What Are IDEAs Made Of: Thinking ahead
Here’s a challenge: Imagine loading a container ship setting sail from the US to Europe, and then having to sell the contents for a profit when it lands in Europe.
You would pay a lot of attention to what you put in at the US dock, surely? Maybe you’d have conducted an awful lot of research into what you might be able to sell when you got to the other side, looked for a big idea that those Europeans don’t have yet?
If you put in, for example, a few thousand iPods, took six months to sail them over, and then expected to have your salespeople make a fortune from them once landed, you’d be a little miffed to find that Apple had upgraded the specifications since you set off.
If you knew that you couldn’t change your consignment once at sea, you’d think pretty hard about it before you left… If the shipping list you leave the US with is the shipping list you are taking to Europe, that label should have withstood rather a lot of attention.
If, in addition, you wanted to include on the consignment some clever extra device that would boost sales of your iPod, but before you could set sail, you had to prove its seaworthiness, then that would mean a period of pre-evaluation well before you journeyed to the US docks.
However, every week, phase III trials are setting sail loaded with comparators that aren’t Standard of Care. Studies are beginning without diagnostics, PROs, or even the correct dose, because they weren’t validated in pIIb. (And, if they are going to be validated in pIIb, they need to have been thought about a little bit earlier…)
If you thought that there may be a problem for your consignment in customs, you’d also make sure that the necessary paperwork accompanied the contents. However, drugs are still failing in registration or in market access.
What goes into pIII is what comes out of pIII. The idea of your drug is what you study in pIII. By the time your pIII clinical plan is locked, you have no opportunity to alter what you’re taking to market – it’s a done deal, if you didn’t get it right before setting sail, it will never be right. You can alter what you say about it, but you have what you have.
“What goes into pIII is what comes out of pIII. The idea of your drug is what you study in pIII. By the time your pIII clinical plan is locked, you have no opportunity to alter what you’re taking to market – it’s a done deal”
(And, given that phase III clinical trial plans tend to get locked six months ahead, anything that suggests a mistake is being made during that six months is an awfully inconvenient truth. Just try it – see how the development group like it when you point out something else you’d like in the pIII just as they’re about to set out…)
Unfortunately, the problem is not that the ships are not making it to shore – this piece isn’t about pIII attrition (or ships sinking at sea…). More and more often, ‘marketers’ are being given faits accompli (French for ‘whatever Clinical wanted to do…’), and increasingly aren’t even allowed to message what is not in the label (which brings us right back to the earlier point…).
That basic truth might give most a pause for thought: decisive hesitation beats hesitant decision, right? Well, I suspect that you can name three or four drugs instantly that could have done a better phase III, and done so predictably (without the benefit of hindsight, just a little foresight…). Why is that? Thinking is relatively cheap, certainly cheaper than beginning a study that proves next to nothing. However, the industry still sees phase III as something special, a time to start investing in ‘marketing’, rather than as a rather predictable journey between the beginning of the study and the end.
Ideas should be generated in phase II, and the idea that you want to take to market studied in phase III, not bolted on as an afterthought at the other end.
About the author:
Mike Rea is a Principal with IDEA Pharma, who enjoys taking a look outside the industry to learn how it can think differently. For direct enquiries he can be contacted on email@example.com and for more information on IDEA Pharma please see http://www.ideapharma.com/what/default.htm.
The next WAIMO piece will be in a couple of weeks.
How can better forward planning be integrated into drug development?