Year: 2026
Type: preprint
Study design: Observational Study
Abstract: Background In 2018, the US National Institutes of Health (NIH) created a dedicated clinical trial pathway for K23 career development awards, and its planned KC1 award will not fund trial conduct for applications due from late 2027. Whether the pathway changed how many awardees led trials, or which trials, is unknown. We assessed leadership of the trial the award supported (K trial), of distinct new trials, and of any trial. Methods and findings In this cohort study of 1847 K23 awardees (fiscal years 2014 to 2021; 837 under the pathway), we linked NIH award records to ClinicalTrials.gov registrations, including archived versions. A difference-in-differences design, adjusted for fiscal year and NIH funding institute, compared awardees whose funded abstracts proposed their own trial (trial plans; n = 721) with other awardees. A language model measured trial plans and leadership, and author review of 280 sampled records corrected its errors. Before correction, 54.4% of earlier and 73.1% of pathway awardees with trial plans led a K trial within 5 years, vs 4.1% and 5.1% of others. This gap widened by 18.6 percentage points uncorrected and 13.7 (95% CI, 5.7-21.2) corrected, mostly in grant-citing trials. The new-trial gap changed by − 3.8 (95% CI, − 14.4 to 6.9). Assuming parallel trends, every correction excluded gains above 11.5 points (earlier rate, 37.6%). The any-trial gap widened by 4.2 (95% CI, − 5.9 to 14.0) when correction probabilities were estimated separately by period and 9.6 (95% CI, 1.5-17.9) when they were pooled across periods. Had early-cohort trends (2.4 points yearly) continued, the K-trial estimate would be 4.1 (95% CI, − 17.7 to 26.8). Limitations include more complete registration after concurrent NIH application changes, which the design cannot separate from the pathway, and selection among funded awardees. Conclusions The dedicated pathway was associated with more awardees with trial plans leading their award-supported trial, although more complete registration or an earlier trend could not be ruled out. New-trial leadership within 5 years did not detectably increase, and whether the pathway produced more trial leaders is unclear. Evaluations of KC1 should track proposed and new trials separately. Author summary Why was this study done? The US National Institutes of Health (NIH) trains clinician investigators through K23 career development awards. In 2018, NIH split these awards into a pathway that required applicants to propose leading their own clinical trial and one that did not allow it. NIH will consolidate its clinician K awards into a single KC1 award for applications due from late 2027, and KC1 funds cannot pay for trials, yet little is known about what the dedicated pathway did. What did the researchers do and find? We followed 1847 K23 awardees for 5 years in ClinicalTrials.gov, comparing awardees whose funded plans proposed their own trial with other awardees before and after the pathway, and corrected language-model measurements with author review of 280 records. In registry records, more awardees with trial plans led the trial their award supported after the pathway (73.1% vs 54.4% before correction); after correction, the gap with other awardees widened by 13.7 percentage points (95% CI, 5.7-21.2). Leadership of distinct new trials did not detectably increase, and whether more awardees led any trial depended on an assumption about measurement error. The increase came mostly from registrations citing the K grant, and more complete registration after concurrent NIH changes or a continuing earlier trend could not be ruled out. What do these findings mean? A dedicated trial pathway coincided with more awardees leading their award-supported trial, but not with detectably more awardees leading new trials within 5 years of award start. In uncorrected registry records, 69.9% of the 346 pathway awardees with trial plans had started a K trial and 39.6% had one recorded as completed within 5 years, a baseline for evaluating KC1. Because KC1 awards cannot fund trials, registry grant citations may no longer identify awardees’ trials; evaluations should record each trial’s funder and whether the award plan proposed it, and follow awardees for 7 years.
Authors: Haining Wang, Hengyi Fu, Zuoyu Tian
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7221686340