Thank you. As a fellow oncologist, I once received an "honorarium" to participate in a discussion where the group leader reviewed the ADAURA trial. I raised similar questions about the survival analysis and the potential lack of availability of osimertinib in post-progression care. I haven't been invited back. (shrug)
I think it is worth point out that osimertinib is an unassailable and highly effective drug for metastatic EGFR-mutated lung cancer where surgery is not an option. This article is asking a more subtle, but still important question about its utility in earlier stage disease that has already been surgically removed.
The only part about this which does not stink to high heaven, is that the “standard of care” (to which the control arm should always be availed) will often evolve during the course of a trial. That’s not the fault of investigators or sponsors. However, what IS needed, as the author notes, is a clear mechanism to augment the protocol during the study, such that optimal control arm care is provided throughout the study. It is a pathetic excuse to claim some countries can’t provide such care…if that’s the case, don’t include those patients from those countries in the final primary endpoint analysis.
But otherwise, is nobody giving a darn about ICH-GCP research standards? Do these researchers and sponsors not give a hot darn about the wellbeing of the subjects? (You don’t need to answer that, as I wasn’t born yesterday).
I agree with the main point. Regulators have absconded on their fiduciary duty. Companies will clear the regulatory bar that is set for them, and not go 1 micron higher. To believe otherwise is to ignore the entirety of human nature. So it is up to regulators to hold a firm line, and reject studies and applications where the up-to-date standard of care was not provided to control arm patients throughout a study.
Yeah; surprising. Almost as if sponsors could care less about the individual patients, so long as the trial churns out the desired outcome.
After more than three decades in oncology, my distaste for many oncology trials, including those that authoritatively declare PFS to be sufficient proof of benefit (often measured in WEEKS), I’m not shocked. Like seeing your next door neighbor, the professional escort walk out of a different apartment building every few mornings, one comes to expect it.
Great post. Thanks for your time. Anyone wanting additional information on similar topics should read the book malignancy.
100% agree with your book recommendation : https://www.amazon.fr/Malignant-Policy-Evidence-People-Cancer/dp/1421437635
Thank you. As a fellow oncologist, I once received an "honorarium" to participate in a discussion where the group leader reviewed the ADAURA trial. I raised similar questions about the survival analysis and the potential lack of availability of osimertinib in post-progression care. I haven't been invited back. (shrug)
I think it is worth point out that osimertinib is an unassailable and highly effective drug for metastatic EGFR-mutated lung cancer where surgery is not an option. This article is asking a more subtle, but still important question about its utility in earlier stage disease that has already been surgically removed.
The only part about this which does not stink to high heaven, is that the “standard of care” (to which the control arm should always be availed) will often evolve during the course of a trial. That’s not the fault of investigators or sponsors. However, what IS needed, as the author notes, is a clear mechanism to augment the protocol during the study, such that optimal control arm care is provided throughout the study. It is a pathetic excuse to claim some countries can’t provide such care…if that’s the case, don’t include those patients from those countries in the final primary endpoint analysis.
But otherwise, is nobody giving a darn about ICH-GCP research standards? Do these researchers and sponsors not give a hot darn about the wellbeing of the subjects? (You don’t need to answer that, as I wasn’t born yesterday).
I agree with the main point. Regulators have absconded on their fiduciary duty. Companies will clear the regulatory bar that is set for them, and not go 1 micron higher. To believe otherwise is to ignore the entirety of human nature. So it is up to regulators to hold a firm line, and reject studies and applications where the up-to-date standard of care was not provided to control arm patients throughout a study.
I always wonder why REBs approve some of these studies. Well as I was also not born yesterday I can guess.
Yeah; surprising. Almost as if sponsors could care less about the individual patients, so long as the trial churns out the desired outcome.
After more than three decades in oncology, my distaste for many oncology trials, including those that authoritatively declare PFS to be sufficient proof of benefit (often measured in WEEKS), I’m not shocked. Like seeing your next door neighbor, the professional escort walk out of a different apartment building every few mornings, one comes to expect it.
Great article! Thanks
Thank you !