Executive Director, Global Regulatory & R&D Policy, Amgen
Demands for global regulatory alignment in the clinical trial space have been brought sharply into focus in recent years, particularly against the backdrop of the COVID-19 pandemic.
While regulators have a common responsibility to ensure that clinical trials are executed ethically, effectively and safely, different approaches may exist in different countries.
But as clinical trials recruit from a broader patient base, facilitated by remote technologies and a shift towards decentralised trials, the need for closer global regulatory alignment has fallen under scrutiny.
Ginny Beakes-Read, Executive Director (Global Regulatory & R&D Policy) at Amgen says: “When you have many different regulatory approaches, it makes it challenging to execute global clinical trials and, therefore, get products to patients effectively and efficiently.”
According to Ms Beakes-Read, to achieve the potential of innovative clinical trial designs, and of innovative trial approaches – such as hybrid or decentralised trials – we need to have more global alignment of regulatory expectations, still anchored in the principles of mitigating risk to participants and maintaining trial data integrity.
Although regulatory authorities may adopt different approaches based on unique needs of their populations, there is a pressing need to understand where the regulatory process can be more closely aligned, she says, with more progress needed in this area. For example, with respect to whether alternative methods of obtaining informed consent are permitted, we found that some regulators allow it, some require advance notification or approval and some have not yet addressed the issue.
When you have many different regulatory approaches, it makes it challenging to execute global clinical trials.
The pharmaceutical industry acknowledges that regulators are working to better align approaches and that regulatory flexibilities during the COVID-19 crisis delivered learning points as a foundation for modernising clinical trial conduct. This includes greater use and regulatory acceptance of digital tools, decentralised approaches, telemedicine and modern statistical methods.
“The pandemic was a natural experiment we had to go through, and we can use that to galvanise our forward-looking thinking, about how we plan trials for the future and modernise the regulatory system,” she continues. “We have learned, but we also need to eliminate barriers.”
Ms Beakes-Read believes there is a will to move forward in further aligning regulatory approaches, but that there is still a long way to go. In the meantime, trade associations, consortia, and companies are sharing experiences to help establish a way to move forward collectively.
“Building on the experience from the pandemic will help us to shape modernised clinical trial approaches and to promote clinical trial innovation,” she adds. “For the regulators, it is about how they can help contribute to sustain or empower and catalyse this potential innovation. It is about education, discussion and awareness.”