World Medical Association. Declaration of Helsinki: ethical principle for medical research involving human subjects. 2013. https://www.wma.net/policies
Department of Health. Research Governance Framework for Health and Social Care. 2005. https://www.hra.nhs.uk
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001; 357:(9263)1191-1194
Department of Health. Attributing the costs of health and social care Research & Development (AcoRD). 2015. https://www.gov.uk
United Kingdom Legislation. The Medicines for Human Use (Clinical Trials) Regulations. 2004. https://www.legislation.gov.uk
Greene LE, Bearn DR. Setting up a randomized clinical trial in the UK: approvals and process. J Orthod. 2013; 40:104-111
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.
Article
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.
Register now to continue reading
Thank you for visiting Orthodontic Update and reading some of our resources. To read more, please register today. You’ll enjoy the following great benefits:
