Diagnosing the declining industry sponsorship in clinical research

Huang, Jianan

doi:10.1007/s11192-023-04887-z

Diagnosing the declining industry sponsorship in clinical research

Published: 07 December 2023

Volume 129, pages 663–679, (2024)
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Jianan Huang ORCID: orcid.org/0000-0001-6263-1658¹

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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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Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

Article Open access 30 December 2015

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Article Open access 05 June 2015

Rising pharmaceutical innovation in the Global South: a landscape study

Article Open access 27 November 2023

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National Institute of Education, Nanyang Technological University, Nanyang, 637616, Singapore
Jianan Huang

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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

Note 1. Source: United States National Library of Medicine, ClinicalTrials.gov, clinicaltrials.gov/ct2/home [Accessed on December 8, 2022 and April 18, 2023]
Note 2: Public sponsors refer to ‘NIH’, ‘Other U.S. Federal agency’, and ‘All Others (Individuals, Universities, Organizations)’ under the ‘Funder Type’ filter. University sponsors or hospital sponsors refer to clinical trials with the keyword ‘university’ or ‘hospital’ under the ‘Sponsor / Collaborator’ filter.
Note 3: NCD Non-Communicable Diseases, CVD Cardio-Vascular Diseases, CRD Chronic Respiratory Diseases

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

Note 1. Source: United States National Library of Medicine, ClinicalTrials.gov, clinicaltrials.gov/ct2/home [Accessed on December 8, 2022 and April 18, 2023]
Note 2: NCD Non-Communicable Diseases, CVD Cardio-Vascular Diseases, CRD Chronic Respiratory Diseases

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

Note 1. Source: United States National Library of Medicine, ClinicalTrials.gov, clinicaltrials.gov/ct2/home [Accessed on April 18, 2023]
Note 2: Among the top 20 pharmaceutical corporations by market capitalization worldwide, 10 pharms with longer histories and fewer name changes are selected and covered in the scope of statistics, i.e., Janssen, Lilly, Merck, Roche, Pfizer, AstraZeneca, Novartis, Sanofi, Bayer, and MSD

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

Note 1: Model here is mixed effects logistic regression with the number of industry sponsor as the dependent variable, clinical phase and starting year as fixed-effect covariates, and geographical region as a random-effect factor.

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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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Received: 16 August 2023
Accepted: 21 November 2023
Published: 07 December 2023
Issue Date: January 2024
DOI: https://doi.org/10.1007/s11192-023-04887-z

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Diagnosing the declining industry sponsorship in clinical research

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Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Rising pharmaceutical innovation in the Global South: a landscape study

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Publisher's Note

Electronic supplementary material

Supplementary file1 (XLSX 58 KB)

Appendices

Appendix 1: Statistics of clinical trials reported at clinicaltrials.gov by sponsor type

Appendix 2: Shares of major sponsor types of clinical trials reported at ClinicalTrials.gov

Appendix 3: Declining big pharma sponsors and industry sponsors in clinical trials

Appendix 4: Mixed effects logistic regression estimates of key factors’ effects on the number of industry sponsors

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Diagnosing the declining industry sponsorship in clinical research

Abstract

Access this article

Similar content being viewed by others

Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Rising pharmaceutical innovation in the Global South: a landscape study

References

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Authors and Affiliations

Corresponding author

Additional information

Publisher's Note

Electronic supplementary material

Supplementary file1 (XLSX 58 KB)

Appendices

Appendix 1: Statistics of clinical trials reported at clinicaltrials.gov by sponsor type

Appendix 2: Shares of major sponsor types of clinical trials reported at ClinicalTrials.gov

Appendix 3: Declining big pharma sponsors and industry sponsors in clinical trials

Appendix 4: Mixed effects logistic regression estimates of key factors’ effects on the number of industry sponsors

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