Publication and data sharing of completed NCI cooperative group trials.

Abstract

11023 Background: Concerns about timely publication of NIH trial results, as well as sharing of clinical trial data, have led to important initiatives. The NCI developed an online archive of individual patient data (IPD) for cooperative group trials published after 2014, and ClinicalTrials.gov has required data sharing plans for all trials that began enrollment after 2018. We examined the dissemination of NCI cooperative group trial results via published manuscripts as well as availability of IPD from completed trials. Methods: We queried the Access to Aggregate Content of ClinicalTrials.gov database for phase II or III interventional trials for which NCI cooperative groups were listed as the sponsor, responsible party, or principal investigator. We included trials that were initiated between 2011 and 2022 and reached actual primary completion status (i.e. completion of data collection to fulfill the primary outcome measurement) by 2022. Primary manuscripts that reported the study primary outcome data were identified by searching NCT ID numbers on ClinicalTrials.gov, PubMed, and Google Scholar through a dual review. We restricted our 2 and 5-year assessments of study publication status to studies that had reached their primary completion date before 2022 and 2019, respectively. Individual patient data (IPD) sharing was assessed by reviewing the data-sharing statements on ClinicalTrials.gov for trials that began enrollment after the ClinicalTrials.gov mandate in January 2019. Next, we searched the NCT trial number in the NCTN/NCORP data archive to look for the availability of IPD among trials that published their primary outcome after January 2015. We also conducted a subgroup analysis of phase III trials. Results: Of 232 eligible studies, 159 (68.5%) were phase II, 11 (4.7%) were phase II/III, and 62 (26.7%) were phase III. NRG Oncology (n=58), Eastern Cooperative Oncology Group (n=47), and Alliance for Clinical Trials in Oncology (n=42) were the most represented cooperative groups. Overall, 33 (14.2% of the total) trials published their primary outcome results within one year of their primary completion, compared to 67 (31.6%) within 2 years, and 69 (63.3%) in 5 years. Among phase III trials, 26 (44.8%) had published their primary outcome findings within 2 years of study completion, and 22 (78.6%) published within 5 years. Among the 138 trials that published their primary outcome since January 2015, 36 (26.1%) had their IPD stored in the NCI online archive (76.1% of the 46 phase III trials). Among the 9 trials initiated since January 2019, 3 indicated on ClinicalTrials.gov that they had a plan to share their IPD. Conclusions: A substantial proportion of NCI cooperative group trials have not published manuscripts reporting their primary results in a peer-reviewed journal within 5 years of study completion. Approximately three quarters of phase III group trials completed during the study period had their IPD available within the NCI archive.