# Clinical Trial ## Definition A clinical trial is a: - *planned experiment* designed to assess the efficacy of a treatment in humans by comparing the outcomes: - in a group of participants treated with an intervention (treatment) with - a *comparable group* of participants receiving a control treatment (i.e. placebo) - where participants are enrolled, treated, and followed over the same time period ## Significance Clinical trials are important because they: 1. are the definitive way to determine if a treatment is truly effective 2. determine safety of this treatment/intervention 3. improves the strength of causal inference 4. are subject to less issues of interpretation than observational studies ## Examples - Evaluating the effectiveness of a new anti-allergy medication on congestion - Comparing the survival of cancer patients on a new treatment versus the current medical standard ## Relevant Documents - The [[ICH E9]] describes the statistical prinicples that should be used for clinical trials ## Stages of Clinical Trial There are several [[Stages of Clinical Trials|stages of clinical trials]], each with a specific purpose in developing a drug for human consumption. --- # References [[Introduction to Statistical Methods for Clinical Trials#1. Introduction to Clinical Trials]]