PCT Europe 2015
Big Pharma; Big bureaucracy; Big trial delays, says PCT panel
There was a distinct focus at this year’s Partnerships in Clinical Trials event, with the Hamburg, Germany audience being told how trends such as patient-centric studies, technology innovations and new sponsor-CRO models could increase trial efficiency.
But one area questioned was Big Pharma’s role in speeding-up trials, and during a keynote session a panel of sponsor representatives said the disconnection between the different departments within a large pharma firm led to bureaucratic delays and ultimately restricts the start date of trials.
“There are a lot of moving parts from a lot of players involved in running clinical studies, and the studies themselves are actually only one component of a much larger development programme,” said Barbara Tardiff, Pfizer’s VP of Development Operations for its worldwide R&D.
She added a sponsor needs to have a holistic view of trial management. “It is complicated but that doesn’t mean we can’t tackle the complexity and manage it, but it does require having both good ideas from the grassroots [of the sponsor organisation] as well as support from the leadership.”
Bayer’s VP Global Head of Startegic Sourcing R&D Vanessa Cooke agreed there is an amount of waste that is reducing trial efficiency.
“We do tend to debate things; we do tend to make hard work of simplistic approaches,” she said, but added pharma can learn from their contract research organisations (CROs). “We should really take some instructions from our suppliers who actually would like to get things done much more quickly.”
Bureaucracy for the sakes of bureaucracy?
Grunenthal executive Graham Belgrave, however, was less convinced bureaucracy - if defined as an unnecessary function - is holding back clinical trials, as these processes are necessary to fulfil regulatory demands and ensure patient safety.
“We do what we are required to do by the regulators; we’re not hiding behind the regulators but there is an increase in demands,” Belgrave, who heads the Global Clinical Development Science & Operations at the Germany-based pharma firms, said.
While trial protocols in pharma’s distant past were fairly unregulated and therefore quick to design, “we now of course have to have the checks and balances in place and it’s quite rightly that we do for patient safety,” he continued.
He did concur there may be opportunities to increase efficiencies, citing as an example how pharma’s differing GCP pre-qualification training programmes differed, slowing down trial start dates as CRO study site staff often need to be retrained each time a new sponsor is brought in.
Thus industry groups like Transcelerate – a pharma led collaboration to aid trial design and facilitation – could offer solutions to such burdens, he said. The group has already implemented a scheme to standardise and share GCP training across its Big Pharma members.