The Principles of Clinical Research and Protocol Design program consists of a series of four courses, which together provide a foundation in the essential elements of well-constructed clinical research protocols and how these elements are applied in clinical trials and observational studies.
The goals of the training are to provide learners with knowledge and skills to increase their ability to:
Understand interventional and non-interventional clinical studies with an emphasis on meeting business needs.
Develop and/or review protocols for local clinical evaluation (LCE) studies and investigator-initiated studies (IIS).
Develop and submit quality protocols.
This course presents an overview of randomized clinical trials (RCTs), the most common trial type for demonstrating efficacy and safety in the development of new drugs, therapies, and other interventions. Key principles that define RCTs are reviewed, including types of control, randomization, and blinding. The various types of trial designs are explained with a focus on situations in which to apply each type. The course concludes with a discussion of the various groups that oversee clinical trials and how investigators can work with them.