PP25 Data Transparency “Moving from to Good Science?” Authors: Katherine Tucker (Roche) and Gary Hearfield (Amgen)

Evolving landscape What does Data The case for Transparency mean for increased Doctors and Paents? transparency is o Higher quality, well overwhelming: 1) Enhanced Data Sharing with Researchers designed clinical trials bringing beer Regulatory agencies, BMJ, o Paent-level trial data, study-level data, full CSRs (clinical study reports) and protocols for medicines to paents more quickly Collaboraon and the medicines approved in US & EU from 1 Jan 2014 will be shared with qualified scienfic o More informed prescribing Alltrials campaign and medical researchers upon request & subject to “terms necessary to protect paent o Research into disease mechanisms o Secrecy considered increasingly privacy & confidenal commercial informaon”. o Increased longer term monitoring of unacceptable in todays society 2) Enhanced Public Access to Clinical Study Informaon Link to safety and efficacy Researchers granted access to data will be expected to publish Principles Industry Concerns: their findings. o Protecng paent confidenality Consideraons for Programmers o Preserving regulatory integrity 3) Shared Results with Paents Who Parcipate in Clinical Trials o Receiving & approving requests (protecng intellectual property) Companies will work with regulators on establishing a mechanism to provide “factual o Operaonal consideraons (QC steps, summaries” of clinical-trial results to paents who take part in trials. o Maintaining incenves for standard macros and approaches, SAS investment in 4) Cerfying Procedures for Sharing Informaon data access systems) Synopses of CSRs submied to FDA, EMA or EU naonal authories will be made publicly o Resource requirements, skillsets needed Industry Benefits: available once a new medicine /indicaon approved. o A broadening role for the Programmer o Opportunies for pharma to rebuild o Share experiences at PhUSE (A Day in reputaon in media and society 5) Reaffirming Commitments to Publish Clinical Trial Results the Life of a “Data Sharing Specialist”) Companies will publish clinical-trial results regardless of study outcomes. At a minimum, o Avoid accusaons of publicaon results from all Phase III studies and clinical-trial results “of significant medical o Cross-pharma collaboraons importance” should be filed for publicaon. o It’s the right thing to do! Protecng Paent Confidenality o De-idenficaon / anonymisaon Researcher Experience Regulatory requirements to consider o Conduct meta- o Recent EMA policy announcement on publicaon of clinical reports o Methodologies & process analyses & (currently only documents). Future: EMA plans to make individual o Data ulity & risk systemac paent data available assessment reviews o Other policies point to increased transparency (e.g. new Clinical Trial o Industry standardisaon o Request & Regulaon April 2014 ensures all new studies are publically (PhUSE, EFSPI-PSI, access data registered and results published in publically accessible register) TransCelerate) o Different request models: CSDR.com, YODA, Duke, individual pharma websites Looking to the future Programmers role in providing data and documentaon likely to become increasingly important as o Obligaons on both data providers pharmaceucal industry incorporates transparency acvies into standard process of clinical trial reporng & receivers