TY - JOUR T1 - Transparency of COVID-19 vaccine trials: decisions without data JF - BMJ Evidence-Based Medicine JO - BMJ EBM DO - 10.1136/bmjebm-2021-111735 SP - bmjebm-2021-111735 AU - Sarah Tanveer AU - Anisa Rowhani-Farid AU - Kyungwan Hong AU - Tom Jefferson AU - Peter Doshi Y1 - 2021/08/08 UR - http://ebm.bmj.com/content/early/2021/08/08/bmjebm-2021-111735.abstract N2 - Summary boxData transparency has become a well-established norm in biomedical research, and is especially important for broadly used public health interventions like COVID-19 vaccines.Tax payers helped fund COVID-19 vaccine trials and should have the right to access the results.There is inadequate availability of COVID-19 vaccine trial documents and data; individual participant data will not be available for months, perhaps years, for most vaccines.Widespread use of interventions without full data transparency raises concerns over the rational use of COVID-19 vaccines.Trial transparency must start early and be continuous. Trial protocols should be released once finalised, before trial results are reported, and should be accompanied with the release of trial documents and data before clinicians and the public make decisions regarding product use.Access to data for drugs and vaccines has historically been fairly limited to journal article publications and hard-to-access and difficult to read regulatory reports.1 But the past decade has witnessed strides in clinical trial data transparency. A wide range of institutions, from pharmaceutical companies, government agencies, trade organisations, journals and not-for-profit organisations, have all acknowledged the importance of data sharing, including the release of deidentified individual participant data. Many policies, regulations and platforms now exist to facilitate data access, including landmark transparency policies from the European Medicines Agency (EMA)2 3 and Health Canada.4 Both regulators now post on their websites, sections of the licensure dossier received by the industry (https://clinicaldata.ema.europa.eu/ and https://clinical-information.canada.ca/). There are also industry and academic platforms to facilitate third-party access to trial data and documents, including ClinicalStudyDataRequest.com, Yale University Open Data Access (YODA) Project and Vivli.5 In 2013, the US and European industry trade organisations endorsed a joint statement on clinical trial data sharing, making a series of commitments that ‘recognise the importance of sharing clinical trial data in the … ER -