U.K.-based Medical Research Network (MRN), a five-year-old company that arranges for clinical trial participants to be seen in their homes rather than requiring them to travel to an investigative site, recently announced it is establishing a presence in the U.S. via a new office in Raleigh, N.C.
This niche sector of the market already contains Chicago-based Clinical Resource Network, which contracts with home health agencies around the world to visit trial subjects in their homes; Clinical Development and Support Services, a home care agency with a research component; and Coram, primarily a home infusion services and specialty pharmacy distribution company that also contracts with sponsors to visit trial patients in their homes or work places.
But Graham Wylie, CEO of MRN, says there’s definitely room for one more. A number of sponsors and CROs still aren’t aware of the concept, he said, and many of those that are consider it useful only for study participants who are homebound and can’t physically travel to a study site.
The concept, said Wylie, can be used much more broadly than that. MRN markets the service as helpful when the administration of the study drug is very complicated or time-sensitive. It can also be used for patients who are traveling or who have relocated while a trial is underway. And some sponsors recognize that using it to make trial participation more convenient can result in better retention.
“Our position is that anyone can benefit from this,” Wylie said. “The basic concept is: patients will participate in a clinical trial for a variety of reasons, altruistic or otherwise. But they always balance that out with the hardship the trial causes for them. If patients learn that they only have to come to the hospital five times a year instead of 10 and for the rest of the visits the trial will come to them, they are more likely to consent.”
Wylie said MRN’s internal numbers show the service increases enrollment by about 60%. For very complex studies, he added, enrollment can rise by as much as 10 times.
An example of a complex study, he said, is one in which the product is a biologic that must be compounded in a compounding unit on day zero, stored under very specific conditions, transported to a hospital, picked up by a nurse and then taken to a patient’s home, where an infusion is set up, blood samples are taken during the infusion and a case report form is filled out.
Five years ago, MRN was spun off from U.K. home health firm Healthcare at Home, which specializes in administering complex medicines to patients in their homes. To engineer the spin off and then head MRN, Healthcare at Home hired Wylie, who had worked in leadership roles at both Pfizer and Parexel.
MRN has grown from annual revenues of $400,000 at its inception to the company's projection of just under $5 million this year, said Wylie. MRN operates primarily through partnerships with organizations that have nurses, including home care agencies, staffing firms and hospitals.
The service, which is available at any hour, is not cheap, said Wylie. Sponsors and CROs pay by the unit, or visit, which can increase their per-patient cost. But because recruitment and retention speed up and improve, the service can bring down the overall cost of a trial by 15% to 20%, he said.
So why aren’t sponsors and CROs leaping at it? Because they are slow to change, said Wylie. “It’s a new idea. The whole sector is always trying to innovate, but pharma companies are conservative by nature. Innovation can be hard to stimulate.”
Nikki Norris, CEO of Clinical Resource Network, which has offered much the same service since 2003, said she attends conference after conference talking about the concept, and though many of the top 10 CROs and sponsors use her services, huge swaths of the industry still aren’t aware of it. Much of that has to do with how the industry is divided into separate silos, she said.
“A drug sponsor may use it in one therapeutic area, but the rest of the company may not know it exists,” said Norris.
But Wylie said something of a perfect storm may force such changes soon. “As more biotechs come along with complicated projects and the economy continues to squeeze pharmaceutical companies’ R&D budgets, everyone’s looking for ways cut costs while improving recruitment and retention,” he said. “This may be what they look to.”
“This is a developing market that could just grow and grow,” he added. “I really don’t see it having any sort of cap. Almost any trial will speed up if you can get your arms around it sufficiently by having enough patients.”