Evidence map›Paper›PMID 24411646›Full record

ArticleLancet (London, England)2014

Increasing value and reducing waste in biomedical research regulation and management.

Rustam Al-Shahi Salman, Elaine Beller, Jonathan Kagan, Elina Hemminki, Robert S Phillips, Julian Savulescu, Malcolm Macleod, Janet Wisely, Iain Chalmers

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Lancet (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 215 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
215citing papers in PubMed, 18 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

215 citing papers in PubMed, 18 syntheses or guidelines pooled it.

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155 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Rustam Al-Shahi SalmanDivision of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK. Electronic address: rustam.al-shahi@ed.ac.uk.
Elaine BellerCentre for Research in Evidence-Based Practice, Bond University, Robina, QLD, Australia.
Jonathan KaganDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Elina HemminkiNational Institute for Health and Welfare, Helsinki, Finland.
Robert S PhillipsCentre for Reviews and Dissemination, University of York, York, UK.
Julian SavulescuOxford Centre for Neuroethics, University of Oxford, Oxford, UK.
Malcolm MacleodDivision of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
Janet WiselyHealth Research Authority, London, UK.
Iain ChalmersJames Lind Initiative, Oxford, UK.

Funding

Intramural NIH HHS Z99 AI999999Medical Research Council G1002605
6 · The paper itself

Abstract

After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, regulators and policy makers should work with researchers, patients, and health professionals to streamline and harmonise the laws, regulations, guidelines, and processes that govern whether and how research can be done, and ensure that they are proportionate to the plausible risks associated with the research. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.

Indexed as

BioethicsBiomedical ResearchResearch Design

Identifiers

PMID24411646
PMCPMC3952153

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.