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There must be equipoise in order to justify conducting a clinical trial. True or False?
The correct answer is True. Clinical trials are an important part of the process of drug development. These trials have to be done before a drug can be approved and placed on the market. However, there needs to be equipoise when doing such trials.
This is a type of uncertainty which is based on the idea that no particular treatment is superior to another. Equipoise is important because it avoids bias which can negatively affect the validity of research results.
Objectivity is crucial in scientific studies of all kinds, and one way to achieve this is by random assignment of subjects to treatment groups. Another option which is even better is to also do double-blind studies, which means that neither the scientists nor the test subjects know what treatment they are getting.
There are three phases of clinical trials which are conducted on new drugs and are done after cell culture and non-human experimentation has been completed. Phase I is concerned with seeing if the drug has an adverse impact on individuals.
Phase 2 experiments examine the effectiveness of the drug for treating the condition it is designed for. and Phase 3 trials use a large sample size and help in detecting any side effects of the medicine.
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Clinical equipoise exists when the overall benefit or harm offered by the treatment to a patient is uncertain. The Clinical equipoise requires ethical conduct when performing clinical trials that involve assigning patients to different treatment arms. If the outcome of a treatment is known, such a trial has not been encouraged as it could introduce bias. This phenomenon, which is known as “equipoise” in North America, is known as the “uncertainty principle” in Europe. In an ideal situation, the principle of clinical equipoise is recognized, avoiding preferential treatment of one intervention against another.
If not followed, it could lead to bias and dilemma in deciding which patient should belong to the arm and which arm of the trial is significantly outperforming the other arm. It is unethical to conduct clinical trials on a drug whose efficacy has been clearly established, as the result cannot be generalized to other populations. There is also ethical impact of uncertainty, which should be justifiable when making a randomized or double-blind selection in trial design. The efficacy of the test drug or the efficacy in a different population should not be known. Documented information suggests that equipoise should be the decision of the physician who determines whether a patient should participate in a clinical trial. Results generated by methodological bias must be supported with a mechanism to reduce the bias, as many trials are known culprits of this unacceptable conduct.
What is meant by equipoise in clinical trials?
Equipoise provides a sense of balance when doing clinical trials because it is based on the assumption that no particular treatment is better than any other treatment. It is a form of uncertainty regarding which is the best and superior method.
In order for research findings to be valid, they need to have been tested in an objective manner. This means that the scientist conducting the trials must not show any treatment preference.
Clinical equipoise requires that test subjects, in this case, patients, are assigned to a particular treatment in a random fashion.
The bias of scientists can be a problem and therefore steps need to be taken to address this potential subjectivity. This is why equipoise is so important, and one way to also avoid bias is to conduct double-blind studies where neither the patient nor the scientists know which patients are receiving a particular drug.
In this case, there is a control in which a placebo is given and a treatment in which the drug is given, but none of the experimenters know which patients receive which option.
Randomized double blind control studies are recommended if at all possible since it helps to eliminate any potential subjectivity which could bias the interpretation of the results.
How clinical trials are conducted
2222222 involve testing of medications using people as test subjects. Usually, this stage of experimentation does not
occur until several other studies have been successfully completed. For instance, studies completed on cells grown in cultures,
and studies using non-human animals need to be done first.
Drug approval is a complicated process that involves at least three stages of testing on people. The phase I component is when
the proposed medication is first tested on healthy people or people who have the illness the drug is designed to treat.
Anywhere from 20 to 200 individuals are recruited for the clinical test. It may seem strange to test a drug on healthy people but
the reality is that there may be unwanted effects and toxicity of the medication which can be detected in people who are healthy.
It is important to remember that before the phase I trials, the drug will have been tested on non-human animals and living cells first.
Phase 2 trials are designed to evaluate how effective the proposed medication is for treating the very illness it is designed for.
The sample size for phase 2 drug trials is usually at least 100 people.
It is crucial that a large sample size if used because otherwise, the results may not be valid statistically. These trials can also indicate
which dosage is the most effective for treating a particular condition.
The final stage of testing is the phase 3 clinical trials which test the effect of a drug on thousands of patients. The idea is to note how
effective the drug is and how many and what types of side effects occur.
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