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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.
Trial registration[ edit ] Inthe International Committee of Medical Journal Editors ICMJE announced that all trials starting enrolment after July 1, must be registered prior to consideration for publication in one of the 12 member journals of the committee. From most to least common in the healthcare literature, the major categories of RCT study designs are: Crossover — over time, each participant receives or does not receive an intervention in a random sequence.
Factorial — each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions e. Pragmatic clinical trial RCTs can be classified as "explanatory" or "pragmatic.
First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be "restricted", or may be "adaptive.
Non-random "systematic" methods of group assignment, such as alternating subjects between one group and the other, can cause "limitless contamination possibilities" and can cause a breach of allocation concealment.
An ideal randomization procedure would achieve the following goals: Generally, equal group sizes maximize statistical power, however, unequal groups sizes maybe more powerful for some analyses e. This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.
The risk of selection bias is highest when previous treatment assignments are known as in unblinded studies or can be guessed perhaps if a drug has distinctive side effects. Minimize allocation bias or confounding. This may occur when covariates that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates i.
If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be biased if not adjusted for the covariates which may be unmeasured and therefore impossible to adjust for.
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages. Simple[ edit ] This is a commonly used and intuitive procedure, similar to "repeated fair coin-tossing.
However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over subjects. Permuted-block randomization or blocked randomization: This type of randomization can be combined with "stratified randomization", for example by center in a multicenter trialto "ensure good balance of participant characteristics in each group.
In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented. Covariate-adaptive randomization, of which one type is minimization: The probability of being assigned to a group varies in order to minimize "covariate imbalance.
The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.
Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes SNOSE ; sequentially numbered containers; pharmacy controlled randomization; and central randomization. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test.
The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test.
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But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small. Traditionally, blinded RCTs have been classified as "single-blind", "double-blind", or "triple-blind"; however, in and two studies showed that these terms have different meanings for different people.
For dichotomous binary outcome data, logistic regression e. For continuous outcome data, analysis of covariance e. For time-to-event outcome data that may be censoredsurvival analysis e. Regardless of the statistical methods used, important considerations in the analysis of RCT data include: Whether an RCT should be stopped early due to interim results.
For example, RCTs may be stopped early if an intervention produces "larger than expected benefit or harm", or if "investigators find evidence of no important difference between experimental and control interventions.
A "pure" intention-to-treat analysis is "possible only when complete outcome data are available" for all randomized subjects;  when some outcome data are missing, options include analyzing only cases with known outcomes and using imputed data.
These are "often discouraged" because multiple comparisons may produce false positive findings that cannot be confirmed by other studies.
Non-Pharmacologic Treatment Interventions   Relative importance and observational studies[ edit ] Two studies published in The New England Journal of Medicine in found that observational studies and RCTs overall produced similar results. If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs.One of the common features of an epic is the "fabulous loci" for the hero to visit.
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