DEVELOPING IDEAS

Assessing the Current Evidence

Recommended therapy areas should have a sound scientific rationale and should be subject to scientifically rigorous assessment. Where this has not been done, further research is necessary to improve the evidence base, prior to recommendation of effectiveness.

The first step before embarking on a clinical study is a Systematic Review (SR) of existing literature.

  • This supports the aims of REWARD, (the REduce research Waste And Reward Diligence) group - http://researchwaste.net

  • Systematic Review should have used EPPI-Centre Methodology www.eppi.ioe.ac.uk

  • Appropriate databases should have been searched to establish whether there are ongoing trials in the area through The NICE Evidence Services http://www.evidence.nhs.uk/

NICE Evidence Services is a free unique index of selected, authoritative and evidence-based information on health, public health and social care information from over 1000 trustworthy and accredited sources. Sources include: British National Formulary, Clinical Knowledge Summaries, SIGN, the Cochrane Library and Royal Colleges, Social Care Online and GOV.UK.

Levels of Evidence and Grade (figure 1) will be represented using traffic light representations. Green = high quality; Amber = moderate quality; Red = low quality

If a Cochrane Systematic Review of randomized controlled trials has been done then studies will be visually represented using the Cochrane Risk of Bias Tool (Figure 2) and GRADE recommendation. https://hsl.lib.umn.edu/biomed/help/levels-evidence-and-grades-recommendations

How do I develop my idea for study
This information was taken from CRUK publication Every Patient A Research Patient? Evaluating the current state of research in the NHS. Link to downloadable article: https://www.cancerresearchuk.org/sites/default/files/cruk_every_patient_may2015_web.pdf
Idea Generation
Clinical Trials Support Unit RDS http://www.rds.nihr.ac.uk/ NHS Clinicians & nurses National Cancer Research Institute (NCRI) Clinical Study Group. http://csg.ncri.org.uk/groups/clinical-studies-groups/brain/
Where do I get funding from?
Research Councils National Institute for Health Research (NIHR) Cancer Research UK Other Charities Industry
What do I do to get my study approved?
NHS England commissioners (approve excess treatment costs) Health Research Authority (HRA) and National Research Ethics Service (NRES) provide ethical and research governance approval NHS Trusts provide NHS R&D approvals Human Tissue Authority/Human Fertislisation and Embryology Authority (HTA/HFEA) Medicines and Healthcare Products Regulatory Authority (MRHA) provide regulatory and scientific approvals
Where do I get data to do my research?
National Cancer Intelligence Network (NCIN) in Public Health England Health & Social Care Information Centre (HSCIC) Medicines and Healthcare Products Regulatory Authority (MHRA) responsible for Clinical Practice Research Datalink (CPRD).
Where do I get Practical support to run my study?
Clinical Trials Units provide regulatorysupport and data collection NHS Trusts provide clinical time to recruit and run trials National Institute for Health Research (NIHR) Clinical Research Network provides nurses to administer treatments, supports patient recruitment Biomedical Research Centres and Units Experimental Cancer Medicines Centres (ECMC) provide nurses and data analysis for early stage cancer trials
How does my idea get put into practice?
Collaborations for Leadership in Applied Health Research and Care National Institute for Health Research (NIHR) Human Tissue Authority (HTA) Programme. The National Institute for Health and Care Excellence (NICE) Academic Health Sciences Networks (AHSNs) Clinical Reference Groups in NHS England