[Placebo-controlled trials in schizophrenia].
ABSTRACT Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials.
The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients.
Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted.
Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials.
We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow-up procedures for the study as determined by the local Helsinki Committee; and appointment of a supervisory mechanism by the administration of the medical institution where the study is being performed.
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ABSTRACT: The Trial Criteria in Schizophrenia Working Group was convened in November 2007 to define consensus criteria for clinical trials in patients suffering from acute schizophrenia with special focus on placebo-controlled trials and withdrawal conditions. Clinical trials involving patients give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective treatment regimens or placebo. The complexity of the problem increases when dealing with mentally ill patients. The Working Group's criteria are thought to cover different aspects important in conducting clinical trials namely to ensure the patient's safety, to present criteria that would allow the ethics committees to agree to the proposed criteria and to enable the possibility to reasonably conduct and ensure comparable quality of clinical studies in acutely ill patients with schizophrenia. To furthermore counteract current inconsistencies, these criteria should be evaluated using standardized rating scales applying established cut-off criteria. The developed trial criteria cover inclusion and exclusion criteria as well as withdrawal criteria due to non-response or worsening of symptoms.European Archives of Psychiatry and Clinical Neuroscience 07/2011; 262(2):151-5. · 2.75 Impact Factor
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ABSTRACT: Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study--first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed.Kennedy Institute of Ethics journal 03/2010; 20(1):75-98. · 1.21 Impact Factor
Article: Ethics and research in psychiatry[Show abstract] [Hide abstract]
ABSTRACT: This article reviews the psychiatric research ethics literature of the past year, including papers that cover a broad range of ethical issues arising throughout the research process. Although informed consent is an enduring concern, important issues such as the choice of study design, participant recruitment, and publication are also considered.International Review of Psychiatry 07/2009; 10(4). · 1.80 Impact Factor