Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
Abstract Background The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials supporting recent anticancer drugs a...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-10-01
|
| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-019-6232-x |
| _version_ | 1818340546966454272 |
|---|---|
| author | Kenji Omae Yuki Kataoka Yasushi Tsujimoto Yusuke Tsutsumi Yosuke Yamamoto Shunichi Fukuhara Toshi A. Furukawa |
| author_facet | Kenji Omae Yuki Kataoka Yasushi Tsujimoto Yusuke Tsutsumi Yosuke Yamamoto Shunichi Fukuhara Toshi A. Furukawa |
| author_sort | Kenji Omae |
| collection | DOAJ |
| description | Abstract Background The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials supporting recent anticancer drugs approved by the FDA, with a focus on immune checkpoint inhibitors (ICPis). Methods We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed the clinical trials performed for each drug indication and matched each trial with publications in the literature. The primary benchmark was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model that was adjusted for clustering within drug indications and individual covariates. Results Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in the time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8–1.7; P = 0.55). However, findings related to non-ICPis investigated specifically in randomized phase 2 or phase 3 trials were significantly more likely to be published earlier than those related to ICPis (adjusted HR, 7.4; 95% CI, 1.8–29.5; P = 0.005). Conclusion One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2 years post-FDA approval. We found no evidence that the drug type was associated with the time to overall trial publication. |
| first_indexed | 2024-12-13T15:44:38Z |
| format | Article |
| id | doaj.art-0df9771dda684037b3f6a6d0e8dc801e |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-13T15:44:38Z |
| publishDate | 2019-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-0df9771dda684037b3f6a6d0e8dc801e2022-12-21T23:39:43ZengBMCBMC Cancer1471-24072019-10-0119111010.1186/s12885-019-6232-xPublication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigationKenji Omae0Yuki Kataoka1Yasushi Tsujimoto2Yusuke Tsutsumi3Yosuke Yamamoto4Shunichi Fukuhara5Toshi A. Furukawa6Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University HospitalDepartment of Healthcare Epidemiology, Kyoto University School of Public Health in the Graduate School of MedicineDepartment of Healthcare Epidemiology, Kyoto University School of Public Health in the Graduate School of MedicineDepartment of Healthcare Epidemiology, Kyoto University School of Public Health in the Graduate School of MedicineDepartment of Healthcare Epidemiology, Kyoto University School of Public Health in the Graduate School of MedicineDepartment of Healthcare Epidemiology, Kyoto University School of Public Health in the Graduate School of MedicineDepartment of Health Promotion and Human Behavior, Kyoto University School of Public Health in the Graduate School of MedicineAbstract Background The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials supporting recent anticancer drugs approved by the FDA, with a focus on immune checkpoint inhibitors (ICPis). Methods We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed the clinical trials performed for each drug indication and matched each trial with publications in the literature. The primary benchmark was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model that was adjusted for clustering within drug indications and individual covariates. Results Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in the time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8–1.7; P = 0.55). However, findings related to non-ICPis investigated specifically in randomized phase 2 or phase 3 trials were significantly more likely to be published earlier than those related to ICPis (adjusted HR, 7.4; 95% CI, 1.8–29.5; P = 0.005). Conclusion One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2 years post-FDA approval. We found no evidence that the drug type was associated with the time to overall trial publication.http://link.springer.com/article/10.1186/s12885-019-6232-xAnticancer drugsClinical trialsDrug approvalImmune checkpoint inhibitorsPublicationsUnited states food and drug administration |
| spellingShingle | Kenji Omae Yuki Kataoka Yasushi Tsujimoto Yusuke Tsutsumi Yosuke Yamamoto Shunichi Fukuhara Toshi A. Furukawa Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation BMC Cancer Anticancer drugs Clinical trials Drug approval Immune checkpoint inhibitors Publications United states food and drug administration |
| title | Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation |
| title_full | Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation |
| title_fullStr | Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation |
| title_full_unstemmed | Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation |
| title_short | Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation |
| title_sort | publication statuses of clinical trials supporting fda approved immune checkpoint inhibitors a meta epidemiological investigation |
| topic | Anticancer drugs Clinical trials Drug approval Immune checkpoint inhibitors Publications United states food and drug administration |
| url | http://link.springer.com/article/10.1186/s12885-019-6232-x |
| work_keys_str_mv | AT kenjiomae publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation AT yukikataoka publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation AT yasushitsujimoto publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation AT yusuketsutsumi publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation AT yosukeyamamoto publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation AT shunichifukuhara publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation AT toshiafurukawa publicationstatusesofclinicaltrialssupportingfdaapprovedimmunecheckpointinhibitorsametaepidemiologicalinvestigation |