Randomized placebo-controlled clinical trials have been the ‘golden standard’ during the last decades in the development of new drug therapies. This scientifically valid approach has recently been questioned in the fifth revised version of the Declaration of Helsinki, which states that the use of placebo-controlled clinical trials is only acceptable when no proven treatment exists for the studied disease. The World Medical Association further claims that no national ethical, legal or regulatory requirements should be allowed to reduce or eliminate any of the statements in the declaration. In spite of this, the document is not generally accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations. In the evaluation process for a drug to be approved in many countries today, clinical investigators at the hospitals and researchers at the pharmaceutical companies are obliged to use study protocols that would be rejected if the new declaration were to be fully adopted. Adherence to the clinical trial guidelines of the International Headache Society could also mean violation of the new Helsinki declaration of ethics.
Some ethics committees have already adopted the new declaration, which has caused concern among clinical investigators, who find this document to be vastly out of the line with common practice. At the moment, the situation is unclear and debated with increasing polarity concerning the scientific and ethical issues regarding the use of placebo in clinical trials. (Benatar, Keet, Prozesky. 1994) Standard of care for human subjects: Medical ethicists have debated quality-of-care issues for human subjects ever since clinical trials have been conducted internationally. The number of foreign clinical investigators increased 16-fold over the decade 1991-2001. This astronomical rate of growth is expected to continue, fueled both by the unsurpassed ability of foreign trial sites to recruit patients and by the substantially cheaper costs of foreign trials.
The Research paper on Clinical Trials
India: A Future Clinical Hub 1 India: A Future Clinical Trial Hub Analysis of Indian and Global conditions, susceptible for emerging India as a Clinical Trial Hub Kaustubh Aparajit, Samveg Sethi, Nitesh Kumar and Sachin Chavare, Shailesh J Mehta School of Management, IIT Bombay 1. Concept Definition 1.1 Clinical Trails Clinical Trials are studies performed with human subjects in order to test the ...
Ethicists have been concerned about the ethical basis of such studies because of perverse financial incentives to investigators (who often earn more from trials sponsors than they do from their medical practice), because of financial or medical treatment inducements to totally destitute patients who have no alternative route to treatment, and because of on-going concerns about the standard of follow-up care that patients will receive. (Bok. 1974) Given the escalating costs of continuing therapy for chronic conditions, the pharmaceutical industry and the U. S. have lobbied for relaxation of health-care standard that mandates that human subjects receive the best proven diagnostic and therapeutic method and instead have proposed a much a lower standard more in line with the prevailing standard of care otherwise available in the subject countries.
Given the erosion of health care standards in developing countries, most of which spend only $15-30 per person per year on health care services, the relevant standard of care will often be or third-class rather than first. The issue becomes particularly salient not just when deciding whether to provide a first-class or third-class therapy for a previously diagnosed condition, but also for determining the standard of care to be given if a person becomes HIV positive during the clinical trial of vaccine or a microbicide. These studies need large populations. Although trial participants are routinely urged to engage in safer sexual practices, the expected efficacy of initial vaccines and microbic ides is far less than 100%, so there will be a predictable and unavoidable incidence of HIV infection among trial participants. (Freedman. 1990)
The Research paper on Research Critique, Part 1
Introduction Critical appraisal of a research study demonstrates an understanding of the research study being conducted. This paper will review a qualitative research study designed to explore the lived experience of lay presence during adult cardiopulmonary resuscitation (CPR) in primary and secondary environments of care from a healthcare provider’s (HCP) perspective. The in-depth critical ...
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