Transparency of COVID-19 vaccine trials: decisions without data

S Tanveer, A Rowhani-Farid, K Hong… - BMJ evidence-based …, 2022 - ebm.bmj.com
S Tanveer, A Rowhani-Farid, K Hong, T Jefferson, P Doshi
BMJ evidence-based medicine, 2022ebm.bmj.com
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 …
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 Clin ical Stud yDat aRequest. 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 interest of patients, healthcare and the economy” 6 In 2015, the US Institute of Medicine similarly endorsed benefits of sharing clinical trial data, emphasising that ‘verification and replication of investigators’ claims’ were essential to the scientific process, and noting the numerous benefits to stakeholders ‘including payers of healthcare as well as patients, their physicians and researchers.’7
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