Let’s talk about how to deal with trials that go away unexpectedly. I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Any of us who’ve been in the industry for any length of time know that trials go away unexpectedly, sometimes while the trial is running.
Examples of that could be when there’s an interim data analysis and the predetermined statistical analysis said that there was futility met or conversely enough data that proves that that it’s statistically significant meeting their endpoint, and you thought you had much more time to enroll or much more future revenue coming in from that trial, and then the trial stops unexpectedly.
Another example is when trials that are ramping up to stars all of a sudden go away, and it happens all the time. It happens more often than we would want, certainly more often than we many times predict. There are times where the trial is delayed because maybe FDA mandated a change to the protocol or a new guidance document was released by FDA. There are times when the trial is delayed because many times trials are overlapping in parallel with one another. And so, a data analysis of a prior trial, whether it’s a sister study or a prior phase, may all of a sudden be showing some change in the data. And so therefore, the sponsor delays launching the trial that you were gonna do while they complete the data analysis because they may want to revise the protocol based upon some new information.
And sometimes, the trial just goes away. Sometimes the trial is a global trial and it enrolled so well in Europe that they decided to never open your country. And you’ve already done contract and budget regulatory, your staff is trained, they’ve been waiting for this trial. You adjusted staff roles and responsibilities around your analysis of their capacity. So that you had available capacity on your team to do this trial, maybe you even hired to do this trial and it just simply goes away. And now not only has your revenue gonna gone down, but you lost quite a bit of profitability because you had dedicated so much to this trial.
It’s relatively unpredictable which trials are going to go away, but it’s massively impactful to the site and what you got compensated for startup expenses will never make you whole when a trial goes away. If you were successful in negotiating an early termination fee, it will be minuscule and will be meaningless in the overall scheme of things when it comes to your lost revenue, your lost profit, and, and the impact to what you did to other trials to adjust capacity to be able to do this trial for this given sponsor.
It is the nature of our space. It’s the nature of this industry. When it happens, it’s not your fault but you do need to run your company in a way that you are adjusting for it as best you can. So, a couple of tidbits I would leave you:
One, be conservative in your hiring. I’ve been burned more times than I would like to admit when I’m staffing up for a trial that then never happens. You’re staffing up for growth for a blockbuster couple of months of enrollment, for example, in a trial that never happens.
Two, in your forecasting. I would highly recommend that you discount future revenues in your blockbuster trials. So, when you’re forecasting, when you are budgeting for the future, you’re doing so based upon what you know or you think, you know. I would suggest that when a tiny trial goes away, it doesn’t have a massive impact on your budget and therefore it doesn’t have a massive impact on making payroll, et cetera. But when you’ve got a blockbuster trial, if it goes away, it has a massive impact. I would recommend you discount your blockbuster trials more heavily to account for the fact that it is going to happen. And then frankly, the larger you become, the more often you will experience it just because you’re larger, you have more trials and so, let’s make up numbers. Let’s say 1 trial out of every 50 actually disappears, actually just never starts, just goes away. Well, if you’ve got 50 trials a year, you experience that once a year. If you’ve got 500 trials a year, you’re going to experience that 10 times a year. It has a more expansive impact the larger you get, and you’ll simply experience it more. So, my recommendations fuel for thought. It’s painful. It always will be. I don’t think there’s an actual fix but be conservative and alter your future forecasting because it will happen. As always, thank you for riding along. Keep doing good work. Take care.