TY - JOUR
T1 - Increasing value and reducing waste
T2 - Addressing inaccessible research
AU - Chan, An Wen
AU - Song, Fujian
AU - Vickers, Andrew
AU - Jefferson, Tom
AU - Dickersin, Kay
AU - Gøtzsche, Peter C.
AU - Krumholz, Harlan M.
AU - Ghersi, Davina
AU - Van Der Worp, H. Bart
N1 - Funding Information:
Funders should demand that researchers make participant-level data from studies funded by previous grants available before they are eligible to receive new funds. Funders should also include sufficient funds in grant budgets to pay personnel for preparation of datasets and associated documentation for data sharing. This investment, which in some instances could be substantial in absolute terms, is usually small relative to the time and costs needed to gather new data. 82,121 To avoid datasets becoming redundant, funders should also ask grant applicants to explain why new proposed datasets are needed. For example, the UK Economic and Social Research Council will not fund any dataset creation unless applicants confirm that no appropriate dataset is already available for reuse.
Funding Information:
TJ receives royalties from books published by Blackwells and Il Pensiero Scientifico Editore; is occasionally paid for interviews by market research companies for anonymous interviews about phase 1 or 2 products; is corecipient of a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors; was a paid consultant for Roche (1997–99), for GlaxoSmithKline (2001–02), and for Sanofi-Synthelabo for pleconaril (2003); acted as an expert witness in a litigation case related to oseltamivir (Roche; 2011–12); and was on a legal retainer for paid expert advice about litigation for influenza vaccines in health-care workers. HMK is the recipient of a research grant from Medtronic through Yale University to develop methods of clinical trial data sharing, and is chair of a cardiac scientific advisory board for UnitedHealth. HBvdW has received speaker's fees from Sanofi-Aventis, GlaxoSmithKline, and Springer Media; and has served as a paid consultant to Bristol-Myers Squibb. The other authors declare that they have no conflicts of interest.
Funding Information:
To maximise the return on investment of public funds, funding agencies should promote rigorous reporting practices by adopting policies for public posting of the protocol and full study report for all funded studies. For example, the Health Technology Assessment Programme in England requires a detailed full study report to be submitted, peer reviewed, and published in its own journal (which has no space restrictions), with the ability to also publish abbreviated reports in other journals. The programme withholds 10% of funds until the full study report has been submitted, meaning that one is available for 98% of studies that it has funded. 114 This policy has now been extended to all research funded by the National Institute for Health Research.
PY - 2014
Y1 - 2014
N2 - The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally aff ected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets.
AB - The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally aff ected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets.
UR - http://www.scopus.com/inward/record.url?scp=84892614609&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84892614609&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(13)62296-5
DO - 10.1016/S0140-6736(13)62296-5
M3 - Review article
C2 - 24411650
AN - SCOPUS:84892614609
SN - 0140-6736
VL - 383
SP - 257
EP - 266
JO - The Lancet
JF - The Lancet
IS - 9913
ER -