Designing and Conducting Randomized Controlled Trials: Basic Concepts for Educating Early Researchers in the Field of Clinical Nutrition

Abstract

Randomized controlled trials (RCTs) provide the best quality evidence to steer patient care in the field of clinical nutrition. However, designing and conducting an RCT, analyzing data, interpreting and reporting its findings is rather complex for young researchers working in the field of clinical nutrition. This review article attempts to educate early researchers by offering a simple step by step guide on planning the key aspects (randomization, allocation concealment, blinding, outcome measures) of a trial, and highlighting the practical considerations (ethical clearance, trial registry, patient recruitment, trial monitoring) to be kept in mind while conducting a trial contextualised to clinical nutrition settings.