Equipoise And The Ethics Of Clinical Research Pdf

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Access options available:. The American Journal of Bioethics 2. Ensuing responses generate a dialogue with interlocutors guaranteed to pad one's curriculum vitae for years to come.

Principle of Equipoise

Clinicians may one day be able to answer these questions by relying on computer models, thereby avoiding reliance on clinical research and the ethical concerns it raises. Until that day, clinical researchers begin by testing potential new medical interventions in the laboratory, and often in animals. While these methods can provide valuable information and, in the case of animal research, raise important ethical issues of their own, potential new interventions eventually must be tested in humans. Potential new interventions which work miracles in test tubes and in mice, often leave humans untouched, or worse off. The human tests of a medical intervention typically pose some risks to subjects no matter how many laboratory and animal tests have preceded them. In this way, the process of collecting data to improve health and well-being exposes research subjects to risks for the benefit of future patients. These studies thus provide a clear example of the central ethical challenge posed by clinical research: When is it ethically permissible to expose research subjects to risks of harm for the benefit of others?

Metrics details. This article is part of a series of papers examining ethical issues in cluster randomized trials CRTs in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged?

Clinical equipoise ; Equipoise. For example, to be able to conduct a clinical trial that involves administering an investigational treatment that may confer therapeutic benefit to subjects for whom such benefit is desirable to some individuals, and to administer a control intervention treatment that is not capable of conferring therapeutic benefit to others, there cannot be any evidence that suggests that the investigational intervention shows greater efficacy than the control treatment or that it leads to greater side effects than the control treatment. When individuals agree to participate in a clinical study, they do so with the understanding that all of the treatments are assumed to be of equal value. By the end of the trial, there Skip to main content Skip to table of contents. This service is more advanced with JavaScript available.

The American Journal of Bioethics

The principle of equipoise states that, when there is uncertainty or conflicting expert opinion about the relative merits of diagnostic, prevention, or treatment options, allocating interventions to individuals in a manner that allows the generation of new knowledge eg, randomization is ethically permissible. London AJ. Coronavirus Resource Center. Our website uses cookies to enhance your experience. Twitter Facebook Email. This Issue. Views 6,

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: The ethics of clinical research requires equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment. View on PubMed.

Don't have an account? This chapter argues that clinical equipoise does not offer sound ethical guidance regarding the appropriateness of randomized clinical trials as tools to generate the knowledge needed for drug approval or coverage decisions. It discusses five considerations that militate against appeal to equipoise as the arbiter of the ethical legitimacy of randomized trials to evaluate new treatments, even for life-threatening or highly debilitating conditions: the imprecision in defining the concept of equipoise; the reliance on expert opinion; the limitations of determining efficacy on the basis of surrogate outcomes; the high costs of new treatments; and the tendency toward premature termination of randomized clinical trials. The chapter also examines equipoise-driven consequences that bias the evidence base relevant to risk-benefit assessment. Finally, it illustrates the problem with using equipoise to determine whether a randomized clinical trial is ethically appropriate by focusing on the recent controversy surrounding the development of a new drug for patients with metastatic melanoma. Oxford Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Request PDF | On Aug 1, , Franklin G Miller published Equipoise and the Ethics of Clinical Research Revisited | Find, read and cite all the.

Equipoise and the ethics of clinical research

Ethics encompasses concepts and principles of right conduct. Ethics or morality has been defined as not committing any deed that definitely and deliberately harms others, and a concern for human well-being is the only intelligible basis for ethics or morality. In the past seven decades, modern medical ethics has reshaped medical practice tremendously.

The ethics of clinical research requires equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment. The current understanding of this requirement, which entails that the investigator have no "treatment preference" throughout the course of the trial, presents nearly insuperable obstacles to the ethical commencement or completion of a controlled trial and may also contribute to the termination of trials because of the failure to enroll enough patients. I suggest an alternative concept of equipoise, which would be based on present or imminent controversy in the clinical community over the preferred treatment. According to this concept of "clinical equipoise," the requirement is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferred treatment.

 - В сумке. - и улыбнулся, едва сохраняя спокойствие.


Глаза Беккера расширились. - Ты его. Двухцветный равнодушно кивнул. - Где оно? - не отставал Беккер. - Понятия не имею.

Equipoise and the Dilemma of Randomized Clinical Trials

Этим я и занимался сегодня весь день - считывал тексты с его терминала, чтобы быть наготове, когда он сделает первый шаг, чтобы вмонтировать этот чертов черный ход. Вот почему я скачал на свой компьютер его электронную почту. Как доказательство, что он отслеживал все связанное с Цифровой крепостью. Я собирался передать всю эту информацию в прессу. Сердце у Сьюзан бешено забилось.

 У нас есть время, но только если мы поспешим, - сказал Джабба.  - Отключение вручную займет минут тридцать. Фонтейн по-прежнему смотрел на ВР, перебирая в уме остающиеся возможности. - Директор! - взорвался Джабба.  - Когда эти стены рухнут, вся планета получит высший уровень допуска к нашим секретам.

Беккер проехал уже половину пути, когда услышал сзади металлический скрежет, прижался к рулю и до отказа открыл дроссель. Раздался приглушенный звук выстрела. Мимо. Он резко свернул влево и запетлял по дороге в надежде сбить преследователя и выиграть время.

The Ethics of Clinical Research

Сьюзан представила себе газетный заголовок: КРИПТОГРАФ ГРЕГ ХЕЙЛ РАСКРЫВАЕТ СЕКРЕТНЫЙ ПЛАН ПРАВИТЕЛЬСТВА ВЗЯТЬ ПОД КОНТРОЛЬ ГЛОБАЛЬНУЮ ИНФОРМАЦИЮ. Что же, это очередной Попрыгунчик. Вторично разоблачив попытку АНБ пристроить к алгоритму черный ход, Грег Хейл превратится в мировую знаменитость. И одновременно пустит АНБ ко дну.

Парень побелел. Беккер попридержал его еще минутку, потом отпустил. Затем, не сводя с него глаз, нагнулся, поднял бутылки и поставил их на стол. - Ну, доволен.

 Мы почти приехали, мисс Флетчер. Держитесь. Скоростной карт фирмы Кенсингтон повернул за угол и остановился. Сзади, перпендикулярно туннелю, начинался коридор, едва освещаемый красными лампочками, вмонтированными в пол. - Пойдемте, - позвал Бринкерхофф, помогая Сьюзан вылезти.