Table of Contents
What are the ethical issues in placebo use?
First, placebos are supposedly ineffective (or less effective than “real” treatments), so the ethical requirement of beneficence (and “relative” nonmaleficence) renders their use unethical. Second, they allegedly require deception for their use, violating patient autonomy.
What is an equivalence trial?
In an equivalence trial, the statistical test aims at showing that two treatments are not too different in characteristics, where “not too different” is defined in a clinical manner. Finally, in a non-inferiority trial, the aim is to show that an experimental treatment is not (much) worse than a standard treatment.
Is it ethical to use placebo in clinical trial?
The World Medical Association has reaffirmed its view that in general it is ethically unacceptable to conduct placebo controlled trials if a proven therapy is available for the condition under investigation.
What is the difference between equivalence and noninferiority trials?
Non-inferiority trials aim to show that the new drug is no worse than standard treatment. Equivalence trials aim to show the new treatment is no better and no worse. An equivalence boundary should be set before the trial. This is the definition of what would be the minimum important difference between the treatments.
Why are placebos ethical in research?
In some research, this can best be achieved by comparing an intervention against a control to identify the effects of the intervention. Used appropriately, a placebo control can provide valuable data, particularly when there is no accepted therapy for the condition under study.
What is a Randomised controlled equivalence trial?
The main CONSORT Statement provides recommendations for reporting randomized controlled trials, which aim to determine whether one intervention is superior to another. Equivalence trials, on the other hand, aim to determine whether one intervention is therapeutically similar to another.
Why are clinical trials unethical?
Clinical trials may be unethical because participants in the clinical trials assume equipoise i.e. that the chance of finding a benefit or a harm are equal and written signed consents are required.
What is the null hypothesis in an equivalence trial?
If researcher is interested in comparing the efficacy of two drugs then in statistical terms, the null hypothesis is defined as the situation of no difference i.e. the new drug is no better and the researcher is interested to disprove based on his scientific thinking is known as alternate hypothesis.
Is prescribing placebo ethical?
The Council on Ethical and Judicial Affairs (CEJA) report prohibits the deceptive use of placebos. The use of placebos is ethically acceptable provided that physicians have previously secured their patient’s informed consent.
Are double blind trials ethical?
The point is that double-blinding is ethical only if it serves a scientific purpose. If its real purpose is to keep subjects in the trial when it is not in their best therapeutic interest to remain–a conflict of interest if ever there was one –then the blinds should be lifted.
Why is determination of sample size important?
The size of a sample influences two statistical properties: 1) the precision of our estimates and 2) the power of the study to draw conclusions.
Why is sample size calculation important?
Why sample size calculations? The main aim of a sample size calculation is to determine the number of participants needed to detect a clinically relevant treatment effect. Pre-study calculation of the required sample size is warranted in the majority of quantitative studies.
How do you calculate sample size for superiority trial?
In a superiority trial, the sample size calculation is conventionally based on achieving adequate power to demonstrate that the relevant confidence limit for the difference between the two treatments excludes zero, assuming that the experimental treatment is superior by a given amount (‘delta’).
What are the main ethical issues in clinical trials?
To preserve human dignity and the rights of subjects, clinical trials must follow a framework of seven ethical principles:
- Social and clinical value.
- Scientific validity.
- Fair subject selection.
- Favorable risk-benefit ratio.
- Independent review.
- Informed consent.
- Respect for subjects.
Is bioequivalence research still relevant?
Although bioequivalence studies are still widely conducted, noninferiority and equivalence designs have evolved and are being extensively used in certain areas of medical research such as cardiology, dentistry, oncology, and health care service delivery to directly demonstrate therapeutic equivalence.
What are noninferiority and equivalence studies?
“Noninferiority” and “equivalence” are often used interchangeably to refer to trials in which the primary objective is to show that a novel intervention is as effective as the standard intervention. The use of these designs is becoming increasingly relevant to mental health research.
What are ethical issues in scientific research?
Ethical scientific research must be conducted in a manner that makes it beneficial rather than harmful to us, other organisms, and our earth. One ethical issue that scientists have to address when they are ready to begin a new research project is whether or not it is in the best interest of humanity.
Why is it important to establish statistical hypothesis for equivalence trials?
It is important to mention that equivalence or non inferiority cannot be proved by accepting the null hypothesis of no difference. Hence, establishing the appropriate statistical hypothesis is extremely important to arrive at meaningful conclusion for the set objectives in research. Keywords: Equivalence trials, Statistical hypothesis