HCR 593 Module 12 Applied Project Final Research Paper Example

Half on Time: How Quickly Sponsors of Late-Phase Drug Trials Completed in 2021 and 2022 Submitted Results

Student Name

MS in Clinical Research Management, Arizona State University

HCR 593: Applied Project

Instructor Name

Month Day, Year

Half on Time: How Quickly Sponsors of Late-Phase Drug Trials Completed in 2021 and 2022 Submitted Results

Abstract

Background: Sponsors of applicable trials must file summary results on ClinicalTrials.gov, in most cases no more than a year after primary completion. Objective: To measure results-submission timeliness for recent late-phase drug trials. Methods: Registry records downloaded October 10, 2026, covering completed interventional Phase 3 and 4 drug trials with a U.S. site and primary completion in 2021 or 2022. Results: Of 1,239 trials, 583 (47.1%; 95% CI, 44.3% to 49.8%) submitted results within 365 days and 1,093 (88.2%) at any time. Industry sponsors submitted on time more often than others (52.1% versus 41.9%; p < .001). Conclusion: Timeliness has improved since earlier studies but more than half of recent late-phase drug trials still miss the one-year mark.

Introduction

Results reporting protects the value of trial participants' contributions and corrects for incomplete journal publication (Ross et al., 2012). Under the 2016 final rule most applicable trials have one year to submit (Zarin et al., 2016), as the regulation itself states (42 C.F.R. § 11.44). Studies found that 13.4% of trials completed from 2008 to 2012 reported within a year (Anderson et al., 2015) and 40.9% of trials due by 2019 submitted on time (DeVito et al., 2020). This study extends the measurement to trials whose primary completion fell in 2021 or 2022.

Methods

Data and Sample

Records were retrieved from the ClinicalTrials.gov application programming interface on October 10, 2026. Records qualified if they were interventional, Phase 3 or 4, marked completed, had a U.S. site and a drug intervention and listed primary completion between January 1, 2021, and December 31, 2022. The search returned 1,239 trials.

Outcomes and Variables

The primary outcome was submission of results within 365 days of the primary completion date, using the registry's results first-submitted date. The secondary outcome was any submission by the access date. Sponsor class was industry or non-industry. Primary completion year was 2021 or 2022.

Analysis

Each proportion carries a Wilson 95% interval, and group differences were tested by chi-square. Median days from primary completion to submission were calculated for trials with results.

Results

Industry sponsors were more likely than others to submit within a year (chi-square 12.86, p < .001) and to submit at all (chi-square 21.0, p < .001). Timeliness did not differ between completion years (chi-square 0.34, p = .56). The median time from primary completion to submission was 365 days overall, 364 for industry and 366 for other sponsors. By contrast, only 12.2% of trials had results posted publicly within a year, reflecting the time taken by quality review after submission.

Discussion

Just under half of recent late-phase drug trials submitted results within a year, higher than the 40.9% reported for trials due by 2019 (DeVito et al., 2020) and far higher than the 13.4% found for 2008 to 2012 (Anderson et al., 2015). The median submission time sits almost exactly at the deadline, which suggests that many sponsors treat the deadline as a target rather than a ceiling and that small delays push many trials just past it. The industry advantage persists, consistent with every earlier study, though the gap is smaller than the odds ratio of about three reported for 2018 and 2019.

Comparisons with earlier studies must be cautious. This sample is restricted to completed Phase 3 and 4 drug trials with U.S. sites, which the law more probably covers and which tend to have more experienced sponsors than the broader samples studied before. Part of the apparent improvement may reflect the sample rather than a change in behavior.

Limitations

The registry fields used do not identify trials with certifications that legitimately delay submission or trials not covered by the law, so the 365-day measure is a proxy for compliance, not a legal determination. The sample excludes terminated trials and those without U.S. sites. Sponsor class is broad and does not distinguish large from small sponsors, a factor earlier work found important.

Recommendations

Conclusion

Results submission for recent late-phase drug trials is better than in earlier years but still on time for fewer than half of trials, with non-industry sponsors lagging. Building reporting into trial close-out plans, rather than treating the deadline as a target, would move the median comfortably inside the one-year limit.

References

Anderson, M. L., Chiswell, K., Peterson, E. D., Tasneem, A., Topping, J., & Califf, R. M. (2015). Compliance with results reporting at ClinicalTrials.gov. New England Journal of Medicine, 372(11), 1031-1039. https://doi.org/10.1056/NEJMsa1409364

Clinical trials registration and results information submission, 42 C.F.R. § 11.44 (2025).

DeVito, N. J., Bacon, S., & Goldacre, B. (2020). Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: A cohort study. The Lancet, 395(10221), 361-369. https://doi.org/10.1016/S0140-6736(19)33220-9

Ross, J. S., Tse, T., Zarin, D. A., Xu, H., Zhou, L., & Krumholz, H. M. (2012). Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ, 344, d7292. https://doi.org/10.1136/bmj.d7292

Zarin, D. A., Tse, T., Williams, R. J., & Carr, S. (2016). Trial reporting in ClinicalTrials.gov: The final rule. New England Journal of Medicine, 375(20), 1998-2004. https://doi.org/10.1056/NEJMsr1611785