Always the seen vs the unseen. Seen: this is what we did. Unseen this is how we made things worse- ethically, theoretically and MOST importantly? For best patient outcomes in science. Such a well written piece. Thank you for taking the time to write and publish.
This issue of having control arms that do not represent the standard of care is not simply an issue related to this particular metastatic prostate cancer trial. Unfortunately, it is common to industry-funded trials for many malignancies (and usually those that have been farmed off to 3rd world countries such as India), especially hematological ones, as our friend Vinay Prassad would point out time and time again on one of his podcasts.
The ARANOTE trial should never have been approved by the IRB and should never have been published by the journal, and the authors of the trial should have been investigated for unethical medical behavior.
I agree, their argument doesn’t hold up well when using cost and resource limitation as justification. There was a formal JCO critique about “inferior control arms,” and a published reply from ARANOTE investigators defending the control as acceptable for participating regions and patients. At least there was transparency on the rationale and I’m not sure I would go as far to say the study was unethical.
Of course it was unethical, and more importantly the results of the trial are irrelevant to the US or any other 1st world country. The control arm in cancer trials should always be no less than the standard of care in the US – not the standard of care on some 3rd world country.
Always the seen vs the unseen. Seen: this is what we did. Unseen this is how we made things worse- ethically, theoretically and MOST importantly? For best patient outcomes in science. Such a well written piece. Thank you for taking the time to write and publish.
Another sophistic Pharma $cience set-up to suck unseemly amounts from the govt teat
This issue of having control arms that do not represent the standard of care is not simply an issue related to this particular metastatic prostate cancer trial. Unfortunately, it is common to industry-funded trials for many malignancies (and usually those that have been farmed off to 3rd world countries such as India), especially hematological ones, as our friend Vinay Prassad would point out time and time again on one of his podcasts.
The ARANOTE trial should never have been approved by the IRB and should never have been published by the journal, and the authors of the trial should have been investigated for unethical medical behavior.
I agree, their argument doesn’t hold up well when using cost and resource limitation as justification. There was a formal JCO critique about “inferior control arms,” and a published reply from ARANOTE investigators defending the control as acceptable for participating regions and patients. At least there was transparency on the rationale and I’m not sure I would go as far to say the study was unethical.
Of course it was unethical, and more importantly the results of the trial are irrelevant to the US or any other 1st world country. The control arm in cancer trials should always be no less than the standard of care in the US – not the standard of care on some 3rd world country.
Point taken, interested to hear others thoughts as well.