Ushering in a New Era of Open Science Through Data Sharing The Wall Must Come Down

JAMA The Journal of the American Medical Association (Impact Factor: 30.39). 03/2013; 309(13):1-2. DOI: 10.1001/jama.2013.1299
Source: PubMed
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    ABSTRACT: Background: Data sharing from clinical trials can be key to the development and approval of medicines for rare diseases. Many events during the first half of 2013 have contributed to the movement for increased transparency. These include the development of the European Medicines Agency's new data publication policy, the creation of the AllTrials petition and GlaxoSmithKline's choice to sign it, the launch of GlaxoSmithKline's system for access to patient-level clinical trial data and Roche's commitment to create a similar system, the release of results from the Yale University Open Data Access project's first medicine analysis for Medtronic, and the creation of the Reg4All website. Aims/Objectives: This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline. Methods: GlaxoSmithKline's database of available trials was tabulated and graphs of relevant trial characteristics were produced. Results/Conclusions: Due to current transparency initiatives, it is likely that much more data will be made available over the next few years through systems similar to GlaxoSmithKline's. Although some aspects of GlaxoSmithKline's model could limit its usefulness, the data currently listed is diverse and could be promising for researchers interested in rare disease treatment. © 2013 S. Karger AG, Basel.
    Public Health Genomics 01/2013; 16(6):322-35. DOI:10.1159/000355941 · 2.46 Impact Factor
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    ABSTRACT: Background Authors of systematic reviews have difficulty obtaining unpublished data for their reviews. This project aimed to provide an in-depth description of the experiences of authors in searching for and gaining access to unpublished data for their systematic reviews, and to give guidance on best practices for identifying, obtaining and using unpublished data. Methods This is a qualitative study analyzing in-depth interviews with authors of systematic reviews who have published Cochrane reviews or published systematic reviews outside of The Cochrane Library. We included participants who 1) were the first or senior author of a published systematic review of a drug intervention, 2) had expertise in conducting systematic reviews, searching for data, and assessing methodological biases, and 3) were able to participate in an interview in English. We used non-random sampling techniques to identify potential participants. Eighteen Cochrane authors were contacted and 16 agreed to be interviewed (89% response rate). Twenty-four non-Cochrane authors were contacted and 16 were interviewed (67% response rate). Results Respondents had different understandings of what was meant by unpublished data, including specific outcomes and methodological details. Contacting study authors was the most common method used to obtain unpublished data and the value of regulatory agencies as a data source was underappreciated. Using the data obtained was time consuming and labor intensive. Respondents described the collaboration with other colleagues and/or students required to organize, manage and use the data in their reviews, generally developing and using templates, spreadsheets and computer programs for data extraction and analysis. Respondents had a shared belief that data should be accessible but some had concerns about sharing their own data. Respondents believed that obtaining unpublished data for reviews has important public health implications. There was widespread support for government intervention to ensure open access to trial data. Conclusions Respondents uniformly agreed that the benefit of identifying unpublished data was worth the effort and was necessary to identify the true harms and benefits of drugs. Recent actions by government, such as increased availability of trial data from the European Medicines Agency, may make it easier to acquire critical drug trial data.
    05/2013; 2(1):31. DOI:10.1186/2046-4053-2-31
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    ABSTRACT: The authors review the potential benefits and unintended consequences of the broad sharing of participant-level data from clinical trials. Several options for governance structures that could be implemented to provide expanded access to clinical trial data are discussed. Data from clinical trials, including participant-level data, are being shared by sponsors and investigators more widely than ever before. Some sponsors have voluntarily offered data to researchers,(1),(2) some journals now require authors to agree to share the data underlying the studies they publish,(3) the Office of Science and Technology Policy has directed federal agencies to expand public access to data from federally funded projects,(4) and the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have proposed the expansion of access to data submitted in regulatory applications.(5),(6) Sharing participant-level data may bring exciting benefits for scientific ...
    New England Journal of Medicine 10/2013; 369(17):1651-8. DOI:10.1056/NEJMhle1309073 · 54.42 Impact Factor
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