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Clinical Equipoise
Clinical equipoise, also known as the principle of equipoise, provides the ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial. The term was first used by Benjamin Freedman in 1987, although references to its use go back to 1795 by Dr. Edward Jenner.Freedman, B. (1987) 'Equipoise and the ethics of clinical research'. ''The New England Journal of Medicine'', 317, (3):141–145. In short, clinical equipoise means that there is genuine uncertainty in the expert medical community over whether a treatment will be beneficial. This applies also for off-label treatments performed before or during their required clinical trials. An ethical dilemma arises in a clinical trial when the investigator(s) begin to believe that the treatment or intervention administered in one arm of the trial is significantly outperforming the other arms. A trial should begin with a null hypothesis, and there should exist no decisive Empirical evidence ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Null Hypothesis
In scientific research, the null hypothesis (often denoted ''H''0) is the claim that no difference or relationship exists between two sets of data or variables being analyzed. The null hypothesis is that any experimentally observed difference is due to chance alone, and an underlying causative relationship does not exist, hence the term "null". In addition to the null hypothesis, an alternative hypothesis is also developed, which claims that a relationship does exist between two variables. Basic definitions The ''null hypothesis'' and the ''alternative hypothesis'' are types of conjectures used in statistical tests, which are formal methods of reaching conclusions or making decisions on the basis of data. The hypotheses are conjectures about a statistical model of the population, which are based on a sample of the population. The tests are core elements of statistical inference, heavily used in the interpretation of scientific experimental data, to separate scientific claims fr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Empirical Evidence
Empirical evidence for a proposition is evidence, i.e. what supports or counters this proposition, that is constituted by or accessible to sense experience or experimental procedure. Empirical evidence is of central importance to the sciences and plays a role in various other fields, like epistemology and law. There is no general agreement on how the terms ''evidence'' and ''empirical'' are to be defined. Often different fields work with quite different conceptions. In epistemology, evidence is what justifies beliefs or what determines whether holding a certain belief is rational. This is only possible if the evidence is possessed by the person, which has prompted various epistemologists to conceive evidence as private mental states like experiences or other beliefs. In philosophy of science, on the other hand, evidence is understood as that which '' confirms'' or ''disconfirms'' scientific hypotheses and arbitrates between competing theories. For this role, it is important that ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Controlled Trials
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'experimental' a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Surgical
Surgery ''cheirourgikē'' (composed of χείρ, "hand", and ἔργον, "work"), via la, chirurgiae, meaning "hand work". is a medical specialty that uses operative manual and instrumental techniques on a person to investigate or treat a pathological condition such as a disease or injury, to help improve bodily function, appearance, or to repair unwanted ruptured areas. The act of performing surgery may be called a surgical procedure, operation, or simply "surgery". In this context, the verb "operate" means to perform surgery. The adjective surgical means pertaining to surgery; e.g. surgical instruments or surgical nurse. The person or subject on which the surgery is performed can be a person or an animal. A surgeon is a person who practices surgery and a surgeon's assistant is a person who practices surgical assistance. A surgical team is made up of the surgeon, the surgeon's assistant, an anaesthetist, a circulating nurse and a surgical technologist. Surgery usually spa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Therapeutic Misconception
Therapeutic misconception is a common ethical problem encountered in human subjects research. It was originally described in 1982 by Paul Appelbaum and colleagues. The idea was introduced to the bioethics community in 1987. The formulation given by Appelbaum ''et al.'' in 1987 was the following: “To maintain a therapeutic misconception is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself.” Context and definitions Therapeutic misconception did not receive great attention until the early 2000s, when references to the concept expanded significantly. Originally only used in the context of randomized controlled trials, the term is now commonly used among sociologists, neuroscientists, and clinical investigators. Therapeutic misconception Therapeutic misconception is detrimental to a subject’s understanding of a study, which is crucial for an autonomous decision. Certain factor ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bracketing (phenomenology)
Bracketing (german: Einklammerung; also called phenomenological reduction, transcendental reduction or phenomenological ''epoché'') is the preliminary step in the philosophical movement of phenomenology describing an act of suspending judgment about the natural world to instead focus on analysis of experience. Its earliest conception can be traced back to Immanuel Kant who argued that the only reality that one can know is the one each individual experiences in their mind (or Phenomena). Edmund Husserl, building on Kant’s ideas, first proposed bracketing in 1913, to help better understand another’s phenomena. Overview Immanuel Kant Though it was formally developed by Edmund Husserl (1859–1938), phenomenology can be understood as an outgrowth of the influential ideas of Immanuel Kant (1724-1804). Attempting to resolve some of the key intellectual debates of his era, Kant argued that ''Noumena'' (fundamentally unknowable things-in-themselves) must be distinguished from '' ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cartesian Doubt
Cartesian doubt is a form of methodological skepticism associated with the writings and methodology of René Descartes (March 31, 1596Feb 11, 1650). Scruton, R.''Modern Philosophy: An Introduction and Survey''(London: Penguin Books, 1994). Leiber, J., ed., ''A Philosophical Glossary'', Philosophy Department, University of Houston, 2001p. 88 Cartesian doubt is also known as Cartesian skepticism, methodic doubt, methodological skepticism, universal doubt, systematic doubt, or hyperbolic doubt. Cartesian doubt is a systematic process of being skeptical about (or doubting) the truth of one's beliefs, which has become a characteristic method in philosophy. Additionally, Descartes' method has been seen by many as the root of the modern scientific method. This method of doubt was largely popularized in Western philosophy by René Descartes, who sought to doubt the truth of all beliefs in order to determine which he could be certain were true. It is the basis for Descartes' statement, "' ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Suspension Of Judgment
Suspended judgment is a cognitive process and a rational state of mind in which one withholds judgments, particularly on the drawing of moral or ethical conclusions. The opposite of suspension of judgment is ''premature judgement'', usually shortened to ''prejudice''. While prejudgment involves drawing a conclusion or making a judgment before having the information relevant to such a judgment, suspension of judgment involves waiting for all the facts before making a decision. Law Suspension of judgment is used in civil law to indicate a court's decision to nullify a civil judgment. Motions to set aside judgments entered in civil cases in the United States district courts are governed by Rule 60 of the Federal Rules of Civil Procedure which opens with the statement, "On motion and just terms, the court may relieve a party or its legal representative from a final judgment, order, or proceeding...". The rule is quite straightforward and court room application is mostly as stated. In ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ethical Principles
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory. Three major areas of study within ethics recognized today are: # Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determined; # Normative ethics, concerning the practical means of determining a moral course of action; # Applied ethics, concerning what a person is obligated (or permitted) to do in a sp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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