Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

Gopal, Anand D.; Wallach, Joshua D.; Aminawung, Jenerius A.; Gonsalves, Gregg; Dal-Ré, Rafael; Miller, Jennifer E.; Ross, Joseph S.

doi:10.1186/s13063-018-2825-y

Trials

Table 3 Registration, timeliness of registration, primary outcome concordance, and study results across clinical trials published in 10 high-impact US medical specialty society journals, stratified by trial characteristics

From: Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

	Total (column %)	Registration		Timeliness of registration^{c, d}				Primary outcome Comparison^{g, h}		Primary outcome Resultsⁱ
	Total (column %)	Unregistered (%)^b	RR (95% CI); chi-squared p value	Retrospective (%)^e	RR (95% CI); chi-squared p value	Retrospective after initial primary outcome ascertainment (%) ^{e, f}	RR (95% CI); chi-squared p value	Non-discordant (%)^e	RR (95% CI); chi-squared p value	Favorable (%)^j	RR (95% CI); chi-squared p value
Total	486 (100)	47 (9.7)		99 (22.6)		67 (15.3)		249 (56.7)		282 (66.4)
Drug/device/ biological
Yes	392 (80.7)	31 (7.9)	0.46 (0.27–0.81); 0.0073	65 (18.0)	0.42 (0.30–0.58); < 0.001	42 (11.6)	0.37 (0.24–0.57); < 0.001	216 (59.8)	1.36 (1.05–1.77); 0.009	218 (64.7)	0.89 (0.77–1.03); 0.16
No	94 (19.3)	16 (17.0)	0.46 (0.27–0.81); 0.0073	34 (43.6)	0.42 (0.30–0.58); < 0.001	25 (32.1)	0.37 (0.24–0.57); < 0.001	33 (42.3)	1.36 (1.05–1.77); 0.009	64 (72.7)	0.89 (0.77–1.03); 0.16
Funding^a
Industry	216 (44.4)	11 (5.1)	0.38 (0.20–0.73); 0.0023	25 (12.2)	0.39 (0.26–0.58); < 0.001	18 (8.8)	0.41 (0.25–0.68); < 0.001	131 (63.9)	1.22 (1.04–1.42); 0.014	117 (65.7)	0.98 (0.86–1.13); 0.82
Non-industry	270 (55.6)	36 (13.3)	0.38 (0.20–0.73); 0.0023	74 (31.6)	0.39 (0.26–0.58); < 0.001	49 (20.9)	0.41 (0.25–0.68); < 0.001	118 (50.4)	1.22 (1.04–1.42); 0.014	165 (66.8)	0.98 (0.86–1.13); 0.82
Location
≥ 1 US site	250 (51.4)	15 (6.0)	0.44 (0.25–0.80); 0.0048	35 (14.9)	0.47 (0.33–0.68); < 0.001	23 (9.8)	0.44 (0.28–0.71); < 0.001	133 (56.6)	0.94 (0.80–1.10); 0.44	148 (65.8)	0.98 (0.86–1.12); 0.79
Non-US	236 (48.6)	32 (13.5)	0.44 (0.25–0.80); 0.0048	64 (31.4)	0.47 (0.33–0.68); < 0.001	44 (21.6)	0.44 (0.28–0.71); < 0.001	116 (56.9)	0.94 (0.80–1.10); 0.44	134 (67.0)	0.98 (0.86–1.12); 0.79
Randomized
Yes	372 (76.5)	23 (6.2)	0.29 (0.17–0.50); < 0.001	79 (22.6)	1.02 (0.66–1.58); 0.91	56 (16.0)	1.30 (0.71–2.36); 0.39	195 (55.9)	0.85 (0.72–1.02); 0.10	231 (64.0)	0.80 (0.69–0.93); 0.01
No	114 (23.5)	24 (21.1)	0.29 (0.17–0.50); < 0.001	20 (22.2)	1.02 (0.66–1.58); 0.91	11 (12.2)	1.30 (0.71–2.36); 0.39	54 (60)	0.85 (0.72–1.02); 0.10	51 (79.7)	0.80 (0.69–0.93); 0.01
Enrollment
≥ 100	280 (57.6)	9 (3.2)	0.17 (0.09–0.35); < 0.001	58 (21.4)	0.88 (0.62–1.25); 0.49	43 (15.9)	1.10 (0.69–1.74); 0.69	162 (59.8)	1.06 (0.90–1.25); 0.47	161 (62.7)	0.87 (0.76–0.99); 0.046
< 100	206 (42.4)	38 (18.5)	0.17 (0.09–0.35); < 0.001	41 (24.4)	0.88 (0.62–1.25); 0.49	24 (14.3)	1.10 (0.69–1.74); 0.69	87 (51.8)	1.06 (0.90–1.25); 0.47	121 (72.0)	0.87 (0.76–0.99); 0.046

^aTrials receiving either full or partial industry support were designated as having received industry funding
^bPercentages are expressed as the fraction of total trials in each row
^cTrials registered > 30 days after enrollment start were considered to have been registered retrospectively. Note that ICMJE policy mandates registration prior to enrollment start
^dAmong 439 registered trials, we could not determine timeliness of registration for 2 (1 published in Gastroenterology and the other in Journal of Clinical Oncology), as enrollment start date was missing from registrations. We excluded these 2 trials from analyses of association pertaining to overall timeliness of registration and timelines of registration relative to initial primary outcome ascertainment
^ePercentages are expressed as the fraction of registered trials (total −kindly advise if my minus sign inclusion here is correct; please alter as need if not unregistered) in each row
^fDue to the nature of the primary outcome (i.e., median survival), we could not determine if retrospective registration occurred after initial primary outcome ascertainment in 8 cases: 1 in Blood; 1 in Hepatology; 2 in Journal of Allergy and Clinical Immunology; and 4 in Journal of Clinical Oncology. These trials were excluded from analyses of association pertaining to timeliness of registration relative to initial primary outcome ascertainment
^gRegistered and published primary outcomes were considered non-discordant if they did not explicitly differ in any of the following 3 domains: number of outcomes, outcome definition(s), or outcome time frame(s)
^h26 of 439 registered trials did not have a primary outcome designated in their publication and were, therefore, excluded from analyses of association pertaining to primary outcome comparison
ⁱPrimary outcome favorability could not be judged for 61 trials. These trials were excluded from analyses of association pertaining to primary outcome favorability
^jPercentages are expressed as the fraction of trials in each row for which primary outcome favorability could be judged (row totals not shown)
Abbreviations: RR relative risk, CI confidence interval

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ISSN: 1745-6215

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