Cancer Experts Call for Reform of Clinical Trials, with an Emphasis on Independent Studies

A recently published paper in Frontiers Pharmacology, titled “Is There Already Need of a Reckoning on Cancer Immunotherapy?” addresses the threat posed by overstating the significance of inconclusive studies to the public by both the media and the scientific community itself. 

Alternatively, the authors propose an emphasis on more solid, preclinical, specific research before testing new therapies in clinical settings. 

“We propose that a more science-based approval process will lead to progress in developing new immunotherapies for cancer,” says Antonio Giordano, M.D., 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 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,” Giordano says. “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 last ten years of research into the genetics and molecular biology of cancer have allowed for unprecedented understanding of the causes, onset, and progression of human tumours,” says Luciano Mutti, Ph.D., Professor at the Sbarro Institute and co-author of the paper. “It is now time to fully exploit this treasure of knowledge, but it seems there are significant hurdles.”

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 Mutti. “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,” Mutti concludes.           

“Mesothelioma is a clear example of testing drugs that are not only poorly supported by preclinical science, but that even go against the evidence,” adds Giordano. “An independent group we are working with has  just completed an analysis of all the trials, including immunotherapy, for Mesothelioma since 2003. The scenario coming out dismayed us and  will be published soon to increase awareness on the need to change direction. It should represent a caveat for future studies,” Giordano concludes.

 

About the Sbarro Health Research Organization (SHRO)

The Sbarro Health Research Organization is a non-profit charity committed to funding excellence in basic genetic research to cure and diagnose cancer, cardiovascular diseases, diabetes and related chronic illnesses and to foster the training of young doctors in a spirit of professionalism and humanism (www.shro.org)