CLINICAL TRIALS PRINCIPLES, APPLICATION AND CONTRIBUTION IN DRUG DEVELOPMENT

Estella Tembe Fokunang*, Bayaga Herve, John Dobgima Fonmboh, Lovet Benyella Fokunang, Nubia Kristen Kaba and Charles Ntungwen Fokunang

ABSTRACT

Clinical trials of recent has received a lot of funding on comparative effectiveness research that has raised the importance of clinical trials the development and practice of evidence-based medicine and health care reform. Clinical trial is a very planned experiment designed to assess the efficacy of a treatment in man, by comparing the outcomes in a group of patients treated with the test treatment with those observed in a comparable group of patients receiving a control treatment, where both patients in both groups are enrolled, treated and followed over the same time period. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by improving the value of health care provided. Clinical trials also have the potential to present unknown risks to their participants, and biased knowledge derived from flawed clinical trials may lead to an unpredicted harm to patients. Although conducting a well-designed clinical trial may appear simple, it is based on rigorous methodology and oversight, governed by key ethical principles. This review aims at providing an overview of clinical trials, its ethical foundations, trial design, trial oversight, and the process of obtaining approval of a therapeutic agent, from its pre-clinical phase to post-marketing surveillance. With a more understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meeting one of the essential goals of health care reform.

Keywords: clinical trials, drug development; clinical trials, phase 0 to phase IV trial; randomized controlled trial.