Collaboration can fix ‘broken’ clinical trials model TransCelerate CEO tells CROs
Gill made the comments at Partnerships in Clinical Trials (PCT) in Barcelona, SPain this month, telling contract research and pharma industry delegates that working together to fix problems is key to simplifying and speeding up the drug development process.
“Individual company agendas are not going to solve the problems that we have,” Gill said, adding that through TransCelerate “there is this collective understanding that ‘I may have to give on something for the betterment of us all’ that is making that difference.
“It’s not that suddenly that everybody has become nice people, it’s that the pain [of not collaborating] is no longer bearable.”
Clinical trial execution is one area TransCelerate believes it can improve Gill said, adding that: “There is something fundamentally broken with how we conduct clinical trial process in particular” citing outdated methods, risk-based monitoring and comparator sourcing as key issues.
To improve the process TransCelerate – whose founder members include sponsors like AbbVie, AstraZeneca, Pfizer, GSK, J&J, Roche, Sanofi and B-MS – has commited to working with contract research organisations (CROs).
“One of the most important stakeholders in clinical trial execution is the CRO industry,” Gill said, adding that “clearly the vast amount of work [on trials] is done by biopharmaceutical companies CRO partners.”
To that end – in collaboration with the Association of Clinical Research Organisations (ACRO) – the organisation is developing a CRO forum that will invite contractors, including non-ACRO members, to collaborate directly with TransCelerate, Gill explained.
Trial site involvement
TransCelerate also works with organisations like the SCRS, the society for clinical research sites, to determine what those involved in trials day to day see as being the biggest hurdles.
“We are actively involving the sites in every one of our projects,” Gill said, adding that “we are not arrogant enough to tell clinical sites we know what your problem is. Instead, we ask the sites what the problems are and make sure that is what we tackle.”
He highlighted Transcelerate’s clinical trial site advocacy group as one example explaining that the idea is to seek input from people involved in running studies and to feed that information back into the organisation’s projects
This was echoed by Thor Voigt, senior vice president of global clinical operations at TransCelerate member Boehringer Ingelheim, who cited efforts to eliminate repetitive and duplicate training as one area in which the organisation is having a positive impact.
“It is a waste of time for a site, for an investigator, for a co-ordinator for a study nurse if they have to repeat the same training materials for company ABC and three months later for company XYZ when it comes with the same information.”
To address this, TransCelerate has established common accepted training certificates for staff Voigt said, explaining that 65,000 of which have already been issued adding “for the sites this means they can really focus on what really matters.”
Standardization of things like disease indications and inclusion or exclusion criteria is also a focus for sponsors according to Voigt, who said that: “Even for something like the definition of something simple like ‘moderate asthma’ you can ask five experts and get six opinions.”
Jonathan Zung, who heads global clinical sciences and operations at UCB, was similarly positive about the impact TransCelerate is having, citing the organisations ‘comparator network” as a key achievement.
“We’ve got a network where member companies can make transactions with other companies to buy both active comparators and placebos that can be used for clinical trials” Zung said, explaining that 10 member organisations regularly take part.
“What it really means is that you can buy a product directly from another member company and get all the analytical data, get the shipping information” he said, adding that one TransCelerate member had been able to identify the source of deviations during transport using the approach.