NIHR Randomised Trials Coordination
The NIHR has developed activity concerned with the coordination of its randomised trials portfolio. NIHR Randomised Trials Coordination work provides a level of awareness and focus for NIHR trials activity. A focus on information sharing and awareness, coordination and maximising synergies across the NIHR is a key component.
Coordination activities focus around two main areas:
- Portfolio awareness and reporting (including development, refinement and improvement of reporting and information across NIHR Programmes and funding streams.
- Methods in Research (including development and signposting of key NIHR documents, guidance and expectations in the design, conduct and reporting of trials.
For more information please download the NIHR Randomised Trials Coordination document. (pdf, 48.09 KB)
Methods in research
A key aspect of NIHR Trials Coordination is concerned with ‘Methods in Research’. This development is intended to provide the NIHR research community with key information and resources regarding NIHR randomised trials activity.
This section provides researchers with information and resources concerned with good practice in randomised trial design and conduct, key research publications and examples of innovative trial designs or methodologies.
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.
HRA Guidance on questions that need answering when designing clinical trials: The Health Research Authority has published useful guidance to clarify which questions researchers, sponsors, peer reviewers, and ethics committees should ask when planning or reviewing clinical studies.
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.
Trial Managers’ Network (TMN) Guide to Efficient Trial Management: A reference tool, providing pragmatic advice and guidance to all those involved in the management of trials.
The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby JM. Journal of Clinical Epidemiology 2014, 67(8): 912-920. DOI: 10.1016/j.jclinepi.2014.03.010
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
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
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)
The PRECIS-2 tool: designing trials that are fit for purpose Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M; BMJ 2015;350:h2147
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
Examples of innovative trial designs or methods
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)
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)
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 centre 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.
If you know of any other resources that you think it would be useful to include, please get in touch.
Portfolio awareness and reporting
The NIHR, as the main public funder of trials in the UK and a world leader in research, is considering reporting arrangements for trials activities. This activity seeks to improve the information available on the NIHR trials portfolio.
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