Bridging the gap between global trials and regional processes
Regional differences in processes and regulations are compounding the challenges of 21st century clinical trial management. Is greater standardisation on its way, and what can sponsors do in the meantime?
Clinical trials are increasingly global affairs, but sponsors managing multi-region studies have multiple sets of regulations to contend with.
While there has been some movement towards standardisation, it remains a significant challenge for organisations attempting to conduct robust trials in a world of precision medicine and patient centricity.
Kyle Cunningham, chief product officer at Greenphire, says: “There is a lot of commonality in the macro-level challenges and trends across broad geographies such as the US and Europe, but there are differences from region to region as it relates to regulation, business practices, culture and languages.
“European rules and requirements can vary quite drastically from country to country, even within the same broad region.”
The rise of precision medicine means the medical community is looking for a “virtual needle in a haystack”, he says, contributing to issues with enrolment and retention.
“It’s a really exciting time for drug development, with more precise treatments targeting more narrow patient populations. But the reality is, that precision and complexity create additional burdens for all stakeholders involved – none more important than the patients.
“They often need to travel longer distances and spend more time in the clinics. As a result, there is a recognition – I’d go so far as to say a movement – towards making trials more convenient for patients.”
This shift has seen the emergence of greater patient involvement in areas such as protocol design, and siteless or hybrid trials which replace clinic visits with virtual data collection, allowing people to take part from the comfort of their own homes.
Sponsors are attempting to adopt such practices without placing additional burden on site staff, not to mention within the confines of varying sets of rules and processes. This has business consequences.
“There is a large challenge related to process control visibility of spend that is accentuated by extensive fragmentation,” says Cunningham. “Fragmentation of process and technology can greatly emphasise the difficulties in understanding and controlling R&D-oriented spend.”
Such variances compound the more general challenges of running studies on a global scale, making it more difficult for sponsors to pursue opportunities that are focused on patient convenience and site centricity.
Moving towards harmonisation
There have, certainly in Europe, been efforts to harmonise procedures and regulations. There has, for example, been a focus on the consistency and standardisation of ethics committees and their processes, at least at the country level.
GDPR has standardised the protection of sensitive data, and the EU VAT Directive will harmonise invoicing, an area Greenphire and the Society for Clinical Research Sites has identified as ripe for change.
“We surveyed 100 European sites on invoicing and payment processes. The responses confirmed that the majority of sites in Europe would prefer to be paid monthly rather than quarterly, and that those sites would also prefer to work with sponsors and CROs who automate and streamline payment processes,” explains Cunningham.
Movement, however, is slow, and keeping pace with evolving standards and regulations across regions and territories is an administrative burden in itself.
“All the areas being looked at represent opportunities for greater standardisation, but they also force stakeholders to understand the requirements and ensure solutions and process that adhere to them,” Cunningham says.
The role of intelligent tech
He believes that emerging clinical trial technologies could hold at least part of the solution to embracing patient centricity without placing extra burden of site staff.
To make them attractive to research sites, such systems have to be “mature enough to align with regional requirements and preferences”.
He adds: “Additionally, sites may be guarded when new technologies are introduced, because they are often using many different systems already. But I think that European research sites embrace technology when it’s clear that it actually works in their country, that it understands the local regulations and business processes and can make their and their patients’ lives easier.
“I’ve talked to a lot of sites in a lot of countries, and I’ve never talked to anyone who would turn down an opportunity to utilise technology that added real value. In fact, most sites are more inclined to work with sponsors and CROs who provide empowering tools. They just want to make sure it can actually accommodate their local needs.”
As we move ever deeper into the realm of personalised medicine, patients and sites will be increasingly spread across the globe. The challenges of conducting cohesive, singular studies within the confines of varying sets of detached regulations and processes are not going away. Solutions, whether regulatory, workflow or a mixture of the two, then, are essential.