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Results for “Ethical Review”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 19 recordsLinked to original sources
PubMed1977

Ethical review in the pharmaceutical industry.

1. There seems no reason why clinical pharmacology studies conducted within the pharmaceutical industry should be exempt from the requirement of ethical review, and independent review in this situation reduces the vulnerability of the company and its employees, in addition to serving its primary function of protecting the volunteer subjects. 2. Experience within one company has shown that independent ethical review need not seriously influence the pace of research. 3. It is important that such committees should be seen to be independent and competent.

Drug Evaluation↗
PubMed1975

Safeguards for healthy volunteers in drug studies.

Safeguards for healthy volunteers in drug studies have not been as strict as those involving patients. The shortcomings include the lack of surveillance over the scientific validity of the protocol and its ethical review, and over the financial inducements to volunteers. Recruitment is open to abuse because the volunteers may have some allegiance to the investigators. There is an urgent need to institute checks on these aspects. Most important, however, is the lack of legal safeguards for volunteers taking part in research done outside the pharmaceutical industry. The suggested procedure for obtaining consent, for health checks, and for providing compensation can be equitable to all concerned, and yet not restrict initiative, nor curtail research aims.

Biomedical Research↗
PubMed1977

Peer review and professional ethics.

The author points out that the medical profession, fiscal intermediaries, and government agencies have not fully informed the public of the nature and extent of peer review. He provides guidelines for physicians and committees of peers participating in peer review and suggests that review of professional ethics be incorporated into the review of the quality, cost, quantity, and availability of medical services.

Codes of Ethics↗
PubMed2026

Risk-Benefit of Phase 2 Monotherapy Trials in Adult Solid Cancers: A Systematic Review and Meta-Analysis.

Phase 2 (and phase 1 dose expansion, which we label phase 2 for the purposes of this study) cancer trials are the first direct tests of a new drug's efficacy. Because efficacy evidence is lacking, the therapeutic status of drug administration during ethical review is uncertain. We compared the efficacy and safety of cancer monotherapies in phase 2&#xa0;with phase 3, where clinical equipoise underwrites a therapeutic status for drug administration. In this systematic review and meta-analysis, we searched Clinicaltrials.gov for phase 2 and 3 investigational monotherapy drug trials in six solid malignancies, with primary completion dates 2015-2020, inclusive. Two independent reviewers completed data extraction. Effects were estimated using an inverse-variance weighted random-effects model meta-analysis of proportions using the R package meta. We analyzed 130 phase 2 and 52 phase 3 trial arms, enrolling 6665 and 18,694 patients. The pooled objective response rate was 7% (95% CI 5%-11%) in phase 2 versus 24% in phase 3 (95% CI 17%-31%; p&#x2009;<&#x2009;0.0001). The median PFS and OS were shorter in phase 2 compared to phase 3 (3.23 vs. 5.43&#x2009;months, p&#x2009;<&#x2009;0.0001; 9.46 vs. 14.44&#x2009;months, p&#x2009;=&#x2009;0.0001). The pooled rate of drug-related grade 3-4 adverse events was 30% (95% CI 23%-37%) in phase 2 and 25% (95% CI 19%-32%) in phase 3. Monotherapies delivered in phase 2 cancer trials present diminished risk-benefit compared with phase 3 and align with historic estimates for phase 1. Though there may be exceptions, risks for drug administration in phase 2 should generally be justified by appeals to research rather than therapeutic value.

Humans↗
PubMed1975

The inherent paradox of clinical trials in psychiatry.

The authors sum up the central issue of ethics in the conduct of controlled clinical trials in these two paradoxes: 'first, it is unethical to use treatment the efficacy of which has not been examined scientifically; second, it is also unethical to examine the efficacy of treatment scientifically.' In this paper they set out to demonstrate how these antithetical statements apply in controlled trials conducted in psychiatric patients. In such trials the problem of obtaining informed consent may be acute, but in these patients giving 'informed' consent might contribute to a further exacerbation of the illness. Nevertheless the problem cannot be evaded, and scientific judgments must be applied to treatment for it to be sound and improved for the further benefit of patients. These problems in the case of psychiatric controlled trials are a part of the methodology, and in Germany a new drug law has been drafted to attempt to clarify the issue. The authors briefly discuss its application, and its consequences if such a law were enacted. British psychiatrists have exactly the same problems to face but so far no attempts have been made to establish a legal framework.

Clinical Trials as Topic↗
PubMed1977

Federal constraints: earned or unearned?

The author discusses the evolution of federal constraints on medical, behavioral, and social science research. There has been only one court decision related to behavioral research and none in medical research. The burden of consent procedures can be lightened somewhat by careful consideration of the potential risks and nature of the research; questions are presented that can be used to determine whether constraints apply. The author notes that although there are good reasons for regulations in both behavioral and medical research, the appropriateness of current and proposed constraints is still a matter of debate.

Behavior↗
PubMed1978

Ethics in the practice of psychiatry--origins, functions, models, and enforcement.

The author points out that psychiatric ethics are coming under increasing critical scrutiny by psychiatrists and by those outside of the profession. On the basis of an examination of APA Ethics Committee records, he concludes that criticism of psychiatry's inability to police itself might have some merit but cautions that the critics might be expecting too much from a code of ethics, which has the job of sensitizing psychiatrists to an ethical way of professional life and helping sort out ethical conflicts. After outlining a number of the problems in the self-policing aspect of ethics, the author makes suggestions for their resolution.

Codes of Ethics↗