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PubMedDate not supplied

Adaptation of the clinical trials directive: recommendations on the contents of a dossier for the request for authorisation of the first trials in human subjects.

The European Directive on clinical trials of medicinal products will fall within the scope of the legislation of Member States on 1 May 2004. In France, this adaptation will be carried out by a public health bill concerning, among other things, the reform of the current Huriet-Sérusclat law, and by means of regulations. For trials concerning the initial administration of a product to human subjects, the group suggested the following recommendations: In French texts, to include a deadline of 30 days for the initial authorisation by the competent authority (Afssaps [Agence française de sécurité sanitaire des produits de santé]). To maintain an observed deadline of 20 days (35 official days) for the decision of the Ethics Committee (EC) [Committee for the Protection of Persons (CPP)]. To obtain a more specific evaluation of the pharmaceutical dossier of the investigational medicinal product (IMP) from the competent authority. To provide both bodies with nonclinical and possibly clinical data concerning the IMP information of the participants and their consent. To follow the recommendations posted on the Afssaps website for the entire IMP dossier. To submit a protocol under the International Committee on Harmonisation (ICH) E6 format adapted for phase I and, possibly as a separate document, justification of a certain number of points (a total of ten) that are more specific to this trial phase to facilitate and improve the document review while also providing the expected guarantees. To limit the 'substantial' amendments to those provided for in the European guidelines. To break the blind for every serious event reported to the sponsor by the investigator, and report to the competent authority any serious adverse event related to the IMP or to the trial or without documented cause, while keeping ECs and investigators informed. Furthermore, certain points concerning the authorisations for packaging, labelling and dispensing of the batches of medicinal products for clinical trials will need to be specified for these early studies. All these recommendations are intended to help promote the development of studies involving the initial administration of medicinal products in France.

Clinical Trials as Topic↗
PubMed2006

[Clinical research ethics in respiratory medicine].

Clinical research plays an increasingly strong role in the development of respiratory medicine. Familiarity with issues that affect research on human subjects is therefore essential, particularly so with regard to the conduct of clinical trials of medical with medications. This paper begins with a brief introduction to the ethics of clinical research. We highlight the importance of directives on ethics and the need to understand and comply with them when any type of experiment is conducted on humans. Following is a brief description of historical codes of bioethics and an account of their underlying principles, origins, and consequences. Finally, we discuss Spanish Royal Decree 23/2004 of February 6, 2004 which came into force on May 1 that year; we outline its general principles and analyze 2 types of problem that have emerged: those that result from the article requiring a single central opinion and those of investigators who act independently of the pharmaceuticals industry. The situation of clinical research in respiratory medicine at our hospital is then described. Finally, the 7 requirements of ethical research listed by Emanuel and colleagues are proposed as a tool that pneumologists can use to analyze and assess whether or not a specific trial meets minimum ethical requirements.

Biomedical Research↗
PubMed1992

[Ethics in researcher-research promotor relations].

The performance of Clinical Trials can give rise to ethical problems especially between the researchers and the promotors but sometimes also with those who are in charge of the publication of results. Medicine and the Pharmaceutical Industry must face up to the need to try and save a marriage that is not only one of convenience but most of all lifesaving. The Industry supports the major slice of Postgraduate and Continuous Medical Education with its main goal being the promotion of its products. The Educational component we doctors are interested in is usually secondary for the Industry. A Clinical Trial comprises several steps beginning with the design of its protocol, its discussion by promotors and scientists and its performance where researchers, monitors, and official auditors have the main role. The analysis of the results should be handled by official boards unrelated to either promotors or researchers and their publication should be undertaken by a reliable Medical Journal whose editorial board would authenticate the accomplished scientific work. Ethical Commissions, both national and institutional, have a unique role in the analysis and authorization of Clinical Trials. Before any drug is put onto the pharmaceutical market, it is obligatory that the four successive phases of Clinical Pharmacological Studies be accomplished. A common problem we usually face is to differentiate a Phase IV from just a Promotional Trial. When a Promotional Trial is done, all the clinical goals of investigation have already been reached. The objectives of Promotional Trials are merely related to the Marketing Department and disregard any scientific purposes. Promotional Trials should not involve Universities, Hospitals and other official Institutions.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMed2001

Human in vivo studies of non-pharmaceutical products.

Two principal types of human in vivo studies with non-pharmaceuticals can be distinguished: (1) human metabolism studies are used for identification of target metabolites which can subsequently be used in biological monitoring studies. Furthermore, they allow extrapolation from excretion of metabolite(s) to exposure to the parent compound on the basis of an understanding of human pharmacokinetics. (2) Pharmacodynamic or effect studies are restricted to the study of acute and inherently reversible changes and are most likely to improve risk assessment in the following areas: neurobehavioural effects (e.g. alcohol, organic solvents), alterations in biochemical markers (e.g. cholinesterase inhibition following organophosphate exposure) and topical effects (e.g. skin irritancy). Ethical considerations are of prime importance and, as a minimum, any human study must comply with the principles of the Declaration of Helsinki. The protocol should include scientifically sound objectives, a justification of subject numbers, a formal risk-benefit analysis and provisions for appropriate ethical review. The welfare of the individual participating in the study must be paramount. Informed consent has to be obtained and subjects must be free to withdraw from the study at any time. Compensation should be given for the inconvenience of participating in the study, but never for undergoing risk. Provided these conditions are met, human volunteer studies can be a powerful tool in risk assessment and risk management of exposure to non-pharmaceutical products.

Ethics↗
PubMed2003

Bioethics, vulnerability, and protection.

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. The type of multinational research likely to raise the most ethical concerns is that in which the investigators or sponsors are from a powerful industrialised country or a giant pharmaceutical company and the research is conducted in a developing country. Second is the situation of women, who are made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. In the face of cultural values and practices, or governmental policies, these women suffer serious consequences for their health and even lives. Examples are provided, and it is suggested that in some cases vulnerable individuals can be harmed but not exploited. On the positive side, recent developments reveal a new awareness of exploitation and efforts to enhance the ability of developing countries to protect themselves and their citizens from exploitation at the hands of powerful sponsors of research. In addition, human rights principles are increasingly being used to monitor the actions (or inaction) of governments regarding women's reproductive rights and vulnerability with respect to HIV/AIDS, and to take remedial actions.

Circumcision, Female↗
PubMed1998

[Good clinical practice].

Good clinical practice is the pattern of international standards to assure ethical and scientific quality in the design, conduction and report of studies that involve human beings. These standards are applied in pharmaceutical research, since they came out as regulations to register new medications. Nowadays, they are accepted as standard procedures in clinical research. They are enforced in developed countries since more than a decade and are currently being implemented in Latin America, thanks to an initiative of the pharmaceutical industries. The saturation and high costs of clinical research in Europe and United States, render Latin America as a potential region to conduct clinical studies. FDA, Europe and Japan accept data from abroad, if the studies are conducted following the norms of good clinical practice. It is therefore important that Chilean research centers and researchers become familiar with these norms and be prepared for their implementation.

Clinical Protocols↗
PubMed2006

Clinical trials research in pediatrics: strategies for effective collaboration between investigator sites and the pharmaceutical industry.

There is a paucity of clinical trials work in children, which leads to the frequent use of off-label and unlicensed medications in this very vulnerable group. Clinical trials work in children may be more difficult than in adults, and there are certainly ethical constraints. However, the differences between adults and children, and at different stages of childhood development, mandate strategies to improve this situation rather than continually relying on extrapolation from adult studies. Therefore, new strategies have to be established between the pharmaceutical industry and pediatric centers to facilitate effective trials work. These must be based on a clear and mutual understanding of the differences between working with children and adults. Disease phenotypes may be completely different in children; for example, wheeze in infants is not miniature adult asthma. Clinical trial design must be practical, and a trial is more likely to succeed if a simple design is utilized, with minimal interference with school work and the work of carers. The new UK initiative, 'Medicines for Children', should go a long way towards addressing the problem, and increase the evidence base for the utilization of medications in pediatric practice.

Biomedical Research↗
PubMedDate not supplied

Counterfeit pharmaceuticals: current status and future projections.

OBJECTIVES: To examine the problem of counterfeit drugs and its effects around the world, to consider the likely directions the problem will take, and to propose options for controlling or mitigating the problem. DATA SOURCES: Recently published clinical literature identified through review of articles abstracted at MEDLINE. Search terms were counterfeiting, counterfeit drugs, substandard drugs, fake drugs, world counterfeiting, and counterfeit pharmaceuticals. Further information was abstracted from an array of informational sources, including magazines such as Business Week, newspapers such as the International Herald Tribune, National Public Radio news reports, pharmaceutical company press releases, and information from the World Health Organization. STUDY SELECTION: Multiple reviewers were used to retrieve relevant and current data. DATA EXTRACTION: Relevant data were extracted independently by multiple reviewers. DATA SYNTHESIS: Traditionally, the problem of counterfeit pharmaceuticals has been limited to developing nations in Asia and Africa. Now, drug counterfeiting is rapidly becoming a worldwide concern, and counterfeit drugs are reaching the U.S. market. This article defines the problem of counterfeit drugs in its many forms and discusses the extent of the problem, with particular attention to the respective rates of counterfeiting across the globe and the origins of counterfeit drugs. CONCLUSION: Technologic advances have worsened the counterfeit drug problem. Because drug counterfeiting is a worldwide concern, worldwide action is needed to combat the problem.

Consumer Product Safety↗
PubMed2005

Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men.

Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures.

Female↗