Spotlight

This month we have chosen to highlight the posting of informed consent forms (ICFs) on clinicaltrials.gov by industry funded trials. In the American Association of Pharmaceutical Scientists Journal article ‘Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis’ Dal-Ré and Mahillo-Fernández advocate for a new regulatory standard requiring the posting of ICFs. The authors found that of 116,281 industry funded trials only 741, or 0.6%, posted their ICFs on clinicaltrials.gov. We note from other ongoing work undertaken by the Center for Informed Consent Integrity that there are currently over 9,000 ICFs posted, making the 741 available from industry funded trials even more striking.

The article finds that when industry sponsors do make their ICFs available, they are highly compliant with transparency standards, seemingly having found a resolution to the general objection from commercial organizations that the posting of ICFs would reveal trade secrets and/or ongoing research programs. These findings raise questions about how to increase the availability of ICFs and enhance shared learning across the field of informed consent.

Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis
Rafael Dal-Ré, Ignacio Mahillo-Fernández
American Association of Pharmaceutical Scientists Journal, 18 June 2024; 26(4)
Abstract
We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as ‘sponsor’ or ‘collaborator’ could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as ‘sponsor’ or ‘collaborator’ was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as ‘completed’ (n = 408) or ‘terminated’ (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as ‘collaborator’ were significantly more likely to post ICFs when trials were in the ‘active, not recruiting’ phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as ‘sponsors’ were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as ‘collaborators’. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.