A recently published paper in Frontiers in Pharmacology addresses the threat posed to the public by overstatements of the significance of inconclusive studies from both the media and the scientific community itself. Alternatively, the authors propose an emphasis on more rigorous preclinical research before in-human clinical trials are launched.
“We propose that a more science-based approval process will lead to progress in developing new immunotherapies for cancer,” says Antonio Giordano, MD, PhD, founder and director of the Sbarro Institute for Cancer Research and Molecular Medicine at Temple University and coauthor on the paper. “There must be balance between the desire for positive results and the need for quality and validation of new drugs for cancer immunotherapy. Resources devoted to trials testing drugs with weak preclinical evidence end up to be of very little benefit to patients, and would be better spent on preclinical studies to identify therapies with greater potential.”
The authors also raise concerns that the current trends have created a de facto muzzle on independent clinical research, due to high costs and conditions that favor only a handful of large pharmaceutical companies. Citing 45 other sources, the paper details the impediments to progress in immunotherapy, and lays out an alternative groundwork for the future of preclinical and clinical research in this field.
“There is a gap between preclinical and clinical research which can be filled by independent studies,” explains Luciano Mutti, PhD, a professor at the Sbarro Institute and coauthor of the paper. “We see too many clinical trials, many of them on immunotherapy, which seem to be in search of new indications for an existing drug for profit, rather than basing drug development on a solid scientific background.”
The paper also cites studies into the failure of many drug trials to meet critical design standards.
“Many trials are heavily affected by the lack of a proper control arm,” Mutti says, “and the studies are too fragile, and lose their significance when just a single patient out of hundreds is moved from one arm to another. Often there is no explanation of why patients are dropped from the study, and we do not know if keeping them in would affect the outcome. In 2019 alone, 15 cancer drugs have been approved without a study comparing their effects with a control.”
Edited by Gary Cramer