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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 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 CONCLUSION:One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2?years post-FDA approval.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.

SUBMITTER: Omae K

PROVIDER: S-EPMC6814120 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation.

Omae Kenji K Kataoka Yuki Y Tsujimoto Yasushi Y Tsutsumi Yusuke Y Yamamoto Yosuke Y Fukuhara Shunichi S Furukawa Toshi A TA

BMC cancer 20191024 1

<h4>Background</h4>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).<h4>Methods</h4>We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed ...[more]

PMID: 31651263

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Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation.

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Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation.

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