First, the phenomenon of failures is numerically described. Second, the main reasons for failures are reported, together with some generic improvements suggested in the related literature. This study shows how statistics explain, but do not justify, the high failure rate observed. The rate of failures due to a lack of efficacy that are not expected, is considered to be at least 10%. Expanding phase II is the simplest and most intuitive way to reduce phase III failures since it can reduce phase III false negative findings and launches of phase III trials when the treatment is positive but suboptimal. Moreover, phase II enlargement is discussed using an economic profile. As resources for research are often limited, enlarging phase II should be evaluated on a case-by-case basis. Alternative strategies, such as biomarker-based enrichments and adaptive designs, may aid in reducing failures. However, these strategies also have very low application rates with little likelihood of rapid growth.

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Section: Fair Evaluation Of the Failure Rate And Damagementioning

confidence: 99%

Empowering phase II clinical trials to reduce phase III failures

Martini

2019

Pharmaceutical Statistics

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“…Shore (2006) criticizes the Belmont Report for not taking into account more appropriate aspects of ethical and moral conduct and behaviour such as political, governance, ethnic, cultural, gender, economic, language and environmental considerations. All of these aspects are under constant scrutiny as is the question of how they should be weighted or prioritised (Vollmer 2010).…”

Section: Ethical Principlesmentioning

confidence: 99%

University research ethics clearances: Safety nets, or a false sense of legal immunity?

Beckmann

2017

SAJHE

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Ethics reviews are major events in the life of a researcher at a university. Ethics clearances for research projects are time consuming and sometimes slow down research progress. Because of the serious implications of unethical research conduct it follows that ethics committees should review research project applications meticulously and critically. They should attempt to ensure that, in all projects that are approved, the human respondents and participants are protected and suffer no harm that could have been prevented. do not reflect an ability to give due consideration to the legal implications of the granting of ethics clearance. Very little attention seems to be given to alerting researchers and clearance-granting agencies to the legal risks to which they might be exposed during and subsequent to the conducting of a research project.This article investigates the protection that ethics review protocols (particularly in the human sciences at higher education institutions) offer researchers and their institutions against legal ramifications emanating from research projects where participants do suffer harm. In investigating the protection I examine the terms 'ethics', 'morality' and the 'law' and relate them to ethics clearance applications. I also discuss some possible legal consequences of unethical conduct emanating from research.The main finding is that research ethics protocols may offer less protection against legal implications of ethical misconduct than would generally be thought to be the case. There seems to be a need to raise awareness of possible legal consequences associated with research malpractices. There also seems to be a need for and guidelines and training that would facilitate such awareness.

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“…Codification of the standards and ethical requirements used in experimental surgery can be found in documents such as the Nuremberg code, the Declaration of Helsinki, and the Belmont Report. [6][7][8] Thus, the patient must understand the significant uncertainty that is associated with any experimental procedure.…”

Section: Ethical Considerationsmentioning

confidence: 99%

Facial transplantation: a review of ethics, progress, and future targets

Edwards¹,

Mathes²

2011

TRRM

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The surgical history of transplantation in the modern era begins in 1956 with the successful transplantation of a kidney between identical twins. Since then the field of transplantation has seen remarkable advancements in both surgical techniques and our understanding and ability to manipulate the immune response. Composite tissue allotransplantation involves the transplantation of any combination of vascularized skin, subcutaneous tissue, blood vessels, nerves, muscle, and bone. Orthotopic hand transplantation is considered the first clinical example of CTA and has seen success at many different centers worldwide. Facial allotransplantation is a recent development in the field of CTA and the first successful case was performed as recently as November 2005. Since then there have been a number of successful facial transplants. The purpose of this paper is to examine some of the issues surrounding facial transplantation including the complex ethical issues, the surgical and clinical issues, cost and administrative issues, and future directions for this new, exciting, and controversial field.

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

Cited by 27 publications

References 11 publications

Empowering phase II clinical trials to reduce phase III failures

Empowering phase II clinical trials to reduce phase III failures

University research ethics clearances: Safety nets, or a false sense of legal immunity?

Facial transplantation: a review of ethics, progress, and future targets

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