SeriesIncreasing value and reducing waste: addressing inaccessible research
Introduction
In 2010, Alessandro Liberati explained the difficulties he encountered when he had to make decisions about his treatment for multiple myeloma: “When I had to decide whether to have a second bone-marrow transplant, I found there were four trials that might have answered my questions, but I was forced to make my decision without knowing the results because, although the trials had been completed some time before, they had not been properly published….I believe that research results must be seen as a public good that belongs to the community—especially patients.”1 The benefits of health research can only be realised when the study methods and results are fully disseminated in a timely and unbiased manner.2 Availability of full information about study methods enables critical appraisal, interpretation of study results, and appropriate replication. Proper reporting of results can improve clinical practice and policy, prevent unnecessary duplication, and help to inform present and future research. Availability of participant-level data enables ancillary research and independent reanalysis of study results.
Despite advances in dissemination of study information, half of health-related studies remain unreported,3 and few study protocols and participant-level datasets are accessible. Inaccessibility of research is detrimental to care of patients and wastes much of the US$240 billion annual worldwide expenditure on health research.4 In this report, we document the extent and effect of non-dissemination and selective reporting of health research, and examine the options to reduce the waste and harms arising from inaccessible study information.
Section snippets
Access to primary reports
A published primary report is traditionally the main way by which research is communicated to the scientific community. Because unreported studies do not contribute to knowledge, they do not provide returns on the investment of research resources or the contributions of participants. For example, only half the health-related studies funded by the European Union between 1998 and 2006—an expenditure of €6 billion—led to identifiable reports.5 In the case of oseltamivir, unreported phase 3
Access to all study methods and results
Although the reporting of all studies has a major role in reductions in bias and improvements in transparency, journal publications alone are insufficient. Reporting of study methods and results is frequently incomplete and selective in journal articles, challenging their traditional role as the sole source of research information.32, 33 Produced by industry sponsors, a clinical study report is the most complete final report of study conduct and results, and contains the study protocol as an
Access to participant-level data
Beyond the compelling rationale for dissemination of primary reports, protocols, and full study reports, sharing of participant-level data has many benefits. First, errors, selective reporting, and fraud can be identified and deterred when others can verify statistical properties and calculations using participant-level data. A substantial proportion of reported studies have statistical errors,55, 56 and willingness to share data has been positively correlated with methodological quality.57
Recommendation 1
We propose three main recommendations to improve accessibility to full information from preclinical and clinical studies. First, institutions and funders should adopt performance metrics that recognise full dissemination of research. Incentives are needed to encourage investigators to complete and submit primary reports. Rather than focusing on total numbers of published reports, reviews of academic performance should explicitly take into account the proportion of a researcher's initiated
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