None of the aforementioned steps should be so strict that once the RCT is over, replication of the intervention is impossible in a practical setting. The logistics of a randomized controlled trial can be demanding. The required sample size to test a hypothesis is governed by the effect size If there are significant differences in the primary outcome between the two groups, one can conclude that the difference is likely to be due to the intervention. If a particular baseline characteristic is of such fundamental importance as to have a big influence on the outcome, it can be taken into account at randomization. For example, Jozwiak et al. Upward revision of the required sample size may result from the interim analysis as was the case in the WOMAN trial Rigorous ethical principles must be applied to all RCTs involving experiments on animals, humans or human biological material As is true of medicine, participants must not be harmed by the experiment. Cluster randomization can be used when randomization of individual participants is not feasible/practical, in which case hospitals, clinics, geographic areas etc. The simplest way of achieving this is by parallel group design, in which each group of participants is exposed to only one of the study interventions. The number of patients with missing outcome data should be minimized as far as possible. With the effects of possible confounding factors limited in this way, any differences in outcomes observed between the two groups can be ascribed to the intervention.A second inherent feature of the RCT design is the prospective follow-up of the participants. Including several sites has the advantage of reaching the required sample size within a shorter time and may also improve generalizability of findings.The main premise of conducting an RCT is that the participants should be treated exactly the same way in both arms except for the intervention/control treatment. A randomized controlled trial is a prospective, comparative, quantitative study/experiment performed under controlled conditions with random allocation of interventions to comparison groups. A case-control study is a better option and provides higher evidence for testing the prognosis of the long-term effect of silicone breast implants. An RCT has several characteristic features: RCTs are controlled, randomized, and usually blinded, and the significance of the results is determined statistically according to a predetermined algorithm. Therefore, whether it is a superiority, noninferiority or equivalence trial should be reported.It is not uncommon that some participants do not receive the intervention allocated by the randomization process.

Randomized controlled trials are generally considered to be the optimal epidemiological approach to assessing the effects of a treatment, but randomized controlled trials are rarely used in clinical teratology. The main reason for this is that evidence based on observational data is prone to bias. However, RCTs are not suitable for investigating etiology or natural history of disease. The randomized controlled trial is the most rigorous and robust research method of determining whether a cause–effect relation exists between an intervention and an outcome. There are four sequential phases of clinical trial that have the objective of: studying human pharmacology of the agent (phase I); exploring therapeutic potential (phase II); confirming therapeutic effect (phase III); and evaluating it for therapeutic use (phase IV). should follow the routine process and no undue advantage or testing should be performed on patients in the trial. The trial investigators or participants or both may be kept unaware of (“blinded” to) the trial arm to which participants have been allocated.

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