Much of the conversation around partnerships and collaborations in clinical trials revolves around improving the relationship between sponsors, CROs and external vendors, but it is also claimed that the way all of these groups work with study sites could need an urgent, industry-wide rethink.
Increasingly complex studies, slow payment and a lack of recognition and loyalty towards experienced sites are among a number of issues that are leading many good sites to turn their backs on commercial research entirely.
Kate O’Brien, senior research nurse at Albany House Medical Centre in the United Kingdom, conducts commercial primary care Phase 2-4 studies since 1999, and she believes that when studies are being designed, there is room for sponsors to collaborate more with experienced sites.
“I think because we are on the ground, we have a good perspective on the way studies work,” says O’Brien.
Dr Bettina Bergtholdt, chief executive officer of Emovis, thinks more studies should be designed in collaboration with sites – with a patient-centred approach in mind.
“Consider the advantages for patients if they take part in the study – if there is no advantage, why should they take part? Either a therapeutic or a financial benefit is necessary, and the feasibility of study procedures in daily life of patients should also be considered,” she said.
The costs eating into profit margins
Aside from missed opportunities for collaboration, sponsors still seem to be far from understanding the needs of their site partners. As an example, O’Brien says she might complete ten time-consuming feasibility studies before being awarded one, and that’s not the only thing that takes up her time.
“With all the costings, negotiating contracts, doing all the paperwork and looking for patients, it takes an awful lot of time before you can actually get to the bits you’re actually getting paid for,” O’Brien says.
She doesn’t believe that the setup fees really cover the actual costs of setting up a study.
“I think that now a lot of studies are getting over-complicated, they’re not practical and they’re not patient-friendly, so they’re almost becoming too much trouble,” she said.
“There’s also an unreliable study flow - it’s very difficult to keep a facility manned with staff if you don’t know when your next trial is coming through, so what we need is a constant reassurance of work.”
O’Brien also remarked on the trend for slow payments. “You’re paid at the end of the quarter, so you’ve got to do three months’ work before you see any return,” she pointed out.
Dr Bergtholdt has similar problems in Germany. “Too much work without payment is requested by sponsors and authorities,” she says, pointing out that up to 10 hours of training per staff member can be required for each study. This endless demand for training is something Dr Bergtholdt considers as a ‘frustrating’ waste of time and resources.
“It is required from sponsors and authorities but does not improve the quality of data,” she explains. “Only the certificates are needed, but nobody seems to think about a real effect on learning.”
To some extent, O’Brien agrees:
“Some of the web-based ones are an absolute waste of time,” she said. “You need face-to-face training. You need someone coming out to a site, sitting here and making sure the equipment works, that staff members are confident using it. It’s often just a voice droning on and on, and without the equipment in front of you it’s pointless.”
The high turnover and professionalism of clinical research associates (CRAs) also seems to be a sore point for sites.
“If you start a study you want a good CRA with you for most of that study, not frequent changes, and also there are sometimes language barriers coming into it as well,” explained O’Brien. “If you’ve got data queries and you’re trying to explain the answers to a CRA who really isn’t understanding you… it becomes very difficult.”
“ CRAs cost the sites a lot of money and there’s no compensation from anyone,” Dr Bergtholdt agreed.
New technology, lack of hands-on training
In light of growing trends to bring wearable technology and mobile apps into clinical trials, O’Brien says the technological demands made by many studies are often too much for site staff to cope with.
“New technology is being brought in and it is a very good idea, but we need support because we’re not IT geniuses, and we have to train the patients - who are often quite elderly - but we’re not getting the training ourselves,” she said.
“Some help desks are good, but some are appalling - there are some really, really unhelpful help desks! If they’re going to use technology it’s got to work, it can’t keep going down and not being available. And upfront we need the training, not just a quick going-over at the investigator meeting.”
Oversight and impossible demands
O’Brien says it is not often that issues between sponsors and CROs affect sites, but says it can be a problem when sponsors put pressure on CROs for missing information.
“For example, if we’re trying to get a response from secondary care but we’re not getting an answer, it doesn’t matter how much the sponsor hassles the CRO, we still can’t get that answer,” says O’Brien.
“We have a very good relationship with our local hospital, so if we have an SAE, they provide us with all the patient notes. Other hospitals aren’t that good though, and sometimes we have patients admitted when they’ve been away on holiday, and we can’t get the information, and it doesn’t matter how much the sponsor asks for it.”
For O’Brien, the time and effort she puts into her work might be more rewarding if sponsors and CROs had a better way of rewarding good performance from sites.
“I think it would be nice if good sites were recognised, if you recruited patients fast, if you met your targets, that some sort of bonus might be included in the payment scheme,” she suggested, adding that sites recognised as good performers could also be given a more predictable assurance of workflow, both for the longevity of their business and to form closer relationships with sponsors.