Ethical issues, clinical trials

In most cases, the competent ethics committee for clinical tried approved is a central one. Until the new Decree of the Minister of Hecdth on clinical trials is issued, regional ethics committees are responsible for certain humcin phase III trials. This situation may be changed by the Decree. Updated NIP guidelines or information clarifying the recent situation are always available in English. 

The review of clinical drug trials by IRBs raises a number of interesting and difficult issues. These relate to the origin and sponsor of the proposed trial, the nature of the institution the IRB serves, and the manner in which the norms for determining ethical conduct in clinical trials can be applied to specific trials. 

The Ethics Committee shall give its opinion, before a clinical trial commences, on any issue requested. 

The sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and inasmuch as the competent authority of the Member State concerned has not informed the sponsor of any grounds for non-acceptance. The procedures to reach these decisions can be run in parallel or not, depending on the sponsor. 

While the issue of the ethical conduct of clinical trials in pediatric psychopharmacology is addressed comprehensively elsewhere in this book, it is important to present an FDA perspective on this important matter. It is also important to have the issue of ethics discussed in the context of the scientific needs for trials presented to the FDA in support of new drug applications. These trials must be adequate and well-controlled (U.S. Department of Health and Human Services, 2001). What this requirement essentially means is that, in order to support an efficacy claim, the trials must be interpretable and must be able to document efficacy. For treatments that are intended to improve symptoms, as is almost always the case for psychotropic drugs, placebo-controlled trials are the usual standard. This is especially true when there is a substantial failure rate in placebo-controlled trials for the drugs known to work in a particular therapeutic area, as again is the case for most psychotropic drugs. Where that is true,... 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

Each study component has an ethical aspect. The ethical aspects of a clinical trial cannot be separated from the scientific objectives. Segregation of ethical issues from the full range of study design components demonstrates a flaw in understanding the fundamental nature of research involving human subjects. Compartmentalization of ethical issues is inconsistent with a well-run trial. Ethical and scientific considerations are intertwined (p. 4). 

An important issue on multiauthored papers is deciding who should be an author (single-authored empirical reports are extremely rare since contemporary clinical research typically requires considerable collaboration). Since many people are involved in the execution of a clinical trial, appropriate criteria are needed to decide on those who will be listed as authors. As in so many instances in this book, both scientific and ethical issues need to be addressed. It is unethical for someone who should not be an author to expect to be so. 

The Three Rs principle has been and still is a useful tool for engaging all stakeholders in the development of a common strategy in relation to animal experimentation. The establishment of a Three Rs principle pertaining to human experiments and thereby the introduction of a new and useful tool for engaging different stakeholders in developing a common strategy in relation to the future use of human subjects may help to solve some of the key ethical issues relating to clinical trials. 

The multicenter trial approved procedure is described herein. First, the pharmaceutical sponsor submits to the SIPCDE all relevant documentation in accordance with the Instruction. .. (See Appendix 6), which requires a different set of documentation in comparison to product registration dossiers. The documentation is reviewed by the SIPCDE s specialized department and the Cliniced Trials Department, as well as by specialized SPLC commissions, after which they are forwarded for the SPLC s scientific and ethics review. The SPLC then issues a resolution which is issued to the applicant and the SCA. The procedure takes 3 months maximum (in case extra information is needed for approval) and normally lasts 1 month. 

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