Placebo-controlled trials and the Declaration of Helsinki

Lewis, John A.; Jönsson, Bertil; Kreutz, Gottfried; Sampaio, Cristina; Zwieten-Boot, Barbara van

doi:10.1016/s0140-6736(02)08277-6

Cited by 85 publications

(50 citation statements)

References 10 publications

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“…The procedures followed were in compliance with the ethical standards of the institutional committees on human experimentation and with the Helsinki Declaration of 1964, amended Tokyo 1975, Venice 1983, and Hong Kong 1989. 22 The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) 23 was used to evaluate cognitive function. Efficacy evaluations (ADAS-Cog score, mean change from baseline) were completed at baseline, weeks 12, 18, and 26, or within 24 hours of the last dose of study medication in patients who discontinued treatment early.…”

Section: Patient Populationmentioning

confidence: 99%

Analysis of Outcome in Retrieved Dropout Patients in a Rivastigmine vs Placebo, 26-Week, Alzheimer Disease Trial

Farlow¹,

Potkin²,

Koumaras³

et al. 2003

Arch Neurol

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Background: Treatment with cholinesterase inhibitors improves cognition in patients with Alzheimer disease (AD). In studies designed with a washout period at the end of the study, after treatment with a cholinesterase inhibitor is discontinued, the cognitive benefits of therapy are no longer apparent following washout. The rivastigmine trials discussed in this article were not designed with a posttreatment washout period at the end of the study. Therefore, to evaluate the effect of discontinuing treatment, we analyzed the retrieved dropout (RDO) population. Objective: To evaluate the change in cognition (at week 26 vs baseline) observed in patients from 3 large clinical trials of AD who prematurely discontinued treatment with placebo or rivastigmine. Design and Methods: Eligible patients with AD (Mini-Mental State Examination [MMSE] score, 10-26, inclusive) were enrolled in 1 of three 26-week, double-blind, placebo-controlled studies (Novartis US Pivotal [doserange] Trial , US fixed-dose study, and a Global Pivotal [dose-range] Trial) that compared rivastigmine therapy with placebo. Patients who discontinued study participation (for any reason) (considered to be the RDO population) were encouraged to return for their scheduled week 26 efficacy evaluations. Effects on cognition were assessed using the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog). Results: The results for the Novartis US Pivotal Trials and for the 3 studies combined (Novartis studies B352,

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Section: Patient Populationmentioning

confidence: 99%

Analysis of Outcome in Retrieved Dropout Patients in a Rivastigmine vs Placebo, 26-Week, Alzheimer Disease Trial

Farlow¹,

Potkin²,

Koumaras³

et al. 2003

Arch Neurol

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“…These conditions are specified in the ICH E10 [18]. [22]. Furthermore, the WMA was blamed for being the 'ethical police', and that they lacked insight into the complex situation in Africa in relation to their comments on the zidovudine trials [23].…”

Section: Discussionmentioning

confidence: 99%

Ethical dilemmas in research quality assurance

Lucas¹

2005

Qual. Assur. J.

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SummaryIn this essay three examples of ethical dilemmas in research quality assurance are presented. For one of the examples, dealing with the use of placebo control groups in bio-medical research on humans, the balance between ethical and scientific considerations will be evaluated on basis of a critical review of the applicable standards and/or regulations, such as the Declaration of Helsinki and the current Good Clinical Practice (GCP) regulations.

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“…In considering a control group for a clinical trial, judicious use of a concurrent placebocontrolled arm presents one of several options when designing the trial [30][31][32]. Differing positions by regulators and ethics committees are particularly relevant to MRCT.…”

Section: Placebo-controlled Clinical Trialsmentioning

confidence: 99%

Ethical considerations in industry‐sponsored Multiregional clinical trials

Ibia

Binkowitz

Saillot

et al. 2010

Pharmaceutical Statistics

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During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider.

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Placebo-controlled trials and the Declaration of Helsinki

Cited by 85 publications

References 10 publications

Analysis of Outcome in Retrieved Dropout Patients in a Rivastigmine vs Placebo, 26-Week, Alzheimer Disease Trial

Analysis of Outcome in Retrieved Dropout Patients in a Rivastigmine vs Placebo, 26-Week, Alzheimer Disease Trial

Ethical dilemmas in research quality assurance

Ethical considerations in industry‐sponsored Multiregional clinical trials

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