Have you ever put off talking to your significant other about expensive-but-necessary home repairs, for fear they’ll hit the (leaking) roof? Most of us have, and if we haven’t, we’ve put off some similar difficult conversation.
When the conversation involves a faltering clinical trial, the urge to avoid conflict becomes stronger still. But the longer you avoid that difficult conversation, the greater the risk your trial progresses from faltering to failure. And the deeper a trial’s problems, the more likely you’ll have to ask for a substantial budget increase—another difficult conversation.
Our research shows at least 33% of trials are at risk of failure. Some of that risk is attributable to refusing to undertake corrective action or not communicating that a trial is in jeopardy. Many of these trials fail to complete, but yours doesn’t have to.
Early intervention, whether through an outside rescue or an internal reshuffle, is cheaper, faster, and has a much higher probability of success than waiting until the bitter end. Early intervention is even more critical when you consider the return—not return on investment, but return on intervention.
In our rescue white paper, 3 Measures to Overcome Operational Failures, we explain our ROI concept. Early in a trial, intervention provides dramatic benefits for minimal cost. An assessment or review may be all that’s needed to get a study back on track. Later, ROI decreases because it requires more involvement, such as adding sites or modifying protocols. Just like in sales, you want a high ROI.
Presenting Your Case for Early Intervention
When you have that difficult conversation with your boss, board, or investors about a faltering clinical trial, emphasize the need to act quickly for the best ROI. Executives and investors understand numbers. You can make a strong case for early intervention based on financial benefits alone.
To present your case for a trial rescue, incorporate the following into a presentation:
- Enrollment graphs
- Site activation figures
- Logistics diagrams
- Regulatory reports
- An action plan to move forward
Statistics and a proactive plan make a stronger case than pointing out past mistakes.
Words of Encouragement
Remember, just because a trial stumbles doesn’t mean it will fall. Our research shows that even though 33% of currently active clinical trials are faltering, most of them probably won’t fail outright—at least not at a rate significantly higher than for all trials.
These faltering trials will likely still hit or miss their final endpoints, albeit at a much greater cost and on a significantly longer timeline. The trials that fail to complete often suffer because of budget and time overruns or poor-quality data. In other words, if your trial is scientifically sound, the only way it would fail is if you run out of money or the sponsor pulls the plug.
When you consider the odds of success, sponsors will receive a greater benefit with an intervention than without. The costs associated with soldiering on with a faltering trial far exceed the cost of a rescue.
Even more importantly, early intervention creates a massive risk reduction—risk of bad data, of missing filing deadlines or first-to-file status, of running out of money, and risk of a canceled program. Your financially minded boss, board, or investors should easily see the benefits of providing this level of risk reduction. Plus, because of your hard work and proactive thinking, the sponsor will have a product to market rather than millions of wasted dollars.
If you think your study needs a boost, consider a free study health assessment from Biorasi. In about a week, and with minimum commitment, we’ll put together almost everything you need to successfully make your case for a trial rescue. However you decide to save your trial, don’t procrastinate. Early intervention and transparency go a long way toward putting a lagging trial back on track.