Are You About to Launch a Clinical Trial? Pump Your Brakes.

As the coronavirus continues to spread and dominate the media, we are inundated with advice on what to do: How to boost our immunity, how to conduct business, how to wash our hands. If you are about to launch a clinical trial or initiate additional sites, consider this advice: press pause.

(Unless, of course, you’re launching a coronavirus trial.)

We understand that you are under a great deal of pressure. There are millions of dollars at stake. Scores of people have been mobilized. Senior management is watching. Investors are anxiously waiting. The stakes are extraordinarily high. All the more reason to seriously consider a purposeful delay.

There’s significant risk involved in clinical trials in the best of times, and today we are far afield from the best of times. Not only are we in the midst of a pandemic, but the effects of that pandemic are still unfolding. It’s clear the virus is spreading, but where, when, and who will be most impacted remains clouded in uncertainty.

What we do know is that work and life are already being disrupted: Logistical challenges around shipping supplies are growing. Patients are increasingly less willing and able to get to and complete visits. The industry is scrambling to establish new and broader remote oversight strategies that a few short months ago were considered nice to have, and have now become essential.

Launching or expanding a clinical trial at this time means deploying valuable resources into a great unknown.

 

Here at ArcheMedX, we are following our own advice. We are pausing to ensure our business continuity plans fully support the potential scenarios we are facing, including a fully remote workforce. We are assessing for any single points of failure that require additional documentation or back-up resources to be prepared. For our customers, instead of storming full-speed ahead with new initiatives and launches, we are pausing to tighten up data integrations to ensure the broadest and most seamless access to our platform. And, we are polishing data reports and dashboards to ensure operational leaders have the fastest and clearest signals to more quickly make decisions.

In our current rapidly changing, highly-likely-to-be-disrupted environment, we encourage reflection before action. Pause and consider how you might put a more flexible, data-driven, risk-based model in place, a model that accomplishes a lot more work in what is often called a centralized way, but will now be more remote and dispersed. Consider digital solutions that push data and consumable insights into the right hands at the right time and give you signals about how your project team and site staff resources are doing before issues multiply. Ultimately, these efforts will save you a great deal of time and money going forward, and prepare you well for whatever new challenges may be in your future.

Putting the brakes on a clinical trial is certainly a big move to make. It won’t be easy and it won’t be painless, but if your ultimate goal is for your trial to succeed, pause it.