Objectives of Good Clinical Practice in Clinical Research

PART ONE. OBJECTIVES OF GOOD CLINICAL PRACTICE IN CLINICAL RESEARCH

Worldwide acceptance of clinical data requires harmonization in the conduct of clinical trials. Clinical trials help to better understand diseases and their treatments and ensure an adequate evaluation of the safety and efficacy of new medicinal products or new indications of a marketed product before marketing authorization is granted.

Clinical research in general and drug development in particular are complex, scientific, regulatory-driven and long-term activities. In a clinical trial, the therapeutic intervention of interest may be a medicinal product, but can also be a medical device, or the combination of both, or any other clinical investigations that may have an impact on the safety and well-being of human subjects.

Drug development includes pharmaceutical development; new medicinal product formulation, preclinical activities (in laboratories and on animals) and clinical development (on humans) and requires several steps before marketing authorization is granted.

In this Good Clinical Practice training module, we focus on clinical research where administration of a medicinal product is the therapeutic intervention. The investigation may concern a newly discovered compound, often called new medicinal entity, or a recognized medicinal product for which a new indication or a new formulation is being developed. In all circumstances the therapeutic intervention is the administration of a so-called Investigational Medicinal Product.

Good Clinical Practice principles are recommended for all interventional clinical trials, including those with medical devices or other therapeutic interventions. Due to variations in rules and laws, this training module only focuses on "interventional clinical research of Investigational Medicinal Product".

PART TWO. PRECLINICAL ACTIVITIES

This section deals with pre-clinical activities to provide the course participants with an insight into the work that is required before the first administration of a new medicinal product in humans can take place. A full review of pre-clinical research requisite falls outside the scope of a basic Good Clinical Practice training program. Course participants who are interested in this particular topic are advised to look at the Investigator Brochure and/or consult qualified pre-clinical experts. The minimum information that should be included in an Investigator Brochure is delineated in ICH-Good Clinical Practice guidelines section seven.