Common Clinical Trial Amendments, why they are submitted and how they can be avoided: a mixed methods study on NHS UK Sponsored Research (Amendments Assemble)

Table 1 Summary of trial characteristics further split by those with and without an amendment submitted

	Trials with amendments submitted (n = 53) n(%)	Trials with no amendments submitted (n = 47) n(%)	All included trials (n = 100) n(%)
Trial status
Open to recruitment^a	32(60)	21(40)	53(53)
Closed to recruitment	21(47)	24(53)	45(45)
Not started recruitment	0(0)	2(100)	2(2)
Trial design
Observational	37(51)	36(49)	73(73)
Non-randomised intervention	2(40)	3(60)	5(5)
Randomised control trial (RCT)^b	14(64)	8(36)	22(22)
Trial funder
Commercial	8(89)	1(11)	9(9)
Non-commercial	28(82)	6(18)	34(34)
Not funded	10(34)	19(66)	29(29)
Not known	7(25)	21(75)	28(28)

^aThis includes trials where it was not clear if the study had closed, so was assumed to still be open to recruitment; it also includes those trials subsequently known to have paused recruitment due to the COVID-19 pandemic
^bA total of 4 are CTIMPs, and all 4 had amendments submitted

ISSN: 1745-6215