September 2019. A new study shows that nearly half of phase 3 cancer clinical
trials carried out by the National Cancer Institute (NCI)-sponsored SWOG Cancer
Research Network, one of five groups in NCI’s National Clinical Trials
Network (NCTN), were associated with clinical care guidelines or new
drug approvals. NCI is part of the National Institutes of Health.
was published in JAMA
Network Open and conducted by researchers affiliated with SWOG from several institutions around the country.
The study suggests that NCTN trials add value regardless of whether findings
were positive or negative. In addition, the authors calculated the cost of
running NCTN trials, and they also found that the cost of a U.S. Food and Drug
Administration approval from an NCTN trial was much less than the cost of an
FDA approval from a trial run by pharmaceutical companies.
that the NCTN program contributes clinically meaningful, cost-effective
evidence to guide care of cancer patients,” said Joseph Unger, Ph.D., a health
services researcher and biostatistician for SWOG at the Fred Hutchinson Cancer
Research Center, Seattle, and lead author of the study. “These trials are
largely funded by the public, which is getting good value for their
researchers 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
funded cancer treatment trials fill an important gap in clinical research by
seeking answers to treatment questions that might not otherwise be explored,”
said James Doroshow, M.D., director of NCI’s Division of Cancer Treatment and
Diagnosis, which oversees the NCTN. “This study sheds light on the critical
role these trials have in guiding clinical cancer treatment, whether the
findings from the trials are positive or negative.”
In fact, the
influence of negative trial results on cancer care seen in this study surprised
the researchers. 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.
researchers 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.
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 researchers found that the mean
inflation-adjusted cost for a single new drug approval was $1.73 billion.
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
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,” he said. “It’s
important that people appreciate just how valuable these trials are in terms of
benefit to patients with cancer.”
study was supported by the NIH through the and by The Hope Foundation for
Dr. Unger, the research team includes Van T. Nghiem, Ph.D., of the SWOG
Statistics and Data Management Center and Fred Hutchinson; Dawn L. Hershman,
M.D., of NewYork-Presbyterian/Columbia University Irving Medical Center; Riha
Vaidya, Ph.D., of the SWOG Statistics and Data Management Center and Fred
Hutchinson; Michael LeBlanc, Ph.D., of the SWOG Statistics and Data Management
Center and Fred Hutchinson, the SWOG group statistician; and Charles D. Blanke,
M.D., of Oregon Health & Science University, the SWOG group chair.
Cancer Institute (NCI leads the USA’s National Cancer Program and NIH’s efforts
to dramatically reduce the prevalence of cancer and improve the lives of cancer
patients and their families, through research into prevention and cancer
biology, the development of new interventions, and the training and mentoring
of new researchers.
National Institutes of Health (NIH), the USA’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services.
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