Every visit to the US reminds me of just how bad DTC advertising is. Not the principle, which is debatable, but the quality.
Let’s unpack…
Just this week, I’ve seen a bunch of ads whose sole pitch is that they are ‘A1C drugs’. This despite most people with diabetes not understanding HbA1C, and probably not measuring it routinely. That is bad enough, but to have them all blur into one as actual ads is shameful - who’s gaining differentiation from this (even the truly great products look like older drugs on this channel)?
Let’s be clear - like many clinical trial metrics, things that are easy to study in the clinic are not real world metrics (they’re hard to use, like PANSS or ADAS-Cog, or work well for a population mean but less well for an individual (OS/PFS…)). So why, apart from agencies having little imagination, do we have a situation like this?
If you work back from the toolbox they have to play with, DTC has to stick to the label. If it wasn’t in your phase III, it won’t be in your label. If you don’t study it, you don’t get to make a claim. That is reasonable, and fair. If you want it to be in your phase III, you’d include it as an outcome in your phase II, so that you’re not going into pIII at risk.
If you think phase III is just for gaining an approval, carry on as you are. If you think your approval is when the hard work of persuading real people in the real world to use your drug starts, then you’d be validating better endpoints (and potential claims) in phase II. That may lead to more numerical ‘failures’ of your studies, but that’s OK (your company incentive structure might argue with that premise).
How do you do more interesting phase IIs? You start the planning in phase I (or earlier), with better hypotheses, better path to market strategy - with positioning. Once you are in phase II, you are already sailing towards your chosen port, endpoints left behind when you left your home. You can pause the ship and turn around, or be stopped by a storm, but your destination is pretty much fixed.
The reason DTC ads suck so much is not (just) the lack of imagination or understanding of positioning in agencies and Commercial. The reason DTC ads suck so much is the lack of imagination and understanding of positioning in R&D.