A lot of people think the past predicts the future. I guess if you don’t have anything better, then there’s some truth to that. Recently I got a solicitation from Quintiles telling me just how valuable their database of past history is. You’ve probably heard the same promises – we know which sites produce, what kind of design works, and so forth. Trouble is, a lot of once-promising companies learned the hard way that basing present strategy and current trial management on the past is pretty risky. And it’s a risk that you don’t have to take.
The trouble with planning the next trial based on experience is that this amounts to an educated guess. But our guesses are frequently wrong – it’s just a question of how much and in what direction. If you have made spot-on estimates of the delta—the difference in effect between your drug and the comparator—then you can count your lucky stars. But you can’t count on the stars to ensure the success of your next trial any more than you can count on a database that represents the past. Otherwise, we would do horoscopes for new drugs instead of conducting clinical trials. Neither history nor horoscopes will do the trick.
Personally, I think Peter Drucker knew more about predicting the future than Quintiles does (or any of the other CROs using the same message). Drucker put it this way: “The best way to predict the future is to create it.”
I would say the best way to predict the future of your next clinical trial is to create it by managing it effectively. And that requires having the timely information you need to make frequent, almost continuous changes during the study in operational elements like monitoring and enrollment, whether it’s to the frequency of site visits, the messaging that brings patients to the door, advertising methods, how disseminated, or anything else. Timely information collected during trials also enables you to make more targeted adjustments in design parameters such as sample size.
Sorry, Quintiles. Instead of the lazy way of looking backward, why not improve your service and give your clients what’s important to their success—the ability to track performance and continuously refine trials by making earlier, better decisions? That’s the way to finish trials faster, whether by terminating a futile effort or minimizing time to market.
For sponsors, the choice is between mimicking the past and controlling your future. Which approach would you prefer?