Industry-sponsored studies had higher translated-consent availability (51.4% vs 23.9% of events; OR 3.4) than non-industry studies

Description #

Translated consent documents were less available in non-industry-sponsored studies. The proportion of consent events occurring in studies that had at least one translated consent document available was 51.4% for industry-sponsored studies versus 23.9% for non-industry-sponsored studies (P < 0.001). Expressed as odds, a consent event in an industry-sponsored study had roughly 3.4-fold higher odds of having any translated consent document available (Extended Data Table 3).

"Yet, the proportion of consent events in studies that had translated consent documents available was higher for industry-sponsored studies compared with those not sponsored by industry (51.4% versus 23.9%, P < 0.001)." (Maria, 2023, p. 857)

"The odds of a consent event for an industry-sponsored study having any available translated consent documents were greater than that for a non-industry-sponsored study (odds ratio (OR) 3.4, 95% confidence interval (CI) 3.1 to 3.6, P < 0.001; data not shown)." (Maria, 2023, p. 857)

Methods Context #

What? #ⓘ

The observable: whether the study for a given consent event had any IRB-approved translated consent document available, compared by sponsor type.

"Studies with at least one translated consent document, N (% per sponsor type)" (Maria, 2023, Extended Data Table 3)

How? #ⓘ

Chart/database review of all consent events; sponsor labelled from principal funding sponsor; odds estimated by GEE logistic regression clustered by patient.

"Studies considered to be industry sponsored had a biopharmaceutical company that evaluated a drug, device or procedure serve as the principal funding sponsor. All other studies were considered non-industry sponsored." (Maria, 2023, Methods)

Who? #ⓘ

All 12,082 consent events across 758 studies (585 industry, 173 non-industry) at one cancer centre, 2013–2018.

"Nearly half of consent events (n = 5,738) were for industry-sponsored studies (Extended Data Table 3)." (Maria, 2023, p. 856)

Other Notes #

The 51.4% vs 23.9% is a consent-event-level proportion; Extended Data Table 3 additionally reports the study-level split (industry 222/585 = 38% vs non-industry 39/173 = 23% of studies with ≥1 translated document, P < 0.001).

Caveats #

• Retrospective single-centre EHR-based cohort that cannot establish causation (Maria 2023) The associations come from a retrospective, single-centre analysis built on electronic health record and clinical-trials-database data at one academic cancer centre. A retrospective design cannot prove causation; the single-centre setting limits generalizability (sensitivities around patient health information, study-related data, and regulatory differences make cross-centre replication difficult); and key variables were captured retrospectively and may be inaccurate — Medi-Cal insurance status is dynamic and may not reflect status at the consent event, and language information may not be documented accurately in the EHR. The authors argue that consistent associations across analyses support the hypothesis, but the estimates remain observational.