Evidence Strength of Pharmaceutical Industry-Funded Clinical Trials in Metastatic NSCLC: A Comparison With Other Sources of Funding.

INTRODUCTION: Clinical trials are expensive and often require funding from the pharmaceutical industry (PI). We aimed to compare studies funded by the PI with those funded by other sources in terms of costs, reported results, and strength of evidence. METHODS: We searched PubMed for clinical trial reports on metastatic NSCLC published between 2012 and 2017. We divided all the studies into two groups: studies funded by the PI and those funded by other sources. The primary end point was to compare the evidence strength of each group. The secondary end points were to compare the number of patients included, the number and costs of innovative drugs studied, whether there was preferential reporting of positive results in the experimental arm, and the risk of bias. RESULTS: We found 3004 studies, and of these, we analyzed 477 studies (275 sponsored by the PI and 202 funded by other sources). A total of 85,328 patients overall were included (64,434 in studies sponsored by the PI and 20,894 in studies with other funding sources; p < 0.001). The studies funded by the PI had stronger evidence (p < 0.001), evaluated more innovative therapies (72% versus 36%; p < 0.001), and resulted in a higher proportion of open-access manuscripts (63% versus 47%; p < 0.001). There was no considerable difference regarding the reporting of experimental arm superiority or the risk of bias between the two groups. CONCLUSIONS: Compared with studies from other sources of funding, those funded by the PI in the lung cancer field collected stronger evidence, assessed more expensive and innovative therapies, and seemed to equally emphasize positive and negative results.

A paradigm shift for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer: a review of CDK inhibitors.

In the last 3 years, a novel class of targeted therapy has been approved for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. There are currently three approved agents, which are oral cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. All of the approved drugs exhibit progression-free survival benefit when compared to standard of care and generally have less adverse events compared to traditional chemotherapeutic options. The treatment of HR+/HER2- advanced breast cancer is a continuously evolving landscape, and the addition of CDK4/6 inhibitors is the newest mechanism for treatment. In this review, we summarize all available data, highlight the unanswered questions, and discuss pharmacological differences between each CDK4/6 inhibitor.