RCT Protocols

The RCT or "randomized controlled trial" protocol is designed to ensure that results obtained in a trial are not manipulated or skewed by researchers. By randomizing the participants in the trial, the resulting data is more accurate and reliable, which in turn gives regulatory agencies and the public a better understanding of the true benefits of whatever is being tested. This is one effective way to keep companies honest when vetting a new product.

Inclusion Criteria

• A series of inclusion criteria must be established initially. These standards must be met by the subjects who are included in the study. Basic criteria can include age, type of impairment, gender, race, weight, pregnancy, or any other factors related to the underlying purpose of the study. For example, testing the effectiveness of a weight loss drug cannot be done objectively if only morbidly obese subjects are used, unless the drug is specifically intended for such individuals.

Exclusion Criteria

• Exclusion criteria must be established. This can include things such as pregnancy, involvement in prior trials, allergies, or various other conditions. Exclusion criteria are meant to eliminate subjects who have a direct conflict with what is being studied. Pregnancy is often an exclusionary factor for drug trials not because it might affect the outcome of the but rather because of the ramifications of how the drug might affect the developing fetus.

Reasoning

• The reasoning for all inclusionary and exclusionary criteria must be presented. This makes the trial transparent. Not only can the trial then be replicated but it also allows other scientists to analyze why the choices were made. Proving these are the right criteria to judge the effectiveness of the trial ensures a better outcome. All subjects must fit the inclusion criteria and not have any of the exclusion criteria for the test to be valid.

Randomizing

• Every subject who passes the inclusion/exclusion test will then be added to the test pool. This is the group of individuals who are eligible for the study and who can be invited to participate. Most scientists prefer the actual participants to be chosen from the test group via computer to ensure a purely randomized selection. Once there are enough participants, the study will begin.

  RCT can be used for blind or double blind studies. Most studies are at least blind, especially in medical trials, meaning the patient does not know whether he is receiving the new treatment. In a double blind study, neither the doctor nor the patient is unaware of who is receiving the treatment being evaluated in the trial.