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. Author manuscript; available in PMC: 2019 Feb 27.
Published in final edited form as: Circulation. 2017 Nov 13;137(9):938–947. doi: 10.1161/CIRCULATIONAHA.117.031883

Table 2.

Inclusion Criteria, Number of Trials with Available Individual Patient-Level Data, and Estimated Total Trial Portfolio by Industry Sponsor.

Sponsor Inclusion Criteria for Data Sharing # of Shared Cardiometabolic Trials # of Shared Other Trials Total Trials with Available Data Crude Estimate of Trial Portfolio per Sponsor* % of Estimated Trial Portfolio with Shared Data on CSDR
Astellas Phase 1–4 interventional studies for approved products completed after 1/2010
Phase 1–4 interventional studies for compounds terminated after 6/2015		 12 26 38 624 6
Bayer Approved products (by both FDA and EMA) after 1/2014
Approved products (by only 1 agency) after 1/2014 if no plan for ongoing review or submission		 0 8 8 763 1
Boehringer Ingelheim – 75 262 337 1303 26
Daiichi-Sankyo Phase 2–4 interventional studies for approved products after 1/2014 (by FDA and EMA) 16 0 16 165 10
Eisai Phase 2 and 3 studies for approved products after 1/2014 (by FDA and EMA) accepted for publication
Phase 4 published interventional studies for approved products after 1/2014 (by FDA and EMA)		 0 7 7 251 3
GSK Global interventional studies ongoing or started after 12/2000
All interventional studies started after 1/2013		 234 1793 2027 2633 77
Lilly Phase 2–4 interventional studies for FDA-approved products on/after 1999
Phase 2–4 global interventional studies for FDA- and EMA-approved products started after 1/2007
Phase 2–4 regional/local interventional studies for FDA- and EMA-approved products started after 1/2014		 13 253 266 953 28
Novartis Phase 2–3 studies for previously approved products (by FDA and EMA) being submitted for new indication as of 1/2014 with decision regarding original study publication
Phase 2–3 studies for approved products prior to 1/2014 (case-by-case review) with decision regarding original study publication		 3 65 68 1455 5
Roche Phase 2 and 3 studies started after 1/1999
Phase 4 studies for approved or terminated products started after 1/1999		 11 176 187 858 22
Sanofi Phase 2–4 interventional clinical studies for approved products after 1/2014 with accepted manuscript of original study 27 7 34 1379 2
Takeda Phase 1–4 intervention trials for approved products after 1/2005
Phase 1–4 interventional trials for products terminated on or after 1/2014		 146 165 311 430 72
UCB Pivotal studies for regulatory approval of certolizumab, lacosamide, rotigotine, levetiracetam 0 34 34 324 10
ViiV Phase 2–4 global interventional studies of HIV drugs 0 41 41 43 95
All Sponsors 537 2,837 3,374 11,181 30
*

ClinicalTrials.gov was queried for completed, interventional trials sponsored by the company without limits to study completion/initiation dates, global or regional enrollment, drug approval status, or publication status.

Abbreviations: CSDR = ClinicalStudyDataRequest.com; EMA = European Medicines Agency; FDA = Food and Drug Administration; GSK = GlaxoSmithKline; HIV = human immunodeficiency virus.