EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers

Abstract

BackgroundAccess to patient level datasets from clinical trial sponsors continues to be an important topic for the Pharmaceutical Industry as well as academic institutions and researchers. How to make access to patient level data actually happen raises many questions from the perspective of the researcher.MethodsPatient level data access models of all major pharmaceutical companies were surveyed and recommendations made to guide academic researchers in the most efficient way through the process of requesting and accessing patient level data.ResultsThe key considerations for researchers covered here are finding information; writing a research proposal to request data access; the review process; how data are shared; and the expectations of the data holder. A lot of clinical trial information is available on public registries and so these are great sources of information. Depending on the research proposal the required information may be available in Clinical Study Reports and therefore patient level data may not need to be requested. Many data sharing systems have an electronic form or template but in cases where these are not available the proposal needs to be created as a stand-alone document outlining the purpose, statistical analysis plan, identifying the studies for which data are required, the research team members involved, any conflicts of interest and the funding for the research.There are three main review processes - namely having an internal review board, external review board selected by the data holder or an external review board selected by a third party. Data can be shared through Open access i.e. on a public website, direct sharing between the data holder and the researcher, controlled access or the data holder identifies a contract organization to access the data and perform the analyses on behalf of the researcher. The data that are shared will have accompanying documentation to assist the researcher in understanding the original clinical trial and data collection methods. The data holder will require a legally binding data sharing agreement to be set up with the researcher. Additionally the data holder may be available to provide some support to the researcher if questions arise.ConclusionWhilst the benefits and value of patient level data sharing have yet to be fully realised, we hope that the information outlined in this article will encourage researchers to consider accessing and re-using clinical trial data to support their research questions.

Data sharing: a new editorial initiative of the International Committee of Medical Journal Editors. Implications for the Editors’ Network

“…Nevertheless, when these are not available a "de novo" proposal should be generated outlining the purpose, the statistical analysis plan, the research team, and potential conflicts of interest. The review process may come from an internal or external review panel selected by the data holder or by a third party [25][26][27]. Finally, data can be shared through a public website or by direct communication between the data holder and the researcher.…”

Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…Furthermore, the data holder may require a legally binding data sharing agreement and should be available to provide the required support should questions arise. (27) Major care should be taken to prevent the perils that may undermine the value of data sharing. (14) Data from trials should be responsibly used.…”

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…Тем не менее, когда все они недо-ступны, следует сформировать заявку заново, с опи-санием цели, плана статистического анализа, иссле-довательской команды и возможных конфликтов интересов. Процесс обзора может исходить от внеш-ней или внутренней группы рецензирования, выбран-ной держателем данных или третьей стороной [25][26][27]. Наконец, данными можно обмениваться с по-мощью общедоступного веб-сайта или прямой связи между держателем данных и исследователем.…”

“…До начала любого анализа критически важ-ным остаётся пересмотр всей сопутствующей доку-ментации для помощи исследователю в понимании первоначального клинического исследования и ис-пользуемой методики. Более того, держатель дан-ных может потребовать юридическое соглашения об обмене данными и должен быть готов обеспечить необходимую поддержку в случае возникновения вопросов [27].…”