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![Page 1: Finding out what’s already known and what’s already happening before planning additional research Iain Chalmers on behalf of Mike Clarke, Sally Hopewell.](https://reader038.fdocuments.net/reader038/viewer/2022102910/56649e995503460f94b9c60a/html5/thumbnails/1.jpg)
Finding out what’s already known and what’s already happening
before planning additional research
Iain Chalmerson behalf of
Mike Clarke, Sally Hopewelland Mona Nasser
Evidence-Based Research NetworkBergen, 3 December 2014
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Mike ClarkeBelfast
Sally HopewellOxford/Paris
Mona NasserPlymouth
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Embarking on research without reviewing systematically what is
already known - particularly when the research involves people or animals - is
unethical, unscientific, and wasteful.
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JAMA 1992;268:240-248.
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The human costs of failing to cumulate evidence from research scientifically
“Advice on some life-saving therapies has been delayed for more than a decade, while other treatments have been recommended long after controlled research has shown them to be harmful.”
Antman et al. JAMA 1992;268:240-8.
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Data from Clarke and Hopewell, 2013, cited in Chalmers et al., 2014
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20 animal studies: “The results of this review did not show convincing evidence to substantiate the decision to perform trials with nimodipine in large numbers of patients.
Stroke 2001;32:2433-8.
STUDIES IN ANIMALS
Horn J, Limburg M. Calcium antagonists for acute ischemic stroke. The Cochrane Database of Systematic Reviews, 2000
“46 trials were identified of which 28 were included (7521 patients). No effect of calcium antagonists on poor outcome at the end of follow-up (OR 1.07, 95% CI 0.97/1.18), or on death at end of follow-up (OR 1.10, 95% CI 0.98/1.24) was found.”
STUDIES IN HUMANS
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[4][2]
[24][19]
Findings
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Some illustrative examples of waste from redundant research
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Sena et al. 2010
Redundant animal research
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Redundant clinical research…
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…leaving key questions unaddressed
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Cumulative odds ratios for front versus non-front sleeping position of sudden infant deaths versus controls. Gilbert et al. 2005.
Redundant epidemiological research
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“Systematic review of preventable risk factors for SIDS from 1970 would have led to earlier recognition of the risks of sleeping on the front and might have prevented over 10 000 infant deaths in the UK and at least 50 000 in Europe the USA and Australasia.”
Consequences of failure to analyse epidemiological research cumulatively
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What should research funders, research regulators, researchers
and journals do to reduce this sometimes lethal waste?
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Research funders
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NIHREngland
Yes – Applications to fund primary research have to be supported with systematic reviews of existing evidence. For commissioned calls, this will have been done by the funder.
NHMRCAustralia
No
CIHRCanada
Partially - Systematic reviews of prior clinical trials are encouraged but not required. There is a knowledge synthesis scheme but this does not seem to be related to funding for primary research.
NIHUSA
No – A ‘check of literature’ is encouraged but there is no clear guidance covering all projects or clinical trials.
MRCUK
No, in general – Only the Global Health Clinical Trial Unit requires systematic reviews, but none of the other major grant opportunities.
Do funders require applicants seeking support for primary research to refer to systematic reviews of existing evidence?
(Mona Nasser, personal communication)
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The Wellcome Trust
2013
2003
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MS Society supports systematic reviews
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http://www.nets.nihr.ac.uk/about/adding-value-in-research
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Research regulators
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Research ethics committees/IRBs
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Inappropriate continued use of placebo controls in clinical trials assessing the effects on death of antibiotic prophylaxis for colorectal surgery
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Health Research Authority
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Researchers
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? First use of the termEvidence-Based Research
Karen Robinson (2009). Use of prior research in the justification and interpretation of clinical trials. The Johns Hopkins University, ProQuest, UMI Dissertations Publishing, 2009. 3392375, p 123.
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Conceptualising an Evidence-Based Research Network
Tidsskrift for Den norske Legeforening, 29.11.2013, pp 2-3.
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Lund H (2014). From evidenced-based practice to evidence-based research - Reaching research-worthy problems by applying an evidenced-based approach. Eur J Physioth 16:65-6.
Announcement of An Evidence-Based Research Network
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Journals
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Low priority questions addressed
Important outcomes not assessed
Over 50% studies designed without reference to systematic reviews of existing evidence
Questions relevant
to users of research?
Over 50% of studies fail to take adequate steps to reduce biases
Studies with inadequate statistical power
Inadequate replication of initial observations
Appropriate research
design, conduct and analysis?
Over 50% of studies never published in full
Biased under-reporting of studies with disappointing results
Biased reporting of data within studies
Accessible, fullresearch reports?
Over 30% of trial interventions not sufficiently described
Over 50% of planned study outcomes not reported
Most new research not interpreted in the context of systematic assessment of other relevant evidence
Unbiased and usable reports?
Research waste
Increasing value and reducing waste in biomedical research. Lancet series, 8 Jan 2014
Hyper-regulation of research
Inefficient delivery of research
Poor re-use of data
Failure to promote evaluative research as an integral element of good clinical practice
Efficient researchregulation
and delivery?
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www.researchwaste.net
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Iain Chalmers, health services researcher
Michael B Bracken, epidemiologist
Benjamin Djulbegovic, oncologist, methodologist
Silvio Garattini, clinical pharmacologist
Jonathan Grant, science policy analyst
Metin Gulmezoglu, clinical trialist
David Howells, preclinical animal researcher
John PA Ioannidis, methodologist, bibliometrician
Sandy Oliver, social scientist
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Issue 1
Issue 2
Issue 3
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Recommendation 3
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Recommendation 4
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Chalmers I. Lancet 2000;356:774
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BMJ 2010;340:456-7
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Alessandro Liberati
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Patients have suffered and died unnecessarily and resources for research have been wasted because the research community has failed to review existing evidence systematically when planning new research.
Why should patients and the public trust us if we and our professional institutions fail to make systematic, efficient use of the results of the research that the public has funded?
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2006 2011
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Promote research on the effects of treatments…
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…but only if it meets scientific and ethical principles
Promote research on the effects of treatments…
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53
“This is an important, scary and encouraging book.”
“I think all doctors and medical students will benefit from this little book, which can be read in a few hours. It opens the eyes and gives medicine the critical foundation it needs.”
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Editor: Kjetil Olsen
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“Bad Science introduces the basic scientific principles to help everyone become a more effective bullshit
detector.”
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Embarking on research without reviewing systematically what is
already known - particularly when the research involves people or animals - is
unethical, unscientific, and wasteful.