PLOS Medicine featured an article presenting the results of research conducted by a team led by Dr hab. Marcin Waligóra from the Jagiellonian University Medical College and Prof. Jonathan Kimmelman from McGill University. The paper analyses risk and benefit for phase I clinical trials in pediatric oncology.
In early 2017 Dr hab. Marcin Waligóra from the Department of Philosophy and Bioethics of the JU MC Institute of Nursing and Obstetrics received grant from the J. William Fulbright Foreign Scholarship to continue his research at Harvard Medical School in Boston. The study, which is part of the project “Children in phase 1 cancer trials. Risk and social benefit” started in September 2017 and will continue until May 2018.
In the article entitled ”Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis” Waligóra and Kimmelman’s team estimated the number of side effects (risk) and the organism’s responses to the tested medication (benefit) in phase I clinical trials in pediatric oncology. The systematic review with a meta-analysis studied data from 170 phase I clinical tests carried out on 4,604 oncology patients.
“It’s curious that in spite of the regulation and special design of clinical research, the direct benefit and risk linked to children’s participation in phase I trials in oncology are the same as in case of adults”, says Dr hab. Waligóra. “What also surprises us is the fact that modern personalised therapies have the number of side effects and responses to treatment similar to traditional chemotherapy“, the researcher adds.
The research by the team is described in the article ”New study raises questions about early-stage cancer therapies for children”, published on STAT website that belongs to The Boston Globe.
The meta-analysis is the first in a series of studies aimed at estimating different aspects of risk and benefit in pediatric oncology trials.
The research was funded by the National Science Centre and partly carried out at Harvard Medical School in Boston.
