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PubMed1996

[Therapeutic trials in oncology. Legal aspects].

Therapeutic trials in the field of oncology regularly serve the dual purpose of expanding existing knowledge and meeting the doctor's obligation to provide medical care. Their objective is to check, modify or establish standards of treatment. In the form of clinical trials, they investigate the effects (efficacy, risks and other properties) of medicinal drugs. This applies both to new, as yet unapproved, drugs and also to drugs already in use, but now to be tested for an indication other than that for which they were originally approved. This applies to trials sponsored by the pharmaceutical industry and to studies not so sponsored. These clinical trials are subject to the regulations of pharmaceutical law (AMG), while others are assessed in accordance with the exemplary principles expressed in sec. 40 AMG. All therapeutic studies are required by pharmaceutical law or professional law to be reviewed by ethics committees (approval/advising). All such studies must comply with strict legitimation requirements of liability law. They may be carried out only when there has been a positive benefit/-risk assessment that promises results that are at least equal to those obtainable with standard treatment. Patient information requirements are strict and include the provision of information about alternative forms of treatment as well as about the absence of health insurance funding-where this applies- and the future funding of further treatment on termination of the study. Documentation obligations are extensive, and organizational requirements include the establishment of quality management. In the case of clinical trials, the conclusion of an insurance contract for the participants is mandatory, and in the case of other therapeutic studies urgently recommended. Therapeutic studies may be funded by statutory health insurance carriers within the framework of study regulations or quality assurance measures. This does not apply to clinical trials of drugs on behalf of the pharmaceutical industry.

Clinical Trials as Topic↗
PubMed2006

Bioethics activities in India.

The Indian Council of Medical Research formulates, coordinates and promotes biomedical research in India. In 1980, they formulated the first national ethical guidelines. They offer a number of different training programmes, from 1 day to 6 months. The council is developing a core curriculum for teaching bioethics, which would be applied uniformly in medical schools throughout the country. Drug development and ethics is also important in India, particularly now that the local pharmaceutical industry is expanding and so many drugs trials are outsourced to the country. The council is also very active in encouraging the development of ethics review committees.

Academies and Institutes↗
PubMed2004

Clinical pharmacology studies in UK Phase 1 units: an AHPPI survey 1999-2000.

AIMS: This study, conducted by the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI), was designed to determine the amount of Phase 1 activity in the UK in the period 1999-2000, the timelines involved for submissions to ethics committee and responses from ethics committees. METHODS: A questionnaire was completed by AHIPPI members from pharmaceutical companies with in-house phase 1 units, by Clinical Research Organizations (CRO's) and by academic centres. A few responses were also vailable from organisations that were not AHPPI members. Results were rendered anonymous and grouped by category. RESULTS: The response rate was > 98% and indicated that the vast majority of early drug research in humans is now CRO-based (82%). The total number of studies (as indicated by protocol numbers) was notably similar across the 2 years--629 in 1999 and 606 in 2000. Turnaround time for ethics committee review was a mean of 14 days. CONCLUSIONS: These data set important benchmarks for early-phase drug research in the UK where regulatory approval is not currently required. Furthermore, the information should be used as a guide if the competitive nature of such work in the UK is to be maintained as new national legislation is implemented following publication of the European Union (EU) Clinical Trials Directive.

Biomedical Research↗
PubMed1983

Training the "clinical scientist" through a combined industrial/academic fellowship.

A novel two-year fellowship program is described which provides specialized training both in clinical drug research and drug development methodology for pharmacists with previous clinical experience. Pharmaceutical industry, university and hospital research facilities are used as the training laboratories, and collectively offer theoretical as well as practical research skills development. Traditional didactic and laboratory training are provided within university and hospital environments with emphasis in the conduct of clinical trials. Extramural experience with pharmaceutical industry provides a corollary experience which includes exposure to ethical, legal and regulatory issues involving both investigational and marketed drugs. Following successful completion of the fellowship, the pharmacist is expected to have developed the fundamental skills necessary for a career in academia, pharmaceutical industry, or clinical practice.

Drug Industry↗
PubMed2002

The importance of being first: evidence from Canadian generic pharmaceuticals.

This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors.

Canada↗
PubMedDate not supplied

[The new pharmacy practice: can pharmaceutical intervention improve therapeutical efficiency].

BACKGROUND: The pharmaceutical activity has experienced over the last 50 years an important evolution in terms of concepts and contents affecting not only pharmacists but the whole health professionals. The subject of this study were the characteristics and implications of that change. METHODS: We review the main conditions leading to this change and characteristics of the new pharmaceutical activity focused mainly on the filtrate and alert about drug related problems and the professional intervention facing a proper resolution. RESULTS AND CONCLUSIONS: Some preliminary results from an investigation about the mentioned conditions are presented supporting the idea that this new proposed pharmaceutical intervention model can actually improve benefits on therapeutical effectiveness and save resources.

Ethics, Pharmacy↗
PubMedDate not supplied

Ethical dilemmas in pharmacy practice.

The purpose of this study was to document the responses of pharmacy students and pharmacists to various ethical dilemmas. The responses of the first professional year students, third professional year students and pharmacists were evaluated and compared. In most instances, responses indicated a high priority for patient/client welfare. Pharmacists and students reportedly act with regard to the dignity of life, individual freedom, and an inner sense of right.

Adolescent↗
PubMedDate not supplied

Methodological and political issues in clinical pharmacology research by the year 2000.

Parallel groups in a large, multicenter, phase III "pivotal" randomized clinical trial (RCT) with clinically relevant end-points are seen by the medical community as the "gold standard" of clinical research. However, there are limitations, some methodological and others political. The main one is the external validity of the method because a treatment, as studied in RCTs, does not necessarily reflect how it is used in clinical practice. Also, the method, as it stands, is not really predictive of the success in a particular patient of a certain intervention studied in a trial. To overcome these methodological drawbacks, different options have been implemented. The most important ones are: (1) the performance of pragmatic RCTs intended to address effectiveness rather than efficacy; (2) meta-analysis; and (3) the use of observational studies, with or without a comparison group. Recent experience has shown that type-A adverse drug reactions (ADRs) related to a specific class of drugs have been successfully characterized throughout cohort- or population-based case-control studies, whereas the evidence linking a specific drug entity to a type-B ADR, apparently severe enough to withdraw the drug from the market, has come mainly from case reports or case series. Other limitations of the RCT are more of a political nature. These large "pivotal" trials are mostly sponsored by the pharmaceutical industry, and to guarantee the scientific and ethical integrity of data produced, they are performed following standard operating procedures (SOPs) and good clinical practice (GCP) guidelines. Sometimes industry is not interested in sponsoring trials; thus, RCTs performed are in practice highly biased because of their potential economical profits. Furthermore, applying SOPs and GCPs is expensive and difficult to implement, and it is hard to find funding in public institutions. As a result, there is an urgent need to create a network of independent, skilled groups interested in sponsoring and performing institutional RCTs following "user friendly" GCP when the profits are low, but scientific interest high.

Forecasting↗
PubMed1998

Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine.

OBJECTIVE: To examine the frequency of obtaining Institutional Review Board (IRB) approval and informed consent in critical care research. DATA SOURCES AND DATA EXTRACTION: One-year retrospective review of original critical care research in humans published in seven journals, including American Journal of Respiratory and Critical Care Medicine, Chest, Critical Care Medicine, Intensive Care Medicine, The Journal of the American Medical Association, Lancet, and The New England Journal of Medicine. Studies were examined for general information (country/state where the research was performed, affiliation of the hospital to a medical school, and whether the work was supported by a grant and specifically by a pharmaceutical company), approval by IRB, method of consent, design of research, and interventions involved in the study. DATA SYNTHESIS: Two hundred seventy-nine studies were reviewed, 124 (44%) of which were conducted in the United States. Two hundred forty-three (87%) studies were performed in a university institution, 96 (34%) studies were supported by a grant, and 23 (24%) studies were supported by a pharmaceutical company. In 66 (24%) studies, there was no evidence of IRB review and informed consent approval. IRB approval was obtained but the method of consent was not specified in 36 (13%) studies. No significant differences were found in obtaining IRB approval and informed consent between research conducted in the United States (n=71, 57%) or outside the United States (n=92, 59%). Grant support was obtained in ten (9%) of the 116 studies not fully approved, compared with 70 (50%) of the 140 studies that obtained full approval (p < .05). All studies (23) supported by the pharmaceutical industry were fully approved. CONCLUSIONS: Many published studies in critical care lack IRB approval and/or informed consent. All research supported by the pharmaceutical industry was fully approved. The findings raise ethical concerns about critical care research.

Bibliometrics↗
PubMed2002

Lifestyle medicines and the elderly.

Lifestyle medicines are those used to meet patient aspirations rather than traditionally defined medical need. However, in many cases, the boundary between the two is ill defined and a matter of degree or cultural expectation. Such medicines are not yet widely used by the elderly, but this may change in an increasingly consumerist society. There are ethical, clinical and financial issues to be considered around these drugs, which are not independent. The ethical issues relate mainly to the rising consumerism in medicine, and whether these and other medicines are consumer goods available almost on demand. The clinical issues concern the balancing of risk and benefit for these medicines, and how we inform patients of these issues. The financial issues are who should pay and whether third party payers can and should ration these medicines and, if so, how. Lifestyle medicines may provoke a debate on the whole issue of rationing. These issues are not confined to the use of these medicines by the elderly and their resolution will depend on a broader societal debate, in which the elderly need to be active.

Aged↗
PubMed1987

Early clinical evaluation in man: the buck stops here.

The development of new drugs as potential therapeutic agents involves multi-discipline 'team' research. The clinician has to deal with scientific and ethical issues and keep in mind the axiom 'Primum no nocere--Above all, do no harm.' The clinical pharmacologist has to address the pharmacologic actions of a potential new drug and if any antidotes are available. Species in pharmacologic actions, assessment of animal laboratory data to determine the sensitive organs, and the role of drug metabolism in evaluating and correlating animal data all need to be addressed. The clinical pharmacologist has an important role in new drug development which is unique and includes the responsibility to ensure the welfare of the volunteer subjects or patients.

Animals↗
PubMed1992

Pharmacy agenda for change: the time is now.

In the midst of society's debate and focus on patient care and outcome, healthcare providers must articulate their strategic positioning to be part of the collective societal drive. Pharmacy as an integral component of healthcare provided, must also take the opportunity to create its own agenda for change. This agenda revolves around pharmacists agreeing on aspects of pharmaceutical care for which they are legally and ethically responsible. Pharmacists must also strive to gain social and cultural authority for those aspects for which the profession has accepted responsibility. Pharmacist action is needed to ensure appropriate drug therapy to the public.

Drug Utilization↗