November 4, 2019Oncology
According to an article published in JAMA Network Open, it was shown that nearly half of phase 3 cancer clinical trials carried out by the SWOG Cancer Research Network, part of the NCI's National Clinical Trials Network (NCTN) were associated with clinical care guidelines or new drug approvals. The study suggests that the studies added value regardless of whether findings were positive or negative. In addition, the authors found that the cost of an FDA approval using an NCTN trial was much less than the cost of an FDA approval from a trial run by pharmaceutical companies.
SWOG Cancer Research Network is a part of the nation's oldest and largest publicly funded cancer research network. Texas pediatrician Grant Taylor, MD, founded the group in Houston in 1956 under a new National Cancer Institute (NCI) program aimed at testing childhood cancer treatments through regional networks of physicians. The original name - the Southwest Cancer Chemotherapy Study Group, later become the Southwest Oncology Group, which was shortened to SWOG. Finally, in 2018, the program was named SWOG Cancer Research Network, which is now one of five groups in the NCTN.
The study used data from 182 phase 3 trials enrolling 148,028 patients between 1980 and 2017. These included trials that were led by SWOG or that were led by other NCTN groups with SWOG participation. According to the analysis, 82 of the 182 trials, or 45%, were found to be practice influential, meaning that they influenced cancer care, either by being reflected in the National Comprehensive Cancer Network (NCCN) clinical guidelines or by being associated with a new drug approval by the FDA. Of those 82 practice-influential trials, 70 influenced NCCN guidelines, six influenced new FDA drug approvals, and six influenced both.
Interestingly, the influence of negative trial results on cancer care seen in this study surprised the authors. Of the 82 practice-influential trials identified, 35, or 43%, had negative findings, with nearly half of those 35 trials reaffirming standard of care compared with experimental therapies being tested in the trials. Such negative findings signal to the oncology community which new, and potentially expensive, drugs are not effective. Negative trials can also reveal harmful side effects caused by experimental therapies.
The authors also sought to estimate the costs of the trials in the study and looked at differences in costs of getting FDA approvals between the publicly funded trials in the study and privately funded trials conducted by pharmaceutical companies, biotech firms, and other industry funders. They estimated that total federal investment supporting the trials in the study was $1.36 billion. This suggests that for 182 trials, average costs were $7.5 million per completed phase 3 trial (all trials), $16.6 million per practice-influential trial, and $123.6 million per new drug approval. In a review of 10 studies of the cost of new drug approvals by industry, the authors found that the mean inflation-adjusted cost for a single new drug approval was $1.73 billion. The study authors wrote that this kind of cost comparison is imperfect because pharmaceutical company trials can be more expensive, in part because of regulatory costs. Still, this comparison highlights the value of the NCTN program for taxpayers and the patients and families that benefit.
According to the authors, the take-home message from the study is that NCTN studies provide a lot of clinically meaningful evidence for patients that influences their care routinely and does so at a relatively cost-effective level, and that it is important that people appreciate just how valuable these trials are in terms of benefit to patients with cancer.