Keywords : Study design


A Beginner’s Guide to Clinical Trials

Sarah Keyes; Philippa Hawley

Canadian Journal of Medicine, 2022, Volume 4, Issue 1, Pages 4-12
DOI: 10.33844/cjm.2022.60615

Evidence-based medicine rests upon the pillars of scientific evidence, clinical expertise, and patient values. Evidence comes from various avenues including clinical trials; a branch of experimental research studying interventions in human participants. Clinical trials evaluate the safety and efficacy of interventions, including medications, devices, and procedures that are administered according to a detailed plan. A control group such as no-treatment, placebo, or standard-of-care is used for comparison. A clinical trial determines whether one intervention is better, worse, or no different than another in the specific context and demographics of enrolled participants. Safety and efficacy are established by measuring clinically significant outcomes. Ultimately, the goals of clinical research are to advance medical knowledge and improve patient care through the development of preventative measures, diagnostic and screening tools, treatments, and supportive care. In the rapidly evolving landscape of medical literature, clinicians increasingly consult clinical trials to guide their practice. As such, medical students and trainees stand to benefit from developing a strong understanding of research design and logistics during their training. This article presents a general overview of key elements and practical considerations in clinical trials.