Table 4.
Data availability of pharmaceutical companies displaying certification via PhRMA or EFPIA websites which solicit data requests via online data sharing platform [47, 83, 84]
| Pharmaceutical company | Clinical data made available | Publicized date of earliest available data |
|---|---|---|
| Request point:https://clinicalstudydatarequest.com [52] | ||
| Astellas [55, 85] | Phase 1, 2, 3 and 4 studies for indications which have been approved by the US and, or EU | January 1, 2010 |
| Bayer [56] | All trials required for regulatory approval | January 1, 2014 |
| Chugai [86] | All sponsored clinical trials | January 1, 2014 |
| Eisai [61] | Phase 2, 3 and 4 studies required for regulatory approval which have been approved by the US and, or EU. | January 1, 2014 |
| GlaxoSmithKline [64, 87, 88] |
All global interventional studies All interventional studies since 2013 Other studies where data are provided to researchers |
December 1, 2000 |
| Novartis [89] |
Phase 2 and 3 studies required for regulatory approval in the EU or US Requested studies must support the indication |
January 1, 2014 |
| Roche [75] | All phase 2 and 3 studies or phase 4 studies required for regulatory approval. Products terminated from development. | January 1, 1999 |
| Sanofi [67] | All trials, for approved indications, required for regulatory approval in the US and EU | January 1, 2014 |
| Shionogi {Shionogi & Co. Ltd., 2018 #3717} | Phase 1, 2, 3, and 4 studies used for regulatory approval in the US, EU, and Japan | February 1, 2019 |
| Sumitomo Dainippon Pharma Co, Ltd. [90] | Phase 2, 3, and 4 interventional clinical studies included in the submission package for approved medications in the US, EU, or Japan | January 1, 2014 |
| UCB [70] | Phase 2, 3, and 4 study data for approved medicines and indications | November 1, 2008 |
| Viiv Healthcare [65] | Phase 2, 3, and 4 study data for approved medications | November 1, 2017 |
| Research fundersa |
Phase 1, 2, 3, and 4 interventional clinical studies Phase 1, 2, 3, and 4 interventional clinical studies for terminated compounds |
January 1, 2010 |
| Request point: https://yoda.yale.edu/how-request-data [91] | ||
| Johnson & Johnson [72, 92, 93] | Phase 2, 3 and 4 studies for products approved in the US and EU | January 1, 1990b |
| Request point:https://vivli.orgc [80] | ||
| Abbvie [53] | Phase 2, 3 and 4 interventional clinical studies for medicinal products and indications which received authorization in US or EU | May 1, 2004 |
| Biogen [94] | Phase 1, 2, 3 and 4 interventional clinical trials for products and indications submitted to and approved in the US and EU. | January 1, 2004 |
| Boehringer Ingelheim [58] | All trials with published results | January 1, 1998 |
| Celgene [60, 95] | Studies supporting indications approved in the US and EU | January 1, 2014 |
| Daiichi-Sankyo [96] | Phase 2, 3 and 4 interventional clinical studies submitted for approved medications in US, EU or Japan | January 1, 2014 |
| GlaxoSmithKline [64, 88] |
Global interventional studies Interventional studies evaluating medicines, starting in or after 2013 Consumer healthcare studies completed on or after January 1, 2018 |
December 1, 2000 |
| Johnson & Johnson [72, 92, 93] | Phase 2, 3 and 4 studies for products approved in the US and EU | January 1, 1990b |
| Lilly [63] |
Phase 2, 3 and 4 studies submit for regulatory approval to FDA on or after 1999 Phase 2, 3, 4 global studies after January 2007 Phase 2, 3, 4 regional studies for drugs approved in US and EU since January 1, 2014 |
January 1, 1999 |
| Pfizer [66, 97] | Global interventional studies conducted for medicines, vaccines, and medical devices which were terminated or are approved in the US or EU | September 1, 2007 |
| Takeda [70] | Phase 1,2,3 and 4 trials which support products approved in the US, EU, and/or Japan and products terminated from development | January 1, 2005 |
| UCB [70] | Phase 2, 3, and 4 study data for medicines and indications approved in the US and EU | January 1, 2007 |
| Request point:https://astrazenecagroup-dt.pharmacm.com/DT/Home/Login | ||
| AstraZeneca [98–100] | Phase 1, 2, 3, or 4 studies for approved indications in the US, EU, or Japan | January 1, 2009* |
| Request point: https://biogen-dt-external.pharmacm.com/DT/Home | ||
| Biogen [57] | Phase 1, 2, 3, or 4 studies for discontinued compounds or those approved in the US and EU | January 1, 2014 |
| Request point:https://fasttrack.force.bms.com/ | ||
| Bristol-Myers Squibb [59, 101] | Phase 1, 2, 3, or 4 study data for medicines and indications approved in the US or EU | January 1, 2008 |
| Request point: https://www.celgeneclinicaldatasharing.com | ||
| Celgene [60, 95] | Study data for compounds and indications approved in the US and EU | January 1, 2014 |
| Request point:http://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/ | ||
| Chiesi [102] | Study data for medications approved by the FDA or EMA | January 1, 2015 |
| Request point:https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html | ||
| EMD Serono [63, 103] | Study data for products and indications approved in the US and EU | January 1, 2014 |
| Request point:https://clinicaltrials.menarini.com/en-US/Home/Register | ||
| Menarini [104, 105] | Study data for medications and indications approved in the US and EU | Unclear |
| Request point:http://engagezone.msd.com/ | ||
| Merck & Co. [73] | Study data submit for regulatory approval in the US and EU for approved indications | September 1, 2007 |
| Request point:https://www.purduepharma.com/healthcare-professionals/clinical-trials/#request-trial-data | ||
| Purdue Pharmaceuticals [74] | Phase 2, 3 or 4 study data for drug products and their approved uses in the US for approved indications | January 1, 2014 |
| Request point: https://errs.regeneron.com/external | ||
| Regeneron [106] | Approved medicines and indications with publicly disclosed results | Unclear |
| Request point:https://clinicaltrials.servier.com/data-request-portal/login/ | ||
| Servier [107] | Study data for approved medications or indications in European Economic Area or US | January 1, 2014 |
aFunders include the Bill and Melinda Gates Foundation, Cancer Research UK, Medical Research Council, and Wellcome Trust
bElectronic data is available as far back as 1990. Study data prior to 1990 are only available in paper format and are not readily accessible
cVivli.org also provides access to data sponsored, stored or generated by BioLINCC, Critical Path Institute, Cure Duchenne, Doris Duke Charitable Foundation, Duke University, Harvard University, ImmPort, Johns Hopkins University, Project Data Sphere, the Leona M. and Harry B. Helmsley Charitable Trust and the University of California San Francisco