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Clinical development success rates and social value of pediatric Phase 1 trials in oncology
A team of researchers led by bioethicist dr hab. Marcin Waligóra, professor of the Jagiellonian University, conducted an analysis in which they measured the indicators of the social value of Phase 1 clinical trials in oncology, which are not passed to the next phases.
One of the indicators of social value is the success of the study in approving the tested drug for use. Usually the drug must pass 3 phases of clinical trials before being approved.
As it turns out, after the completion of all the phases, just about 5% of the drugs tested in the Phase 1 in pediatric oncology reach the market. But is the final selection of the drug that will be put to use the only value of Phase 1 clinical trials?
Phase 1 trials, in addition to clarifying whether a drug is suitable for the transition to the next phases of clinical trials, also allows to determine which drugs are not suitable for it. It provides other researchers with a valuable information on which direction not to follow.
The research team led by professor Waligóra put emphasis on the ethical aspects of Phase 1 clinical trials, especially in the case of oncological drug trials involving pediatric patients. It is essential that patients and their caregivers are informed that the chance of obtaining a therapeutic effect through participation in an early-stage clinical trial is unfortunately very low. The knowledge gained from conducting such research will benefit patients in the future, but not necessarily the participants of the trials themselves. Consequently, participants are often motivated by altruistic motives. Clear information about the nature of Phase 1 trials in pediatric oncology will allow to maintain a high level of trust in medicine and science.
Link to the publication:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0234911
The publication was funded by the qLIFE Priority Research Area as part of the Strategic Programme Excellence Initiative at the Jagiellonian University.
Information on the qLife PRA’s homepage:
https://qlife.cm-uj.krakow.pl/aktualnosci/marcinwaligoraartykul/
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