Components of a randomized clinical trial

The purpose of this paper is to discuss a number of components associated with the design, development and conduct of a randomized clinical trial (RCT). In a RCT, a patient is entered into a protocol in which therapy is randomly assigned. Thus, neither the patient nor the care provider have active roles in deciding treatment. The elements of informed consent were developed to ensure that the patient's interests are protected. The informed consent document serves as the cornerstone of a clinical study by introducing patients to the research protocol, informing them of their role as participants in the study, and educating them of their rights. Questions regarding ethics arise during all phases of a study. A study designed with insufficient sample size will provide inconclusive data, thus making participation in the study of limited to no value. Conversely, having patients enrolled in a RCT after data has proved superiority of an arm of the study postpones beneficial therapy for patients and society. Other ethical conflicts arise when subjects are recruited for clinical trials. Special care must be taken to avoid coercion in protected populations such as students, employees, the mentally challenged, and the indigent. Careful planning with adequate attention to consent form development can minimize problems and optimize patient care and research integrity. The role of the RCT in the future is unclear. The logistics of conducting a multicentered trial has escalated the costs of new agents in terms of both time and money. In many cases, the decision to conduct a RCT is made on the potential profitability of the product/agent under test. Whatever the reasons credited for conducting an RCT, the research must be adequately designed to protect both the subjects involved in the study, as well as humankind from erroneous data.