4 ms·

You have basically just summarised what I said :) I would not say the criteria are just “tweaked” between Phase 2 and 3 with any drug aimed at a broad market.

You have basically just summarised what I said :) I would not say the criteria are just “tweaked” between Phase 2 and 3 with any drug aimed at a broad market. It is always a balance between broadness and success and sometimes even the best in the business get it wrong. The FDA do allow a broader label than the exact trial criteria, but not massively so. If you restrict the Phase 3 to an identifiable sub-population good luck getting approval to expand to the larger population without running post-approval trials.

refurb 8y ago
Where we disagree is on three points:(1) marketing gets involved well before phase 3,(2) most trial criteria don’t change that much between phase 2 and 3 [yes there are exceptions] and (3) the FDA allowing a broader label than inclusion criteria. As for the last one, most phase 3 trials have strict criteria: no other diseases, age limits, disease severity limits, etc. Those typically don’t make it into the label’s indication. I do agree that trials are designed to balance getting a positive outcome vs. the broadest population possible, but marketing isn’t the only one driving that.
- danieltillett 8y ago
  1. Yes marketing gets involved before Phase 3, but they tend to not have the clout they have going into Phase 3 - generally when it is unclear that you have something that works at all it hard for marketing to argue in favour of broadening the inclusions criteria. 2. I think your point 2 is where we disagree the most. We are really arguing over what is a significant change or not. 3. The FDA will be looser on some things like age and other diseases (within reason as you won’t get approval for children if you only trial in adults), but not on sub-groups. If you make your trial exclude on some disease sub-group criteria you are not going to get FDA approval to go outside that sub-group and sell to everyone with the disease. Who is driving trial broadening other than marketing? If I want the drug to succeed I want the trial population to be a homogeneous as possible and only include likely responders.

refurb 8y ago

Where we disagree is on three points:(1) marketing gets involved well before phase 3,(2) most trial criteria don’t change that much between phase 2 and 3 [yes there are exceptions] and (3) the FDA allowing a broader label than inclusion criteria. As for the last one, most phase 3 trials have strict criteria: no other diseases, age limits, disease severity limits, etc. Those typically don’t make it into the label’s indication. I do agree that trials are designed to balance getting a positive outcome vs. the broadest population possible, but marketing isn’t the only one driving that.

danieltillett 8y ago
1. Yes marketing gets involved before Phase 3, but they tend to not have the clout they have going into Phase 3 - generally when it is unclear that you have something that works at all it hard for marketing to argue in favour of broadening the inclusions criteria. 2. I think your point 2 is where we disagree the most. We are really arguing over what is a significant change or not. 3. The FDA will be looser on some things like age and other diseases (within reason as you won’t get approval for children if you only trial in adults), but not on sub-groups. If you make your trial exclude on some disease sub-group criteria you are not going to get FDA approval to go outside that sub-group and sell to everyone with the disease. Who is driving trial broadening other than marketing? If I want the drug to succeed I want the trial population to be a homogeneous as possible and only include likely responders.