Last week Zoe Doran – head of clinical research for the English University’s diabetes trials unit – told attendees at PCT Europe about the difficulties faced in the on-going Acarbose Cardiovascular Evaluation (ACE) end-point study in China.
She said a lack of connection between hospital sites and therapeutic departments means many trials “crash and burn”, and that the situation is off-putting for contract research organisations (CROs).
“People don’t talk to each other there,” she said. “There is no connection between departments in the same hospital site, so it’s especially difficult to get communication between the therapy areas on different hospital sites.”
Big differences in the way CROs run clinical sites also present issues for sponsors, for instance in trial funding. Doran explained that giving funding to a site does not necessarily mean they will resource the study as in any other country, and that access to money is not limited to an administrative overhead.
“This admin site could take the whole lot. Or if they’re going to give money to the study team it won’t be until the end of the trial,” she said adding that physicians may even syphon money considering it “additional income rather than extra funding.”
Poor stability in local CROs, which have a tendency to change clinical research analysts (CRAs) every three months, also hinders sponsor-vendor relationships.
Problems in data collection
Doran said another major communication problem lies in the fact Chinese patients hold their own records rather than the hospital, which means data access can be stunted.
She said that though trial sites try to solve the problem by taking photocopies of the records, patients could get admitted to other hospitals – for instance in an emergency – which poses a problem for data collection.
As clinical data is not equivalent to evidence found in the West, and “sourcing high quality data is difficult” researchers often have to report the study on two levels – local and international.
Working through it
Anja Mollmann, senior project manager at Theorem – the CRO working with Oxford Univeristy on the ACE trial – said one solution to the problems is paying individual attention to each trial site.
“It takes time until you have a good relationship established and only then you get the answers.”
And though the trial is the largest end point study ever carried out in China – with 5,000 patients recruited over 143 sites so far, and an end goal of 7,500 – Mollmann believes the effort is worth the pay-off.
“The engagement of the site is very important if they are to acknowledge they need to meet international standard for clinical trials.”
Mollmann also said educating doctors and patients about the need to share information more freely, and why clinical trials are important, is a necessity if CROs are to see success in China.