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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 325 records · Page 18Linked to original sources
PubMed1998

Good clinical research practice: what is it and is it possible in the intensive care unit?

With the growing quest for answers to vexing dilemmas in critically ill patients, more intensive care units are embarking on clinical research. This places increasing importance on Good Clinical Research Practice (GCRP), a set of guidelines drawn up by the Pharmaceutical Industry to assist investigators in conducting ethical, reliable scientific studies. GCRP is a combination of good basic management skills allied to ethical principles for scientific research. Based on the principles of the Declaration of Helsinki, it consists of three tenets: patient protection (ethics), credible data (science) and data control. This article describes GCRP specifically relating it to the intensive care situation, illustrating some of the concepts with practical examples. With a minimum of extra time and effort these basic principles can be integrated as routine into all research projects.

Clinical Trials as Topic↗
PubMed2005

Pharmaceutical drug marketing strategies and tactics: a comparative analysis of attitudes held by pharmaceutical representatives and physicians.

A variety of promotional strategies have been used to stimulate sales of pharmaceutical drugs. Traditionally, push techniques have been the predominant means used to encourage physicians to prescribe drugs and thus increase sales. Recently, the traditional push strategy has been supplemented by a pull strategy. Direct-to-consumer advertising is increasingly used to encourage consumers to request advertised drugs from their physicians. This research compares the attitudes of two of the most affected participants in the prescriptive sales processes; physicians and pharmaceutical sales representatives. The findings indicate differences between physicians and pharmaceutical sales representatives regarding the efficacy and ethical considerations of various promotional strategies.

Adult↗
PubMed2001

Health care professionals and industry: reducing conflicts of interest and established best practices.

The relationship between health care providers and pharmaceutical companies and other commercial interests is ethically complex. The common practice of gift giving takes many forms including free samples, sponsorship of medical education, loan of equipment, and gifts ranging from those of nominal value such as pens to more valuable gifts such as golf outings or dinners. Gift giving is a practice that serves both the recipient and the giver, but, in the medical setting, it raises the question of whether this is to the detriment of patient care. Although health care professionals may believe they are able to ignore influence from commercial interests, human judgment research indicates that decision-makers are generally unaware of biases affecting their decisions. This is an issue of organizational ethics as well. Institutions that allow commercial interests to give some form of gift are allowing the appearance of bias as well as placing the burden of avoiding bias on the individual rather than on the institution. Conflict-of-interest analysis indicates that best practice is to limit or eliminate the influence of commercial interests, ensuring that professionals are better able to exercise their independent objective judgment.

Attitude of Health Personnel↗
PubMed2004

Control groups appropriate for surgical interventions: ethical and practical issues.

Surgical trials differ in several critical aspects from pharmaceutic trials because they are invasive and the procedure itself may carry a significant risk. The surgical procedure cannot be fully specified in advance; although the general approach may be the same, the exact methods used during surgery may differ. Surgeons may have different levels of skill and experience with the techniques; experience is known to affect success rates. Sham surgeries are difficult to justify ethically, yet they have been successful in showing that accepted surgical procedures were not efficacious. Double masking participants in a surgical trial may be difficult; for example, we cannot mask the surgeon. There is also a need to minimize or avoid bias. Therefore, greater flexibility is needed in the design of surgical trials than in the design of pharmaceutic trials. Some of this flexibility is possible through the use of more sophisticated statistical designs. At times, it is necessary to separate the provider of the treatment (the surgeon) from the evaluator of the success of the treatment (a different physician, research nurse, or study coordinator).

Ethics, Medical↗
PubMed2003

Good publication practice for pharmaceutical companies.

Guidelines on Good Publication Practice (GPP) for pharmaceutical companies are presented. The aim of the guidelines is to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. The guidelines cover companies' responsibility to an endeavour to publish results of all studies, companies' relations with investigators, measures to prevent redundant or premature publication, methods to improve trial identification and the role of professional medical writers. Our aim in publishing the GPP guidelines, which are the first to be developed by and for those working on publications in the pharmaceutical industry, is to stimulate discussion between journals, investigators and trial sponsors and to provide guidance to those who seek it. We also hope that pharmaceutical companies and others involved in developing publications arising from sponsored clinical trials will endorse the guidelines.

Drug Industry↗
PubMed2006

Conflict of interest in the physician interface with the biomedical industry.

The physician interface with the pharmaceutical industry stands at the forefront of a debate about the effect this relationship has on the behavior of both researchers and clinicians. The authors explore the basis for this conflict of interest and show how it affects physician judgment and behavior. These effects lead to negative consequences for patients and threaten the professional status that society accords physicians. In view of the potential for ethical compromise, physicians should refrain from contact with pharmaceutical marketing representatives.

Conflict of Interest↗
PubMed1995

The compensation of patients injured in clinical trials.

The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the interests of the patient, and we suggest a means whereby the patients can be assured of fair treatment in the event of 'no fault' injury.

Clinical Trials as Topic↗