Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials

Figures & data

Table 1. Rate of discontinuation in every category of ATMPs

	Discontinued trials	Ongoing and completed trials	Total	Rate of discontinuation (%)
Somatic cell therapies	102 (71.33%)	271 (57.17%)	373 (60.45%)	27.35
Gene therapies	14 (9.79%)	72 (15.19%)	86 (13.94%)	16.28
Tissue-engineered products	25 (17.48%)	128 (27.00%)	153 (24.80%)	16.34
Combined products	2 (1.4%)	3 (0.64%)	5 (0.81%)	40
Total	143 (23.18%)	474 (76.82%)	617 (100%)	23.18

This table shows the number of discontinued, ongoing, and completed trials and the rate of discontinuation by ATMPs category, that is, somatic cell therapies, gene therapies, tissue-engineered products, and combined products.

Table 2. Phase of development and therapeutic areas targeted by the discontinued trials

Therapeutic area	Phase 1 and 1/2	Phase 2 and 2/3	Phase 3	Total	Discontinuation rate per disease area (%)
Cancer	56 (64.40%)	27 (31.00%)	4 (4.60%)	87 (60.84%)	43.06
Cardiology	16 (55.17%)	11 (37.93%)	2 (6.90%)	29 (20.28%)	19.20
Immunodeficiency and inflammation	4 (57.14%)	1 (14.29%)	2 (28.57%)	7 (4.89%)	10.45
Musculoskeletal diseases	2 (50.00%)	1 (25.00%)	1 (25.00%)	4 (2.80%)	6.78
Neurology	4 (80.00%)	1 (20.00%)		5 (3.49%)	11.11
Gastrointestinal diseases and diabetes	1 (33.33%)	2 (66.67%)		3 (2.10%)	8.82
Ophthalmology	2 (100%)	0		2 (1.40%)	9.52
Pulmonology	1 (100%)	0		1 (0.70%)	12.5
Dermatology	2 (100%)	0		2 (1.40%)	15.38
Others (XCGD, enzyme deficiency)	3 (100%)	0		3 (2.09%)	17.64
Total	91 (63.63%)	43 (30.06%)	9 (6.30%)	143 (100%)	–
Discontinuation rate per phase	23.04%	26.54%	23.68%	–	–

This table shows the number of discontinued trials by phase and therapeutic area.

Table 3. Rate of discontinuation by sponsor status

	Discontinued trials	Ongoing and completed trials	Total	Rate of discontinuation (%)
Commercial sponsors	38 (26.57%)	117 (24.68%)	155 (25.12%)	24.52
Non-commercial sponsors	105 (73.43%)	357 (75.32%)	462 (74.88%)	22.73
Universities	48 (45.71%)	136 (38.10%)	184 (39.83%)	26.09
Hospitals	11 (10.48%)	114 (31.93%)	125 (27.06%)	8.80
Institutes	32 (30.48%)	57 (15.97%)	89 (19.26%)	35.95
Medical centers	11 (10.48%)	32 (8.96%)	43 (9.31%)	25.58
Government	3 (2.86%)	18 (5.04%)	21 (4.54%)	14.28
Total	143 (23.18%)	474 (76.82%)	617 (100%)	23.18

This table shows the number of discontinued, ongoing and completed trials and the rate of discontinuation by sponsor status.