A recently published paper in Limits in Pharmacology addresses the threat to the public from exaggerating the importance of inconclusive studies from both the media and the scientific community. Alternatively, the authors suggest doing more rigorous preclinical research before starting human clinical trials.
“We propose that a more scientifically sound regulatory process will lead to advances in the development of new immunotherapies for cancer,” says Dr. med. Antonio Giordano, founder and director of the Sbarro Institute for Cancer Research and Molecular Medicine at Temple University and co-author of the paper. “There has to be a balance between wanting positive outcomes and the need for quality and validation of new drugs for cancer immunotherapy. Resources devoted to trials of drugs with weak preclinical findings are of very little use to patients and should better be spent on preclinical trials to identify therapies with greater potential. “
The authors also express concern that current trends a de facto Ending up in independent clinical research because of the high costs and conditions favored by only a handful of large pharmaceutical companies. Citing 45 other sources, the paper describes the barriers to advancement in immunotherapy and provides an alternative foundation for the future of preclinical and clinical research in this area.
“There is a gap between preclinical and clinical research that can be closed by independent studies,” explains Dr. Luciano Mutti, professor at the Sbarro Institute and co-author of the work. “We see too many clinical trials, many of them on immunotherapy, that appear to be looking for new indications for an existing drug rather than basing drug development on solid science.”
The paper also cites studies on the failure of many drug trials to meet critical design standards.
“Many studies are severely affected by the lack of a suitable control arm,” says Mutti, “and the studies are too fragile and lose their meaning if only one patient in hundreds is moved from one arm to the other. Often there is no explanation as to why patients are excluded from the study and we do not know whether retention would affect the outcome. In 2019 alone, 15 cancer drugs were approved without a study comparing their effects with a control. “
Edited by Gary Cramer