PP25 Data Transparency “Moving from Bad Pharma 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 Pa ents? transparency is o Higher quality, well overwhelming: 1) Enhanced Data Sharing with Researchers designed clinical trials bringing be er Regulatory agencies, BMJ, Cochrane o Pa ent-level trial data, study-level data, full CSRs (clinical study reports) and protocols for medicines to pa ents more quickly Collabora on and the medicines approved in US & EU from 1 Jan 2014 will be shared with qualified scien fic o More informed prescribing Alltrials campaign and medical researchers upon request & subject to “terms necessary to protect pa ent o Research into disease mechanisms o Secrecy considered increasingly privacy & confiden al commercial informa on”. o Increased longer term monitoring of unacceptable in todays society 2) Enhanced Public Access to Clinical Study Informa on Link to safety and efficacy Researchers granted access to data will be expected to publish Principles Industry Concerns: their findings. o Protec ng pa ent confiden ality Considera ons for Programmers o Preserving regulatory integrity 3) Shared Results with Pa ents Who Par cipate in Clinical Trials o Receiving & approving requests (protec ng intellectual property) Companies will work with regulators on establishing a mechanism to provide “factual o Opera onal considera ons (QC steps, summaries” of clinical-trial results to pa ents who take part in trials. o Maintaining incen ves for standard macros and approaches, SAS investment in clinical research 4) Cer fying Procedures for Sharing Clinical Trial Informa on data access systems) Synopses of CSRs submi ed to FDA, EMA or EU na onal authori es will be made publicly o Resource requirements, skillsets needed Industry Benefits: available once a new medicine /indica on approved. o A broadening role for the Programmer o Opportuni es for pharma to rebuild o Share experiences at PhUSE (A Day in reputa on 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 accusa ons of publica on results from all Phase III studies and clinical-trial results “of significant medical o Cross-pharma collabora ons bias importance” should be filed for publica on. o It’s the right thing to do! Protec ng Pa ent Confiden ality o De-iden fica on / anonymisa on Researcher Experience Regulatory requirements to consider o Conduct meta- o Recent EMA policy announcement on publica on of clinical reports o Methodologies & process analyses & (currently only documents). Future: EMA plans to make individual o Data u lity & risk systema c pa ent data available assessment reviews o Other policies point to increased transparency (e.g. new Clinical Trial o Industry standardisa on o Request & Regula on 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 documenta on likely to become increasingly important as o Obliga ons on both data providers pharmaceu cal industry incorporates transparency ac vi es into standard process of clinical trial repor ng & receivers