Clinical research staff shortage – a growing crisis to CRO industry but addressing specific gaps may ease liabilities
The CRO industry’s acute understaffing issue is likely to become more of a burden to sponsors and CROs as trial volumes increase while recruitment stagnates, said experts. While the issue — not enough qualified, experienced clinical research staff globally — has no clear immediate fix, several industry schemes may partly alleviate specific training gaps in the long- term, they said.
John Lewis, spokesperson, Association of Clinical Research Organisations and other experts agreed there is an acute global shortage of trained staff in clinical research, particularly for clinical trial associate (CTA) and clinical research associate (CRA) roles. Yvette Cleland, CEO of recruitment agency Clinical Professionals in London said the problem has been amassing for more than ten years, with neither pharma sponsors nor CROs providing enough skills training to recent graduates to meet the drug industry’s research needs.
Cleland stated large pharma has historically taken on large cohorts of recent graduates to train them, but this practice ended with the boom in outsourcing 10-15 years ago. More than 80% of clinical research staff now work for CROs and functional outsourcing organisations, rather than in-house at pharma companies, said Jim Kremidas, Executive Director, Association of Clinical Research Professionals.
However with CROs making 50% less margin now than five to six years ago, they cannot afford to take over all the necessary training of researchers, Cleland said. Leaving a gap with neither pharma nor service companies funding the entire training burden. Compounding the problem, when CROs invest in employee training, skilled employees are often poached by rival CROs “and so the cycle continues.”
Kremidas said the industry needs to create a standard pathway into clinical research, since current ad hoc training, inconsistent background and routes into the industry is lowering the quality of clinical research. A source at a UK site management organisation (SMO) which employs clinical research staff said the staff shortage is slowing trial enrolment times and probably preventing access to patients. Projects which recruited high numbers of patients sometimes cannot enroll them in a timely manner because of a lack of clinical research staff, said the source.
Pharma could bring CRA roles in-house
Cleland said CROs have shifted to employing a far larger number of freelance staff, who often cut back on their own training and development, contributing to the problem of undertrained staff. Freelancers are also more expensive to hire than permanent staff. Around 70- 75% of the cost of clinical drug development is salary, she said, adding this figure is escalating year-on-year.
Freelancing has driven up salaries, meaning CROs are not bringing in new staff as a result, said Cleland: “we’re fishing in the same limited pool”. Kremidas said pharma is now trying to bring more trial work in-house to take back control of drug research, but Cleland said this puts pharma in competition with CROs for staff, and given the rise in salary for freelancers, she said it is uncertain whether pharma can afford to. Kremidas said sponsors are now more willing to bring less experienced staff in-house if they are managing them directly – unlike staff provided by a CRO – so they can keep a closer eye on them.
Cleland and Kremidas said CROs face a dual recruitment burden: fixing the existing problem of sourcing enough qualified staff for current contracts, while also needing to “future-proof” their businesses by hiring and training technology-proficient employees with skill sets ready for future data-driven trials. Staff who can analyse large data cohorts to identify underperforming sites will be particularly needed in future, said Kremidas. Some advances in standard operating procedures may ease CROs’ staffing burden, he said: as trials move towards a risk- based monitoring paradigm – as this news service previously reported – this may free up staff from site visits and help alleviate the shortage.
Cleland, Lewis and Kremidas said Service Level Agreements (SLAs) between trial sponsors and CROs often require CTAs and CRAs to have two to three years’ experience, excluding recent graduates from breaking into the industry. Kremidas and Lewis said ACRP is working with a cross-industry task force – including ACRO, Pfizer (NYSE: PFE), Celgene (NASDAQ: CELG) and Biogen (NASDAQ: BIIB) – to develop eight CRA competencies that can be accepted on SLAs instead of years’ experience, including around regulation, trial operations, and informatics.
ACRP plans to extend this scheme to other clinical research roles in future, said Kremidas. The SMO source said the skills gap problem could also be addressed by having clinical research teams overseen by senior CRAs to mentor junior apprentices, a practice that has been cut in recent years because of squeezed margins, and experienced staff leaving CROs to freelance instead of entering management. Cleland said Cogent, the UK’s strategic body for science skills, has cut funding to apprenticeship programmes, but her own company Clinical Professionals began a scheme last year which trained 15 graduates and placed them in CRA and CTA roles in pharma, CROs and medical technology companies.
But any progress addressing the problem will be slow, said experts. Training schemes will take at least three years to bear fruit, said the SMO source, while Nick Sljivic, Managing Director, clinical staffing company IMS Recruitment in Cheshire, UK, said global demographic trends suggest 10-20% of clinical staff will retire in the next ten years, with not enough fresh graduates to replace them.
by Fiona Barry in London
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