Savvy sponsors and contract research organizations (CROs) can leverage a staggeringly busy and complex regulatory landscape into a competitive advantage, says Amber Meriwether, JD, MA, Senior Manager in Contracts and Outsourcing at Astellas Pharma Global Development, Inc.
Many new or pending regulatory changes will be favorable to the clinical trial industry and patients broadly, Meriwether says. However, it still takes time and energy to recalibrate operations to adapt to a positive rule change.
The fresh array of new or pending laws and regulations is long and a bit intimidating, including the:
- 21st Century Cures Act
- Food and Drug Administration Reauthorization Act
- Murky status of the Affordable Care Act. Republicans on Capitol Hill have been working to “repeal or replace” the legislation, also known as Obamacare. Whereas, the Democrats’ Bernie Sanders has proposed “Medicare for all.”
- So-called “One-in, Two-out” Executive Order signed by President Donald Trump that requires an agency to cut two regulations for every new one it proposes. The new rule is being challenged in court so its fate cannot be determined yet.
- Adoption of International Council for Harmonization (ICH) Guidelines into U.S. regulations, including updates to the ICH E6 Guideline for Good Clinical Practice.
It’s time for all players to open their minds to new ideas. Regulatory changes and consolidation in the CRO/data provider space have enabled utilization of innovative trial designs, patient-reported outcomes, real-world evidence, and traditional data with fewer suppliers involved, Meriwether says.
Sponsors and CROs will have to adjust to new regulatory realities in countries outside the United States, too. For instance, Brazil, China, and South Korea all joined the ICH in the last year. “It could impact billions of patients,” Meriwether notes.
Sponsors and CROs need innovative ways of looking at each other, Meriwether also suggests. For example, as clinical trial regulations rapidly evolve, sponsors and CROs need to be able to quickly pivot in order to capitalize on opportunities. Sponsors may need to factor in the risk this creates for CROs in their payments.
Author: Michael Causey
Editor’s Note: Ms. Meriwether is a paid employee of Astellas. These comments are intended for informational purposes only and do not replace independent professional judgment. These comments are not intended to be legal advice. Statements of fact, positions taken and opinions expressed are those of the speaker individually and, unless expressly stated to the contrary, do not necessarily reflect the opinion or position of Astellas, or any of its subsidiaries and/or related entities. The speaker is not part of the Astellas Legal department and does not represent the position of the Astellas Legal department. The information presented was current as of drafting. The information may have changed as this is a rapidly evolving space.