Abstract
By many measures, industry sponsorship is a crucial and even irreplaceable funding source for clinical research. This study aims to analyze the engagement of industry sponsorship in clinical research, which has seen a notable decline, from 43.61% in 2000 to 24.68% in 2020. To anatomy the characteristics of industry sponsored clinical trials and to diagnose its recent decline, 435,561 original records from ClinicalTrials.gov are analyzed to revisit the ever-changing role of industry sponsorship in clinical research, as well as its profound and far-reaching impacts. While the percentage of industry sponsorship in clinical trials has been decreasing in general throughout the last two decades, it remains the majority of funding sources for clinical research in specific areas around the Pacific Rim, but excluding the U.S. and China. Against the traditional wisdom that connects industry sponsorship to the late phases of clinical trials, it is observed that industry sponsorship shares a higher percentage than public sponsorship in and only in phase 1 clinical trials. Most significantly, data-driven results reveal that industry sponsorship contributes less to epidemic diseases than to non-communicable diseases. Recognizing this universal dilemma in the whole sector, the complementary roles of external collaboration and open innovation should be addressed to help facilitate R&D (research & development) decisions and hence improve investment returns in late phase clinical research. Analysis results remind policy-makers as well as related industry stakeholders of the need to further motivate the engagement of industry sponsorship in epidemic clinical research, especially during the post pandemic period.
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Appendices
Appendix 1: Statistics of clinical trials reported at clinicaltrials.gov by sponsor type
Total | Industry | Public | Public: University | Public: Hospital | ||
---|---|---|---|---|---|---|
Location | World | 438,655 | 133,640 | 305,015 | 187,437 | 84,723 |
Africa | 15,594 | 3334 | 12,260 | 9927 | 1327 | |
Central America | 3774 | 2541 | 1233 | 377 | 183 | |
East Asia | 54,536 | 20,503 | 34,033 | 23,463 | 23,518 | |
––Japan | 7258 | 6151 | 1107 | 824 | 237 | |
Europe | 124,974 | 42,063 | 82,911 | 48,950 | 30,056 | |
Middle East | 22,057 | 6512 | 15,545 | 8905 | 2848 | |
North America | 179,163 | 68,064 | 111,099 | 67,565 | 14,134 | |
––Canada | 26,370 | 12,550 | 13,820 | 8190 | 2698 | |
––Mexico | 4,601 | 3,231 | 1,370 | 224 | 366 | |
––United States | 161,162 | 63,204 | 97,958 | 59,916 | 11,402 | |
North Asia | 7575 | 6104 | 1471 | 592 | 123 | |
Pacifica | 10,090 | 7869 | 2221 | 1037 | 504 | |
South America | 13,326 | 5989 | 7337 | 3509 | 1806 | |
South Asia | 7698 | 2967 | 4731 | 2305 | 773 | |
Southeast Asia | 9020 | 4075 | 4945 | 3151 | 1583 | |
Start Date | 2000 | 1417 | 618 | 799 | 585 | 214 |
2001 | 1961 | 976 | 985 | 744 | 241 | |
2002 | 3240 | 1736 | 1504 | 1089 | 415 | |
2003 | 4694 | 2409 | 2285 | 1685 | 600 | |
2004 | 6417 | 3250 | 3167 | 2296 | 871 | |
2005 | 8328 | 3995 | 4333 | 3071 | 1262 | |
2006 | 10,024 | 4976 | 5048 | 3657 | 1391 | |
2007 | 11,826 | 5652 | 6174 | 4439 | 1735 | |
2008 | 13,770 | 6258 | 7512 | 5316 | 2196 | |
2009 | 15,173 | 6484 | 8689 | 6103 | 2586 | |
2010 | 16,184 | 6482 | 9702 | 6734 | 2968 | |
2011 | 17,167 | 6621 | 10,546 | 7209 | 3337 | |
2012 | 17,998 | 6400 | 11,598 | 7887 | 3711 | |
2013 | 18,678 | 6305 | 12,373 | 8375 | 3998 | |
2014 | 21,091 | 6846 | 14,245 | 9656 | 4589 | |
2015 | 22,879 | 6950 | 15,929 | 10,799 | 5130 | |
2016 | 25,035 | 7086 | 17,949 | 12,058 | 5891 | |
2017 | 26,556 | 7066 | 19,490 | 13,251 | 6239 | |
2018 | 28,463 | 7387 | 21,076 | 14,439 | 6637 | |
2019 | 30,094 | 7500 | 22,594 | 15,520 | 7074 | |
2020 | 31,071 | 7669 | 23,402 | 15,587 | 7815 | |
2021 | 34,480 | 9171 | 25,309 | 17,390 | 7919 | |
2022 | 31,713 | 8231 | 23,482 | 16,176 | 7306 | |
Phase | Phase 4 | 22,739 | 2619 | 20,120 | 13,295 | 6868 |
Phase 3 | 24,455 | 5502 | 18,953 | 10,455 | 5332 | |
Phase 2 | 73,842 | 33,946 | 39,896 | 22,852 | 10,351 | |
Phase 1 | 57,507 | 33,341 | 24,166 | 14,092 | 5371 | |
Indication | NCD | 210,742 | 69,172 | 141,570 | 81,402 | 42,854 |
-CVD | 54,015 | 15,769 | 38,246 | 23,858 | 12,660 | |
-Cancer | 94,554 | 31,907 | 62,647 | 32,515 | 17,790 | |
-CRD | 43,202 | 14,556 | 28,646 | 16,766 | 9165 | |
-Diabetes | 18,971 | 6940 | 12,031 | 8263 | 3239 | |
Indication | Epidemics | 12,507 | 3364 | 9143 | 5031 | 2751 |
-COVID-19 | 8737 | 1921 | 6816 | 3805 | 1986 | |
-MERS | 54 | 20 | 34 | 20 | 6 | |
-H1N1 | 250 | 127 | 123 | 65 | 31 | |
-SARS | 3466 | 1296 | 2170 | 1141 | 728 |
Appendix 2: Shares of major sponsor types of clinical trials reported at ClinicalTrials.gov
Total (%) | Industry (%) | Public (%) | Public: University (%) | Public: Hospital (%) | ||
---|---|---|---|---|---|---|
Location | World | 100.00 | 30.47 | 69.53 | 42.73 | 19.31 |
Africa | 100.00 | 21.38 | 78.62 | 63.66 | 8.51 | |
Central America | 100.00 | 67.33 | 32.67 | 9.99 | 4.85 | |
East Asia | 100.00 | 37.60 | 62.40 | 43.02 | 43.12 | |
-Japan | 100.00 | 84.75 | 15.25 | 11.35 | 3.27 | |
Europe | 100.00 | 33.66 | 66.34 | 39.17 | 24.05 | |
Middle East | 100.00 | 29.52 | 70.48 | 40.37 | 12.91 | |
North America | 100.00 | 37.99 | 62.01 | 37.71 | 7.89 | |
-Canada | 100.00 | 47.59 | 52.41 | 31.06 | 10.23 | |
-Mexico | 100.00 | 70.22 | 29.78 | 4.87 | 7.95 | |
-United States | 100.00 | 39.22 | 60.78 | 37.18 | 7.07 | |
North Asia | 100.00 | 80.58 | 19.42 | 7.82 | 1.62 | |
Pacifica | 100.00 | 77.99 | 22.01 | 10.28 | 5.00 | |
South America | 100.00 | 44.94 | 55.06 | 26.33 | 13.55 | |
South Asia | 100.00 | 38.54 | 61.46 | 29.94 | 10.04 | |
Southeast Asia | 100.00 | 45.18 | 54.82 | 34.93 | 17.55 | |
Start Date | 2000 | 100.00 | 43.61 | 56.39 | 41.28 | 15.10 |
2001 | 100.00 | 49.77 | 50.23 | 37.94 | 12.29 | |
2002 | 100.00 | 53.58 | 46.42 | 33.61 | 12.81 | |
2003 | 100.00 | 51.32 | 48.68 | 35.90 | 12.78 | |
2004 | 100.00 | 50.65 | 49.35 | 35.78 | 13.57 | |
2005 | 100.00 | 47.97 | 52.03 | 36.88 | 15.15 | |
2006 | 100.00 | 49.64 | 50.36 | 36.48 | 13.88 | |
2007 | 100.00 | 47.79 | 52.21 | 37.54 | 14.67 | |
2008 | 100.00 | 45.45 | 54.55 | 38.61 | 15.95 | |
2009 | 100.00 | 42.73 | 57.27 | 40.22 | 17.04 | |
2010 | 100.00 | 40.05 | 59.95 | 41.61 | 18.34 | |
2011 | 100.00 | 38.57 | 61.43 | 41.99 | 19.44 | |
2012 | 100.00 | 35.56 | 64.44 | 43.82 | 20.62 | |
2013 | 100.00 | 33.76 | 66.24 | 44.84 | 21.40 | |
2014 | 100.00 | 32.46 | 67.54 | 45.78 | 21.76 | |
2015 | 100.00 | 30.38 | 69.62 | 47.20 | 22.42 | |
2016 | 100.00 | 28.30 | 71.70 | 48.16 | 23.53 | |
2017 | 100.00 | 26.61 | 73.39 | 49.90 | 23.49 | |
2018 | 100.00 | 25.95 | 74.05 | 50.73 | 23.32 | |
2019 | 100.00 | 24.92 | 75.08 | 51.57 | 23.51 | |
2020 | 100.00 | 24.68 | 75.32 | 50.17 | 25.15 | |
2021 | 100.00 | 26.60 | 73.40 | 50.44 | 22.97 | |
2022 | 100.00 | 25.95 | 74.05 | 51.01 | 23.04 | |
Phase | Phase 4 | 100.00 | 11.52 | 88.48 | 58.47 | 30.20 |
Phase 3 | 100.00 | 22.50 | 77.50 | 42.75 | 21.80 | |
Phase 2 | 100.00 | 45.97 | 54.03 | 30.95 | 14.02 | |
Phase 1 | 100.00 | 57.98 | 42.02 | 24.50 | 9.34 | |
Indication | NCD | 100.00 | 32.82 | 67.18 | 38.63 | 20.33 |
-CVD | 100.00 | 29.19 | 70.81 | 44.17 | 23.44 | |
-Cancers | 100.00 | 33.74 | 66.26 | 34.39 | 18.81 | |
-CRD | 100.00 | 33.69 | 66.31 | 38.81 | 21.21 | |
-Diabetes | 100.00 | 36.58 | 63.42 | 43.56 | 17.07 | |
Indication | Epidemics | 100.00 | 26.90 | 73.10 | 40.23 | 22.00 |
-COVID-19 | 100.00 | 21.99 | 78.01 | 43.55 | 22.73 | |
-MERS | 100.00 | 37.04 | 62.96 | 37.04 | 11.11 | |
-H1N1 | 100.00 | 50.80 | 49.20 | 26.00 | 12.40 | |
-SARS | 100.00 | 37.39 | 62.61 | 32.92 | 21.00 |
Appendix 3: Declining big pharma sponsors and industry sponsors in clinical trials
All sponsors | Industry sponsors | Big pharma sponsors | |
---|---|---|---|
2000 | 2288 | 618 | 149 |
2001 | 2897 | 976 | 302 |
2002 | 4113 | 1736 | 582 |
2003 | 5651 | 2409 | 881 |
2004 | 7455 | 3250 | 1230 |
2005 | 9333 | 3995 | 1351 |
2006 | 11,306 | 4976 | 1700 |
2007 | 12,938 | 5652 | 1782 |
2008 | 14,907 | 6257 | 2006 |
2009 | 16,263 | 6484 | 1964 |
2010 | 17,394 | 6481 | 1818 |
2011 | 18,287 | 6619 | 1694 |
2012 | 19,329 | 6400 | 1511 |
2013 | 20,200 | 6303 | 1352 |
2014 | 22,456 | 6845 | 1296 |
2015 | 24,096 | 6948 | 1393 |
2016 | 26,160 | 7085 | 1240 |
2017 | 27,477 | 7065 | 1271 |
2018 | 29,388 | 7384 | 1240 |
2019 | 30,844 | 7487 | 1164 |
2020 | 31,791 | 7655 | 1220 |
2021 | 35,020 | 9129 | 1298 |
2022 | 32,090 | 8271 | 1084 |
Appendix 4: Mixed effects logistic regression estimates of key factors’ effects on the number of industry sponsors
Type III tests of fixed effects | ||||
---|---|---|---|---|
Source | Numerator df | Denominator df | F | Sig |
Intercept | 1 | 1454 | 186.272 | < 0.001 |
Phase | 1 | 1453 | 76.971 | < 0.001 |
Year | 1 | 1453 | 188.874 | < 0.001 |
Phase * Year | 1 | 1453 | 77.649 | < 0.001 |
Estimates of fixed effects | |||||||
---|---|---|---|---|---|---|---|
Parameter | Estimate | SE | df | t | Sig | 95% confidence interval | |
Intercept | − 49,791.030 | 3648.189 | 1454 | − 13.648 | < 0.001 | − 56,947.305 | − 42,634.755 |
Phase | 11,684.882 | 1331.869 | 1453 | 8.773 | < 0.001 | 9072.291 | 14,297.474 |
Year | 24.927 | 1.814 | 1453 | 13.743 | < 0.001 | 21.369 | 28.484 |
Phase * Year | − 5.836 | 0.662 | 1453 | − 8.812 | < 0.001 | − 7.135 | − 4.537 |
Estimates of covariance parameters | ||||||
---|---|---|---|---|---|---|
Parameter | Estimate | SE | Wald Z | Sig | 95% confidence interval | |
Residual | 35,511.136 | 1317.488 | 26.954 | < 0.001 | 33,020.557 | 38,189.568 |
Intercept [subject = Region_A] | 83,514.254 | 30,636.041 | 2.726 | 0.006 | 40,692.013 | 171,400.483 |
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Huang, J. Diagnosing the declining industry sponsorship in clinical research. Scientometrics 129, 663–679 (2024). https://doi.org/10.1007/s11192-023-04887-z
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DOI: https://doi.org/10.1007/s11192-023-04887-z