The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. 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 . 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. 
The limitations of randomized, clinical trials must also be taken into account. While there is little doubt that randomized, controlled trials have significant and well-known advantages, they also have drawbacks. These include the difficulty in generalizing the results of research done in such well-controlled populations. In addition, Booth et al. [ 13 ], in a comprehensive review of 321 randomized oncology trials, noted that these trials have become larger with time, and more likely to have corporate sponsorship, and that for-profit sponsorship was independently associated with endorsement of the experimental arm.