Sponsors and contract research organisations (CROs) often request trial sites submit patient recruitment estimates in a feasibility questionnaire, which evaluates which site is best suited to the proposed study.
However unless a sponsor is familiar with a site, it will normally deduct a percentage from the estimation to be on the safe side, said German trial site Fraunhofer Institute ITEM’s Philipp Bardorrek.
“We have heard from several companies that they normally deduct 50% [from patient recruitment estimates],” he told us.
“As a consequence, when I say, for a certain study, I can do five [recruit five patients], and I’m confident I can do five, and the company then believes it might be two to three, then it’s not enough patients for our site to be included in the study,” he said.
“And now I’ve got a dilemma: Can I convince them that five is reliable? Or should I say ten, so then they think I can do five? It is a vicious circle, because it always carries on like this,” he added.
According to Bardorrek, sponsors and CROs have learnt to err on the side of caution.
“I think they are just trying to be careful…if study recruitment numbers aren’t as it [the sponsor] thought they would be, it can have a big impact on studies.”
The consequences of miscalculating patient estimates can be severe, he added.
Time consuming process
Providing accurate recruitment estimates is a time consuming process, explained Bardorrek, who told us the process requires a good patient database and available staff to look into individual patient files.
Further, if the CRO requesting the feasibility questionnaire is not awarded the trial by the sponsor, a lot of this work can be futile, he told us.
At the Partnership in Clinical Trials conference in Amsterdam last month, CEO of Dutch site Julius Clinical, Hans van Dijk, agreed the patient recruitment process is time consuming.
“The industry as a whole has usually made trials more complex and more labour intensive, which has made it much harder on sites to recruit patients, to be able to make the time available to recruit patients,” he said.
Unreliable and ubiquitous?
While Doug Peddicord from the US Association of Clinical Research Organisations (ACRO) said it would be “overly strong” to assert that sponsors and CROs no longer believe recruitment estimates, he agreed this aspect of the feasibility process can be problematic for invested parties.
“The problem of accurately estimating potential clinical trial participants has indeed been ubiquitous and longstanding for sponsors, CROs and sites.
“Each of the stakeholders very much wants to find eligible patients, but the processes for doing so have too often been unreliable,” he told us.
Peddicord said increasingly, research organisations have systems in place to improve estimates and patient numbers.
“CROs are deploying a broad array of big data and predictive analytics to improve feasibility estimates, and to assist sites in identifying eligible patients.
“I would anticipate that in the next three to five years, such tools will be increasingly accurate and the problem of ‘guesswork’ feasibility estimates will significantly reduced,” he added.