The first reported clinical trial was conducted by James Lind in to identify treatment for scurvy. Ethics[ edit ] Although the principle of clinical equipoise "genuine uncertainty within the expert medical community For one, it has been argued that equipoise itself is insufficient to justify RCTs.
Impractical or unethical use of dummy treatments in RCTs Randomized controlled trials are the gold standard of scientific testing for new medical interventions.
They have become the standard that must be met by pharmaceutical companies in the process of working out what level of efficacy and safety can be achieved by an experimental drug.
The three words for this method of clinical testing - randomized controlled trial RCT - represent important elements of the scientific design: Randomized - the decision about whether a patient in the trial receives the new treatment or the control treatment or placebo is made randomly Controlled - the trial uses a control group for comparison or reference.
In the control group, the patients do not receive the new treatment being tested, but receive a reference treatment or placebo instead Trial - the drug or treatment is on trial during an RCT; it will be approved for wider use only if the results of the testing program indicate that there is a worthwhile level of efficacy, which must be balanced against an acceptable level of adverse effects safety.
Randomization is important in a clinical trial in order to prevent the results from being skewed. If the decision about who receives the new treatment in a clinical trial is not decided by random, the patients and scientists can influence the results.
The selection of patients into one arm of a clinical trial or the other into the treatment arm or the control group is left to the play of chance.
When patients are randomly assigned to the treatment or control arm of a clinical trial, the results are free from a specific type of selection bias. For example, without randomization, scientists may consciously or subconsciously assign patients to the treatment arm if they look more likely to benefit from the treatment under investigation, thus making a Randomized controlled trials essay look more beneficial overall than it may in fact be.
Conversely, if scientists are looking to demonstrate that a certain treatment is ineffective or unsafe, they may assign patients with a higher risk of complications or a lower chance of success to receive that treatment.
The chances of allocation bias may be considered higher in trials run by researchers either directly or indirectly funded by a pharmaceutical company looking to prove efficacy and safety of a new drug. This is why researchers must disclose any potential conflict of interest when conducting a clinical trial, as pharmaceutical manufacturers have a clear and usually very large financial interest in achieving positive results.
Knowing which patients are getting the experimental drug can result in sound motivations as well as questionable ones.
Doctors could have a well-intentioned influence over the results.
If the active treatment seems to be producing bad side-effects, for example, doctors may protect certain types of patient from the drug. Treating subjects in the trial differently in this way reduces the integrity of like-for-like comparisons and gives false results.
In summary, randomization in a clinical trial helps to remove bias and to ensure that the two groups being compared are truly similar, and that - as far as possible - the only difference that could influence the outcome in their disease is whether or not they are receiving the new drug.
Double- and single-blind trials In addition to randomization, a high-quality clinical trial is typically double-blind, or single-blind where double-blinding is not possible.
This means that the patients do not know if they are receiving the active treatment or a placebo single-blindor that patients and the physicians treating and assessing those patients are unaware of who is in the active treatment group double-blind. This kind of "blinding" helps to prevent results being skewed by patients who feel better simply because they know they are receiving active treatment or, conversely, who do not report feeling better because they know they are receiving a placebo or sham treatment.
Similarly, a double-blind trial reduces the potential for a treatment effect in patients and reduces the risk of the physicians or researchers reporting greater effects in the treatment group or lesser effects in the control group. For example, research on acupuncture can be difficult to carry out in a double-blind fashion as practitioners are inherently aware that they are administering a sham or active treatment.
In such cases, a trial may be single-blind i. Fast facts on randomized controlled trials Here are some key points about RCTs. More detail and supporting information is in the body of this article. Randomized controlled trials are the gold standard of clinical testing applied to new medical interventions.
RCTs are usually required in pharmaceutical testing programs before regulators will allow new drugs to be sold. Randomization means pure chance is used to decide who gets the new treatment and who goes into the comparison group of the trial.
RCTs are "controlled" so that investigators can reasonably expect any health effects to be the result of the drug treatment, by observing effects in the reference group not given the new drug.
Placebos may be used for the control group - dummy treatments that look the same as the experimental treatment but contain nothing.
It is not always ethical or practical to give a placebo, such as when this would mean denying treatment to people who have a life-threatening or serious illness. A standard treatment that is already established against the disease can be used in the control group for comparison.
The purpose of a control group in a randomized controlled trial is to help reduce the likelihood that any benefits and risks identified during the process can be attributed to factors other than the drug itself.Randomized controlled trials are the gold standard of scientific testing for new medical interventions.
They have become the standard that must be met by pharmaceutical companies in the process of. Check out this Study Design: Randomized Controlled Trial essay paper from per page or use for FREE.
Because of these capabilities, randomized Controlled Trials, as a study design, is used as the gold standard for health and disease surveillance studies. Indeed, if properly executed, this design has the capacity to offer the strongest.
There are some key distinctions between Randomized Controlled Trials (RCT) in a psychotherapeutic context and a medical context. There are key differences between the design of an RCT to evaluate a new drug and an RCT to evaluate a new form of couples’ therapy.
Custom Study Design: Randomized Controlled Trial essay paper A study design is an organized system or approach to carrying out a study.
Different forms of studies are carried out appropriately by using different research designs.
The term randomized controlled clinical trials is a methodologically sound alternate expansion for "RCT" in RCTs that concern clinical research; however, RCTs are also employed in other research areas, including many of the social sciences History.
The first reported. Medical education researchers are inevitably more familiar with the multisite randomized controlled trial (RCT) “gold standard” from the clinical research paradigm.
In an RCT, trainees are randomly assigned to receive 1 of 2 or more educational interventions. Randomized controlled trials are.