Newswise – A paper recently published in Frontiers Medicine, entitled “Is there a need for re-registration of cancer immunotherapy already?” addressing the threat by over-emphasizing inaccurate studies of the public by the media and by the scientific community itself.
On the other hand, the authors recommend emphasizing a more rigorous, preclinical, specific study before testing new therapies in clinical settings.
“We propose that a science-based approval process will further advance the development of new immunotherapies for cancer,” said 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 paper. “There has to be a balance between the desire for positive results, and the need for quality and proven new drugs for cancer immunotherapy,” Giordano says. “There will be little benefit to facilities testing drugs with weak preclinical evidence, and it would be better to spend on preclinical studies to identify treatments with greater potential.”
“The last decade of study of the genetics and molecular biology of cancer has provided an unprecedented understanding of the causes, onset, and progression of human tumors,” says Luciano Mutti, Ph.D., Professor at the Institute Sbarro and co-author of the paper. “Now is the time to take advantage of this wealth of knowledge, but there seem to be major hurdles.”
The authors also raise concerns that current trends have created a de facto cluster of independent clinical study, due to high costs and conditions that favor just a handful of pharmaceutical companies. large. Citing 45 other sources, the paper outlines the barriers to progress in immunotherapy, and outlines another basis for future preclinical and clinical study in this area.
“There is a gap between preclinical and clinical study that can be filled by independent studies,” explained Mutti. “We are seeing too many clinical trials, many of them on immunotherapy, that seem to be finding new indications for a drug that is for profit, rather than basing drug development on a strong scientific background. . ”
The paper also cites studies on the failure of many drug tests to meet required design standards.
“The lack of a proper control arm greatly affects many tests,” Mutti says, “and the studies are too fragile, and lose their importance when only one in hundreds of patients is moved from one to the other. arm to another. There is often no explanation for why patients are excluded from the study, and we do not know whether inclusion would affect the outcome. In 2019 alone, 15 cancer drugs were approved without a study comparing their effects with control, ”Mutti concludes.
“Mesothelioma is a clear example of drug testing that is not only poorly supported by preclinical science, but which even contradicts the evidence,” Giordano said. “An independent organization we work with has just audited all tests, including immunotherapy, for Mesothelioma since 2003. The emerging situation is difficult to us and will be published shortly to raise awareness of the need to change direction. It should represent a caveat for future studies, ”Giordano concludes.
About Sbarro Health Check Group (SHRO)
Sbarro Health Research Group is a non-profit charity committed to funding excellence in basic genetic research to treat cancer, cardiovascular disease, diabetes and related debilitating diseases and to train encourage young doctors in a spirit of professionalism and humanity (www .shro.org)