Article: Volume 12 Number 4 Page 145 - October 2019

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  Orth Update 2019; 12: 145-150

Orthodontics:  How to Design and Set Up a Clinical Trial Part 2: Protocols and Approvals

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Abstract: Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This second article describes the steps involved in designing and setting up a clinical trial, from writing a protocol to gaining the necessary approvals. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients.

Clinical relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand and be able to interpret the data from clinical trials.

Author notes: Amarpreet Atwal, BDS Hons, MOrth RCSEd, ISFE Orthodontics, Consultant in Orthodontics, Royal Derby Hospital (email: and Philip E Benson, BDS, FDS(Orth), PhD, Professor and Honorary Consultant in Orthodontics, University of Sheffield, Claremont Crescent, Sheffield S10 2TA, UK.

Objective: To understand the importance of research questions(s) and have some knowledge about what should be included in a protocol for a clinical trial.