Cancer experts demand that clinical trials be reformed, with a focus on independent studies.

Cancer experts demand that clinical trials be reformed, with a focus on independent studies.

“Is There Already a Need for a Reckoning on Cancer Immunotherapy?” asks a recent study published in Frontiers Pharmacology. The harm presented to the public by the media and the scientific community overstating the relevance of inconclusive findings is addressed. Instead, the authors recommend focusing on more robust, preclinical, and specialized research before putting new medicines to the test in clinical settings.

“We propose that a more science-based approval process will lead to progress in developing new cancer immunotherapies,” says Antonio Giordano, M.D., Ph.D., co-author on the paper and founder and director of the Sbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple University. “There must be a balance between the desire for favourable results and the necessity for new cancer immunotherapy medicines to be of high quality and validated,” Giordano adds.

“Research into the genetics and molecular biology of cancer over the last 10 years has allowed for unparalleled knowledge of the origins, genesis, and course of human tumours,” says Luciano Mutti, Ph.D., Sbarro Institute Professor and co-author of the article. “It is now time to properly use this information wealth, yet there appear to be substantial roadblocks.” The authors also express worries that present trends have effectively stifled independent clinical research because of high costs and conditions that benefit a small number of major pharmaceutical corporations. The article highlights the barriers to development in immunotherapy and puts forth an alternate basis for preclinical and clinical research in this subject, citing 45 other sources.

“There is a vacuum between preclinical and clinical research that independent studies can fill,” Mutti adds. “We see far too many clinical studies, many of them on immunotherapy, that appear to be looking for new indications for an existing medicine in order to make a profit, rather than developing drugs based on good scientific evidence.”

Many drug trials fail to fulfil essential design requirements, according to research included in the study.

“Many trials are harmed by the lack of a good control arm,” Mutti adds, “and the studies are too fragile, and their relevance is lost when only one patient out of hundreds is transferred from one arm to another.” Patients are frequently dropped from studies without reason, and we don't know if keeping them in would alter the outcome. In 2019, 15 cancer medicines were authorised without a research comparing their effects to a control, according to Mutti.

“Mesothelioma is a clear example of evaluating medicines that are not only unsupported by preclinical science, but also contradict evidence,” Giordano says. “An independent organisation with which we are collaborating just completed a review of all Mesothelioma studies, including immunotherapy, conducted since 2003. The scenario that emerged astounded us, and it will be publicised soon to raise awareness of the need to alter course. It should serve as a cautionary note for future research,” Giordano concludes.

Dr. Antonio Giordano is the President and Founder of the Sbarro Health Research Organization (SHRO), which conducts research to diagnose, treat and cure cancer, cardiovascular disease, diabetes and other chronic illnesses.