Speaking at PCT Europe, Zoë Doran – head of clinical research for Oxford’s diabetes trials unit – said contract research organisations (CROs) struggle to maintain their workforce because clinical research associates (CRAs) change their jobs so frequently.
The high demand and low supply of CRAs, she said, provides the perfect environment for staff to change places as much as every three to six months.
Doran added that the high turnaround rates can be detrimental to studies, because clinical research sites do not have long enough with CRAs to develop a good working relationship.
Lack of stability is also an issue for sponsors, she said, before asking: “When the CRAs change all the time, how can you develop good relationships with the site?”
The only way to solve the problem is by seeking those CRAs with more staying power, and by recruiting more professionals into the industry, Doran said.
“The solution to this lies in the hands of the Industry who need to stop employing people who will not stay and actively recruit more CRAs, the potential population of well-educated Chinese to recruit into the industry is huge.”
As for improving trial activity in China in general Anja Möllmann, senior project manager at Theorem – the CRO working with Oxford Univeristy on the ACE trial – added that site engagement is the key.
She said one reason the ACE study – 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 – has been successful is because Theorem evaluated the individual needs of each site.
"We looked at whether they need more CRA time on site, a research coordinator, special training, do they prefer visits in the morning or night shift?" she said. "The entire monitoring strategy, everything is a dynamic plan per site."
Though the process was labour intensive, Möllmann said the payoff is worth it because “the engagement of the site is very important if they are to deliver and meet international standard for clinical trials.”
Doran added: “China is a new and exciting, though challenging country, and the clinical trial community is keen for insights as to how to meet the challenges of working there.”