The best we can do at present is compare between arms to see if differences in post-protocol treatment may account for differences in OS.
While agreeing this is a problem in interpretability of oncology trials, I don't foresee a landscape in which sponsors agree to dictate (and fund) post-protocol therapy, in which ECs will wave such protocols through, or oncologists accept sponsors making their treatment determinations for them.
Equally, the suboptimal treatment in countries less well-off than the USA or Switzerland is real-world. A different regimen or order of regimens may work fine where you have essentially unlimited cash to pay for therapies of marginal OS benefit, but something different in places where this is not the case. Cancer patients, and their physicians, in those places, also deserve to know what is the best option within their real-world limitations.
This is interesting work but there are bigger problems with recent FDA approvals, delinquent control groups, single-arm trials, non-robust endpoints, essentially a big recent departure from the need to demonstrate OS benefit in at least one, and optimally 2, well-controlled trials.
This is an incredibly insightful and thought-provoking piece on the importance of treatment after progression in oncology studies. The three scenarios you've outlined clearly illustrate the potential pitfalls and biases that can occur in clinical trials, particularly when they are conducted globally and include countries with varying levels of access to optimal care.
The issue of substandard post-protocol therapy, as highlighted in the LATITUDE trial, is particularly concerning. It's disheartening to think that trials aiming for market dominance in wealthier nations may inadvertently lead to biased survival results due to the lack of access to superior treatments in lower-income countries once the trial has concluded.
Your comprehensive assessment of trials published in top journals and those leading to FDA approval further underscores the gravity of this issue. The fact that only a small percentage of these trials had appropriate post-progression data is indeed alarming.
The '10 percent rules' you propose seem like a practical and effective way to ensure optimal post-progression treatment in both test and control groups. It's a step in the right direction towards improving the reliability of clinical trial results and ultimately, patient outcomes.
Thank you for shedding light on this critical aspect of oncology studies. Your research is a valuable contribution to the field and I look forward to seeing how it influences future trials and regulatory decisions.
The best we can do at present is compare between arms to see if differences in post-protocol treatment may account for differences in OS.
While agreeing this is a problem in interpretability of oncology trials, I don't foresee a landscape in which sponsors agree to dictate (and fund) post-protocol therapy, in which ECs will wave such protocols through, or oncologists accept sponsors making their treatment determinations for them.
Equally, the suboptimal treatment in countries less well-off than the USA or Switzerland is real-world. A different regimen or order of regimens may work fine where you have essentially unlimited cash to pay for therapies of marginal OS benefit, but something different in places where this is not the case. Cancer patients, and their physicians, in those places, also deserve to know what is the best option within their real-world limitations.
This is interesting work but there are bigger problems with recent FDA approvals, delinquent control groups, single-arm trials, non-robust endpoints, essentially a big recent departure from the need to demonstrate OS benefit in at least one, and optimally 2, well-controlled trials.
Good stuff -May be this would explain why ribociclib is the only CDK4/6 with an OS benefit...
This is an incredibly insightful and thought-provoking piece on the importance of treatment after progression in oncology studies. The three scenarios you've outlined clearly illustrate the potential pitfalls and biases that can occur in clinical trials, particularly when they are conducted globally and include countries with varying levels of access to optimal care.
The issue of substandard post-protocol therapy, as highlighted in the LATITUDE trial, is particularly concerning. It's disheartening to think that trials aiming for market dominance in wealthier nations may inadvertently lead to biased survival results due to the lack of access to superior treatments in lower-income countries once the trial has concluded.
Your comprehensive assessment of trials published in top journals and those leading to FDA approval further underscores the gravity of this issue. The fact that only a small percentage of these trials had appropriate post-progression data is indeed alarming.
The '10 percent rules' you propose seem like a practical and effective way to ensure optimal post-progression treatment in both test and control groups. It's a step in the right direction towards improving the reliability of clinical trial results and ultimately, patient outcomes.
Thank you for shedding light on this critical aspect of oncology studies. Your research is a valuable contribution to the field and I look forward to seeing how it influences future trials and regulatory decisions.