CAR-T ICU 2019 | Increase in cancer patient transfers to the ICU: what does it come down to?
In this video, Michael von Bergwelt, MD, LMU Hospital Munich, Munich, Germany, discusses the factors behind the increasing numbers of cancer patient admissions to the intensive care unit (ICU). This interview took place at the CAR-T Cell Therapy and the ICU meeting in London, UK, which was organized by EuroCARTForce.
Transcript (edited for clarity)
yeah so we are in times where we cannot rely on the big trial data for evidence generation anymore because we have a lot of subgroups patient subgroups diagnostic subgroups so the the groups we are treating are getting much smaller and smaller and that’s why we have to think about novel ways of getting trials up and running so the regular way to create evidence of course is doing a
randomized phase 3 trials with a few hundred patients sometimes a thousand patients as it is in correlation trials for instance and that’s not going [inaudible] work in the future anymore at least for patients who had a relapse or patients with high-risk disease and rare diseases so what’s been done in recent years is then the basket trials where let’s say you have one drug and you test this drug in
several indications who all have for instance mutations in a certain pathway where this drug is active and now in personalized medicine we are fighting with the opposite problem we have one patient but we have diagnostic tools to let’s say open up 50 different treatment possibilities for this patient personalized treatment so how are you going to put this in in a clinical trial and that’s a challenge for
the agencies like email that’s a challenge for the ethics committee and that’s also a challenge of course for us who are planning clinical trials and that’s quite an interesting question from regulatory and clinical point of view and also from the point of view of the patients who are also involved in this type of action how can we and these trials
yeah so we are in times where we cannot rely on the big trial data for evidence generation anymore because we have a lot of subgroups patient subgroups diagnostic subgroups so the the groups we are treating are getting much smaller and smaller and that’s why we have to think about novel ways of getting trials up and running so the regular way to create evidence of course is doing a
randomized phase 3 trials with a few hundred patients sometimes a thousand patients as it is in correlation trials for instance and that’s not going [inaudible] work in the future anymore at least for patients who had a relapse or patients with high-risk disease and rare diseases so what’s been done in recent years is then the basket trials where let’s say you have one drug and you test this drug in
several indications who all have for instance mutations in a certain pathway where this drug is active and now in personalized medicine we are fighting with the opposite problem we have one patient but we have diagnostic tools to let’s say open up 50 different treatment possibilities for this patient personalized treatment so how are you going to put this in in a clinical trial and that’s a challenge for
the agencies like email that’s a challenge for the ethics committee and that’s also a challenge of course for us who are planning clinical trials and that’s quite an interesting question from regulatory and clinical point of view and also from the point of view of the patients who are also involved in this type of action how can we and these trials
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