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Newswise – An article recently published in Frontier pharmacology, titled “Should we already evaluate cancer immunotherapy?” addresses the threat posed by overestimating the importance of inconclusive studies to the public by both the media and the scientific community itself.
Alternatively, the authors propose to focus on more solid, preclinical and specific research before testing new therapies in clinical settings.
“We propose that a more scientific approval process will lead to advancements in the development of new cancer immunotherapies,” says Antonio Giordano, MD, Ph.D., founder and director of the Sbarro Institute for Cancer Research and Molecular Medicine , Center for Biotechnology, College of Science and Technology, Temple University and co-author of the article. “There has to be a balance between the desire for positive results and the need for quality and validation of new drugs for cancer immunotherapy,” says Giordano. “Resources spent on trials testing drugs with weak preclinical evidence end up being of little benefit to patients, and would be better spent in preclinical studies to identify therapies with greater potential.
“The last ten years of research into the genetics and molecular biology of cancer have provided unprecedented understanding of the causes, appearance and progression of human tumors,” says Luciano Mutti, Ph.D., professor at the ‘Institut Sbarro and co-author of the article. “Now is the time to fully harness this wealth of knowledge, but there appear to be significant obstacles.”
The authors are also concerned that current trends have created a de facto muzzle on independent clinical research, due to high costs and conditions that only favor a handful of large pharmaceutical companies. Citing 45 other sources, the article details the obstacles to progress in immunotherapy and presents an alternative basis for the future of preclinical and clinical research in this area.
“There is a gap between preclinical and clinical research that can be bridged by independent studies,” says Mutti. “We are seeing too many clinical trials, many of them in immunotherapy, that appear to be looking for new indications for an existing drug for profit, rather than basing drug development on a solid scientific basis.”
The paper also cites studies on the failure of many drug trials to meet critical design standards.
“Many trials are strongly affected by the lack of an appropriate control arm,” says Mutti, “and the studies are too fragile and lose their importance when only one patient in hundreds is moved from arm to arm. ‘other. Often there is no explanation as to why patients are excluded from the study, and we do not know if keeping them would affect the outcome. In 2019 alone, 15 anti-cancer drugs were approved without a study comparing their effects to a control, ”concludes Mutti.
“Mesothelioma is a clear example of drug testing that is not only poorly supported by preclinical science, but even goes against the evidence,” Giordano adds. “An independent group we are working with has just completed a review of all trials, including immunotherapy, for mesothelioma since 2003. The scenario that came out of it shocked us and will be released shortly to raise awareness of the need for change. of management. This should be a warning for future studies, ”concludes Giordano.
About the Sbarro Health Research Organization (SHRO)
The Sbarro Health Research Organization is a non-profit, charitable organization committed to funding excellence in basic genetic research to cure and diagnose cancer, cardiovascular disease, diabetes and associated chronic diseases and to promote the training of young doctors in a spirit of professionalism and humanism (www .shro.org)
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