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NIHR Randomised Trials Methods

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 you are here › HomeNIHR Trials OverviewNIHR Randomised Trials Methods

The NIHR recognises the importance of sharing and communicating up-to-date information about the design, conduct, analysis and reporting of trials. A key aspect of the trials work is providing researchers with key information and resources to support NIHR trials.

This section provides information and resources concerned with good practice in randomised trial design and conduct, key research publications and examples of innovative trial designs or methodologies.

The information and resources listed offer good examples; if you know of other resources or information you think it would be useful to include, please get in touch.

key resources

 Key resources

Clinical Trials Toolkit: An innovative website designed to help navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements.

CONSORT Statement: An evidence-based, minimum set of recommendations for reporting randomised controlled trials (RCTs).

EQUATOR Network: An international resource centre for good reporting of health research studies.

GMC Good Practice in Research and Consent to Research: Supplementary guidance published by the General Medical Council (GMC) which sets out the good practice principles that doctors are expected to understand and follow if they are involved in research.

IDEAL Collaboration: An initiative to improve the quality of research in surgery (including trials), directed by an international Steering Group which includes surgeons and researchers in surgical and other innovative complex intervention areas, and coordinated by the University of Oxford.

MRC Complex Interventions Guidance: Guidance on development, evaluation and implementation of complex interventions to improve health.

MRC Guidelines for Good Clinical Practice in Clinical Trials: Guidance on good clinical practice (GCP) in trials.

NIHR Carbon Reduction Guidelines: A framework which identifies areas where sensible research design can reduce waste without adversely impacting on the validity and reliability of research.

Points to consider when assessing the feasibility of research: A guide produced by the Medicines for Children Research Network and the Association of Medical Research Charities. Many of the points discussed in the document apply to all types of clinical research, not just paediatrics.

SPIRIT 2013 Statement: An international initiative defining content that should be considered in a clinical trial protocol for interventional trials. NIHR funded researchers may find this a useful resource when preparing their protocol for ethics and other approvals.

useful papers

 Useful papers

What is a pilot or feasibility study? A review of current practice and editorial policy. Arain M, Campbell MJ, Cooper CL, Lancaster GA. BMC Medical Research Methodology 2010, 10:67. doi:10.1186/1471-2288-10-67

Reporting of Patient Reported Outcomes in Randomised Trials: the CONSORT PRO Extension. Calvert M, Blazeby J, Altman D, Revicki D, Moher D, Brundage, M for the CONSORT PRO Group. JAMA 2013, 309 (8) 814-822. doi:10.1001/jama.2013.879

Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R et al. Health Technol Assess 2007; 11(48):iii, ix-iii,105

Issues in data monitoring and interim analysis of trials. Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH et al. Health Technol Assess 2005; 9(7):1-iv

Design and analysis of pilot studies: recommendations for good practice. Lancaster GA, Dodd S, Williamson PR. Journal of Evaluation in Clinical Practice, 10: 307–312. doi: 10.1111/j..2002.384.doc.x

The use of surrogate outcomes in model-based cost-effectiveness analyses: a survey of UK Health Technology Assessment reports. Taylor RS, Elston J. Health Technol Assess 2009;13(8)

A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. J Clin Epidemiol, 2009 May; 62 (5):464-75. doi:10. 1016/j.jclinepi.2008.12.011

examples of innovative trials

 Examples of innovative
 trial designs or methods in NIHR

A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study: A 2 x 2 factorial design. (HTA Programme)

CRASH-2: tranexamic acid and trauma patients: A large successful trial using simple data collection. (HTA Programme).
Also see:

Development and evaluation by a cluster randomised trial of a psychosocial intervention in children and teenagers experiencing diabetes - the DEPICTED study: A trial achieving impressive public involvement through a stakeholder action group. (HTA Programme)

Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study: An informative feasibility study. (HTA Programme)

Efficacy and mechanism of low dose intradermal allergen immunotherapy in treatment of seasonal allergic rhinitis ('hay fever'): A study investigating efficacy and mechanism of an intervention. (EME Programme)

Imaging perfusion deficits and thrombolysis safety and efficacy in acute ischaemic stroke. The Third International Stroke Trial (IST-3): An embedded mechanistic study which is attached to an existing study. (EME Programme funded by MRC)

Molecular selection of therapy in metastatic colorectal cancer: a molecularly stratified randomised controlled trial programme (FOCUS 4): An adaptive trial. (EME Programme funded by MRC)

Prostate Testing for Cancer and Treatment (ProtecT) Feasibility Study: An informative feasibility study. (HTA Programme)

Randomised Controlled Trial of All-Wales Licensed Premises Intervention to Reduce Alcohol-Related Violence: An interesting trial which uses licensed premises as the units of randomisation (PHR Programme)

events and meetings

 Trial meetings, conferences
 and events

HTA conference 2013, 9 -10 October 2013, London: This event celebrates the contribution made by the Health Technology Assessment (HTA) Programme to the NIHR mission to improve the health and wealth of the nation.

UK Clinical Trials Methodology Conference - Methodology Matters, 18-19 November 2013, Edinburgh: This event is the second of its kind and provides opportunities to discuss issues and innovation in trials methodology research.

important contacts

 Key contacts

INVOLVE: A National Advisory Group (funded by the NIHR), which aims to promote active public involvement in NHS, public health and social care research. INVOLVE have published a number of documents aimed at researchers seeking to involve the public in their research.

Health Research Authority: A  newly formed NHS organisation established on 01 December 2011 as a Special Health Authority. The purpose of the HRA is to protect and promote the interests of patients and the public in health research. The HRA will work closely with other bodies, including the MHRA and NIHR, to create a unified approval process and to promote proportionate standards for compliance and inspection within a consistent national system of research governance. 

NIHR Research Design Service: A network that supports researchers to develop and design high-quality research proposals for submission to the NIHR and other national, peer-reviewed funding competitions for applied health or social care research.

Medicines and Healthcare products Regulatory Agency: A UK Government agency responsible for the regulation of medicines and medical devices and equipment used in healthcare, and the investigation of harmful incidents.

MRC Network of Hubs for Trials Methodology Research: A network of hubs, established by the MRC, to create a UK-wide regionally distributed research resource to improve the design, conduct, analysis, interpretation, and reporting of clinical trials.

MRC/NIHR Methodology Research Programme: A research programme that covers methodology research to underpin the biomedical sciences, experimental medicine, clinical trials, population health sciences, health services research and health policy. This programme is a key part of the MRC–NIHR joint strategy for publicly funded health research.

UKCRC Registered Clinical Trials Unit Network: This website provides the authoritative resource for information about UKCRC Registered CTUs. It provides comprehensive information and direct access to the units across the UK who have achieved UKCRC registration status. In addition, it offers the functionality to identify specific units that have expertise in a particular disease or therapeutic area, centrally coordinating multicentre trials, and in trial design, data management, and analysis.

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The NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), based at the University of Southampton, manages evaluation research programmes and activities for the NIHR.


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