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How to design and set up a clinical trial part 2: protocols and approvals

From Volume 12, Issue 4, October 2019 | Pages 145-150


Amarpreet Atwal

BDS (Hons), MJDF, MOrth RCS

Post CCST Orthodontics, University of Sheffield and Royal Derby Hospital

Articles by Amarpreet Atwal

Email Amarpreet Atwal


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.

CPD/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.


This article will describe the steps involved in designing and setting up a clinical trial, from writing a protocol to gaining the necessary approvals.

The number (single or multi-centre), location (country), types of settings and care providers involved (eg primary, secondary, tertiary or community) must be determined. These will influence the generalizability and relevance of the trial to other settings and therefore the ability to guide clinical practice and policy.1

The main research question will aid researchers to determine the type of participants required (Figure 1). Clear inclusion and exclusion criteria are required to recruit suitable participants and simplify implementation of the trial. The eligibility criteria will allow others to interpret in which patients the results of the trial will apply. Baseline participant characteristics should be collected during the clinical trial for the same purpose.1

All clinical trials involve selecting a group of individuals (ie the sample), from a population, usually with a particular condition (target population). The sample group is investigated and the results are used to infer that a similar outcome would occur in all individuals with that condition, because it is not practical to include all individuals with that condition in a study.

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