Changes taking place in the United States and internationally may affect the clinical trials landscape in the months and even years to come. Here are a few observations:
FDA
The U.S. Department of Health and Human Services is reducing its workforce and streamlining its functions. It released a fact sheet regarding changes to expect, which include a workforce reduction at the FDA. Studies conducted by sponsor companies are largely free of direct impact; however, the FDA’s restructuring may affect timelines regarding approvals of studies and new drugs.
Tariffs and the Clinical Trials Landscape
While pharmaceutical products are exempt from the enacted tariffs, medical supplies essential for conducting clinical trials—such as gloves, needles, syringes, and monitors—are not.
With a temporary 90-day pause currently in place for many tariffs—though tariffs on goods from China remain active—sponsors have a window of opportunity to review sourcing strategies and strengthen trial planning. Imperial remains ready to help teams navigate these evolving conditions.
Tariffs can potentially drive up the costs of imported goods for at least the short term. They can also drive up the costs of goods imported into other countries worldwide that may be shipped there as part of a clinical trial.
According to 2019 data from the Congressional Research Service and reported by the National Institutes of Health, the leading countries for medical supply imports in the U.S. are Ireland, Germany, China, Switzerland, and Mexico. Some countries are exempt from additional tariffs for now.
There will likely be some process-related delays as federal agencies that impact trade and logistics put tariffs in place and ensure enforcement mechanisms are active.
Clinical trial operations teams will need to be vigilant in assessing the impact of cost and time on their study budgets and timelines.
As tariff negotiations evolve, it will likely make local sourcing for clinical trials a priority. The research and testing needed to find suitable equipment and supplies may lead to delays in trials as sponsors test and acquire protocol-compliant supplies.
Our sage advice is always to plan ahead whenever possible to avoid disruption. And it’s even more important today to:
- Begin trial planning early
- Add buffer time to study ramp up activities
- Set aside contingency budgets that are approved and in the purchase order
Final Thoughts
As the landscape continues to evolve, each day presents us with fresh developments and opportunities. We anticipate further adjustments and ongoing course corrections. At Imperial, we are closely monitoring these changes and stand ready to guide you through this dynamic landscape, providing tailored recommendations and strategic pivots whenever necessary.
We encourage you to stay connected with us and share your insights as we navigate this journey together. Your feedback is invaluable; together, we can shape the future of clinical trials. Let’s embrace these changes proactively and drive innovation forward!