Participants Privacy And Rights
To ensure the safety of subjects who volunteer for clinical trials as well as preserving the integrity and credibility of the data reported, numerous regulatory boards including IRBs and DSMBs under the auspices of the federal government are involved with all studies conducted in the United States.
The rigorous methodology of executing a clinical trial, most significantly through the controlled and random intervention of human volunteers by the investigator, makes this epidemiologic study design one of the most powerful approaches to demonstrating causal associations in the practice of evidence-based medicine.
Enrollment and treatment allocation techniques, selected endpoints, methods of comparison, and statistical analyses are carefully chosen in order to plausibly achieve the intended goals of the study.
Emphasizing safety first, the most common route of studying a new therapeutic is from the establishment of the maximum tolerated dose in humans (phase I), to pharmacodynamic and pharmacokinetic studies, and exploration of therapeutic benefit (phase II), followed by comparing its efficacy to an established therapeutic or control in a larger population of volunteers (phase III), and ultimately post-market evaluation of adverse reactions and effectiveness when administered to the general population (phase IV).