Removing logistical barriers to improve clinical trial retention
We all know how long and arduous the clinical trial road is for sites and sponsors – but what about participants? And could simply making life easier for them to some way to solving “the retention problem”?
With fewer than five per cent of all those eligible to take part in a clinical trial signing up, holding on to every single willing participant is crucial.
Yet the global average dropout rate for a clinical study is around 30%, carrying huge consequences for sponsors, sites and patients, not to mention society at large.
Jim Murphy, CEO, of clinical trial payment software company, Greenphire, said: “There are many different problems that this causes, but let’s start with the financial because it’s easy to measure.
“The average cost per patient in a clinical trial is $35,000 to $40,000, and that’s increasing. And approximately 85% of studies either fail to enrol or retain enough patients. This is a very real, tangible, expensive challenge.
“Drug prices are high, and it’s no mystery why when it’s so expensive to get a treatment approved. But if we can keep patients in the trials, we can have statistically significant data more quickly,” said Murphy.
The biggest issue, he added, is what this means for the advancement of research and the industry’s ability to bring safe, efficacious medicines to market in a timely fashion.
Two trends which have been building momentum over the last ten to 15 years have compounded the problem of clinical trial retention.
First, there has been a move towards collecting more data from each individual, resulting in a greater number of procedures being carried out during a greater number of visits.
At the same time, the emergence of rare disease treatments and targeted therapies has slimmed down the pool of eligible candidates.
“Longer, more frequent visits place a greater physical burden on the patient, and all the time more and more trials are looking for candidates who are like a needle in a haystack. That is creating a dynamic where the average distance that a patient lives from the clinical site is increasing significantly,” said Murphy, adding that this was happening across indications.
Retaining patients in this environment rests on providing them with more support and assistance, but this can be complicated, both in terms of logistics and administration.
As site staff work to coordinate time zones, transportation types and providers while considering local geographic awareness, and much more besides, they become less able to focus on the trial participant.
“If a patient feels they are valued and they are a have a personal relationship with the site staff, their retention likelihood is much higher,” explained Murphy.
“But there are a lot of burdens in trials that don’t just place stress on the patient, but on the site as well. They might be financial, or the time it takes to deal with lots of different systems and other non-protocol administrative and logistical processes.”
Dropouts, and the associated consequences for all stakeholders, are therefore, he argued, an obvious consequence.
“The combination of all these things mean you have folks who are donating their time but may not be able to continue to the end of the trial,” said Murphy. “They are not getting the full benefit of their sacrifice, and neither is society.
“Most people participate in clinical trials because they want something better to come from their experience, whether that is for them or for others. I think it’s unfortunate if you get halfway through then have to drop out because it becomes just too burdensome.”
Connection and logistics
Removing as many of these practical barriers as possible could well be the answer, said Murphy, adding that there was a lot of work currently happening in this space.
“There’s a tremendous amount of need and opportunity to ease every facet and problem, whether it’s the simple act of reimbursing somebody for parking straightaway or getting the patient and their caregiver across six nations, with transport, hotels and visas, to their visit.
“We can’t control protocol – protocol is what it is – but if you can take care of all those other elements of patient convenience in a way that actually reduces the burden on the investigative site, you’ve added connectivity and allowed more time for the site to focus on the patient.”
Removing these logistical burdens doesn’t only get people to the site on time with as little stress as possible, it, importantly, makes them feel valued.
Murphy explained: “You have these multiple layers of benefit because you are creating a situation where the participant says, ‘gosh, they’re willing to go the extra mile to take care of me. I’m not on my own’.”
The retention problem is a huge one, but the advent of digital health and med tech is presenting new and exciting opportunities, said Murphy, a molecular biologist by education.
He said: “I’ve spent my entire career trying to make clinical trials more efficient and effective so that we can, ultimately, bring treatments to market faster.
“There are a lot of great ideas out there, there’s an incredible boom of treatment innovation and that’s really exciting. It is challenging us to evolve the clinical trial process, which is historically so long and inefficient, so that it is better for everyone: the site, the patient and the sponsor.”