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alexandrabuga replied to the topic Clinical Studies in the forum Clinical Research Basics 7 years, 5 months ago
I agree with @reshamn and @dag56 that there are many advantages to clinical trials including having patients have access to new treatments. At Sloan there are many clinical trials which include testing new drugs or drug combinations. As many have mentioned the patients understand the risks of entering a clinical trial, but especially in the oncology field, many do no have options and are eager to participate in clinical trials. Immunotherapy is really interesting field with the idea of using yourself to heal yourself. Car-T cell therapy engineers a patient’s immune cells to treat their cancers. Car-T cell clinical trials are very popular and have seen success. For example as the NCI has stated- in ALL-one of these earlier trials, used CD19-targeted CAR T cells, all signs of cancer disappeared in 27 of the 30 patients treated in the study, with many of these patients continuing to show no signs of recurrence long after the treatment.These early successes laid the foundation for a larger trial of a CD19-targeted CAR T-cell therapy, called tisagenlecleucel (Kymriah), for children and adolescents with ALL. Many of the patients who participated in the trial, funded by Novartis, had complete and long-lasting remissions. Based on the clinical trial results, the FDA approved tisagenlecleucel in August 2017. ALL is the most common cancer in children, so this is really a break through. Creating treatments to provide patients with options where there haven’t been is really remarkable. However, all clinical trials have risks and there are side effects and the potential of not making it trough. For example in two Juno trials, the FDA had to stop a study after three patients died of cerebral edema. As article in stat news ” Juno maintained that the problem was not with its product — an infusion of genetically engineered cells — but rather with a cocktail of chemotherapies used to treat patients before they got the experimental therapy. The company removed one of those chemo drugs, called fludarabine, from the cocktail, and the FDA quickly gave Juno the green light to resume the study.”. Overall, as many have mentioned clinical trials are important to provide patient’s new treatments, but they do come with risks. Since the patients are aware of the risks involved in the clinical trial and voluntarily opt-in to them, I believe that clinical trials are necessary. We learn a lot from clinical trials even if they don’t go as expected.
Two patient deaths halt trial of Juno’s new approach to treating cancer