Supplemental Table S7 from Secondary Endpoint Utilization and Publication Rate among Phase III Oncology Trials

Beck, Esther J.; Sherry, Alexander D.; Florez, Marcus A.; Kouzy, Ramez; Abi Jaoude, Joseph; Lin, Timothy A.; Miller, Avital M.; Passy, Adina H.; Kupferman, Gabrielle S.; Patel, Roshal R.; Chino, Fumiko; Higbie, Victoria Serpas; Parseghian, Christine M.; Overman, Michael J.; Minsky, Bruce D.; Thomas, Charles R.; Tang, Chad; Msaouel, Pavlos; Ludmir, Ethan B.

doi:10.1158/2767-9764.26788839.v1

Supplemental Table S7 from Secondary Endpoint Utilization and Publication Rate among Phase III Oncology Trials

journal contribution

posted on 2024-08-20, 09:20 authored by Esther J. Beck, Alexander D. Sherry, Marcus A. Florez, Ramez Kouzy, Joseph Abi Jaoude, Timothy A. Lin, Avital M. Miller, Adina H. Passy, Gabrielle S. Kupferman, Roshal R. Patel, Fumiko Chino, Victoria Serpas Higbie, Christine M. Parseghian, Michael J. Overman, Bruce D. Minsky, Charles R. Thomas, Chad Tang, Pavlos Msaouel, Ethan B. Ludmir

Full multivariable model evaluating the association between the number of SEPs and the percentage of SEPs published among sensitivity analysis SEPs from both the protocol and ClinicalTrials.Gov, from trials with multiple protocols available.

History

ARTICLE ABSTRACT

Secondary endpoints (SEP) provide crucial information in the interpretation of clinical trials, but their features are not yet well understood. Thus, we sought to empirically characterize the scope and publication rate of SEPs among late-phase oncology trials. We assessed SEPs for each randomized, published phase III oncology trial across all publications and ClinicalTrials.gov, performing logistic regressions to evaluate associations between trial characteristics and SEP publication rates. After screening, a total of 280 trials enrolling 244,576 patients and containing 2,562 SEPs met the inclusion criteria. Only 22% of trials (62/280) listed all SEPs consistently between ClinicalTrials.gov and the trial protocol. The absolute number of SEPs per trial increased over time, and trials sponsored by industry had a greater number of SEPs (median 9 vs. 5 SEPs per trial; P < 0.0001). In total, 69% of SEPs (1,770/2,562) were published. The publication rate significantly varied by SEP category [X2 (5, N = 2,562) = 245.86; P < 0.001]. SEPs that place the most burden on patients, such as patient-reported outcomes and translational correlatives, were published at 63% (246/393) and 44% (39/88), respectively. Trials with more SEPs were associated with lower overall SEP publication rates. Overall, our findings are that SEP publication rates in late-phase oncology trials are highly variable based on the type of SEP. To avoid undue burden on patients and promote transparency of findings, trialists should weigh the biological and clinical relevance of each SEP together with its feasibility at the time of trial design. In this investigation, we characterized the utilization and publication rates of SEPs among late-phase oncology trials. Our results draw attention to the proliferation of SEPs in recent years. Although overall publication rates were high, underpublication was detected among endpoints that may increase patient burden (such as translational correlatives and patient-reported outcomes).