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At-home clinical trial services are a relatively new niche market. A quick search brings up only a few vendors. One, Medical Research Network (MRN), is based in the United Kingdom and has only recently announced it would establish a presence in the United States by opening up an office in Raleigh, NC. Another UK-based company, Illingworth Research and Research Nurses Ltd, offers a home care agency with a research component; and Coram, primarily an athome infusion service and specialty pharmacy distribution company, also contracts with sponsors to visit trial patients in their homes or work places.
“Sponsors are just beginning to wake up to the benefits of going directly to the patients,” says Nicki Norris, CEO of the Chicago-based Clinical Resource Network, one of the oldest companies in the group. They also extend their reach by contracting with home health agencies globally.
Norris talked recently to Applied Clinical Trials about why and how the trend for at-home clinical trial services is finally catching on and its impact on retention and recruitment.
Q: How long has CRN been in service?
A: The company was actually founded in 2003. Our founder worked in both clinical trials and in home care. We’ve really been perfecting our process ever since. There are a lot of moving parts and a lot of people involved in this kind of service. So having a process, the metrics, and the support to make it all work is incredibly important.
Q: Has your concept changed from then until now?
A. Yes, and it has to do with market changes; our understanding of what is necessary; and how we provide it.
Q: Tell us about the effect of the market changes.
A: Before the economic pressures of 2007 and 2008, drug development tended to protect its clinical trials and its research people. In the aftermath, players in the marketplace have had to open up more and be willing to look at new ideas. In addition, the FDA is placing stricter requirements on how a trial should be done. One of those in particular has to do with getting a representative patient population or getting an intent-to-treat pool that is similar to the pool that will actually have the drug used on it.
Typically, there are populations that take part in a clinical trial and there are populations that don’t, for a lot of reasons. When you try to get a representative sample of the population in your clinical trial, you have to do some things differently. To get the trial to those people at-home service helps.
Q: Could you expound further on how bringing a trial to the patients aids the sponsor with recruitment and also retention issues?
A: Say you’re a sponsor and either the study itself or the trial design, or the patient population you’re appealing to presents a difficulty. It can be as simple as needing adults to go to a site, 20 days in a row, twice a day, and even if they’re active, that’s a real pain over 20 days. And so the challenge can be in the design; or it can be the patient population; or it can be the geography of the patient population. In short, enrollment can be challenging.
Q: How then does an at-home service make sense?
A: Rather than designing the study for the efficiency and the convenience of the researcher at the trial site, the sponsor can include an in-home or alternate site service in their study. It shows they are really taking into consideration the needs and the convenience of the subjects. It doesn’t need to be for the entire trial. Typically, it’s a complementary service that focuses on visits that don’t require a physician; visits that are a simple blood draw done by a nurse, but it can end up being a tremendous advantage and time-saver to the patient. For the more sophisticated visits that might require an MRI or some sort of instrumentation that can’t be taken into the home, you can have the patient travel to the site. This then becomes an incentive and it will attract more to enroll in the trial.
Q: How does it help retention?
A: It is likely that the nurse or clinician going into the home creates a bond between the patient and the caregivers. This, in turn, appeals to the subject, makes him or her feel more involved and cared for, and helps them to stay in the study.
Q: Can you tell me why home-care service is just catching on?
A: Sponsors are being forced to think about outsourcing, about mobile trials. I just spoke at a conference, and there were several people there that said: “Wow, I didn’t even know this existed.” They just didn’t think about it.
Q: In terms of retention rates, do you have data that indicates the success of at-home trial services?
A: There’s a retention study on our site (http://www.clinicalresource.net) that shows the drop out rate for patients who used home care. I believe it was 3%, and for patients who didn’t use home care was like 63%, and on average the study looked as if had a 24% drop out rate, which is pretty close to average. But when you go behind the numbers one step further, you see the differential was convenience. We have data that demonstrates in key studies where our services were able to make trial participation more convenient, patients did enroll, and it changed the timeline for enrollment, which obviously results in time and money for the sponsor.
Likewise, there are case studies where some patients chose to stick with only visits to the site. While some patients chose to use home care. There is a radical difference between the two groups in retention or drop out rate.
Q: Where are your services offered worldwide?
A: We are a huge contracting organization, with subcontracts with about 250 accredited home-health agencies in the United States, Canada, UK (England, Ireland, Scotland), Spain, Italy, France, Germany, Netherlands, Belgium, Sweden, Denmark, Poland, Switzerland, Czech Republic, Austria, Israel, and Australia. The company works on 40 to 50 studies at one time, mostly for big pharma and large CROs. We typically contract with whoever is running the study. If it’s the biotech company, the pharma company, the CRO, any of those, and we develop our services very much for an individual study, and once that contract with the sponsor is set up for the study, then we go into action with the sponsor, with the lab, with the pharmacy, all the people involved, and we develop exactly how our services will be delivered, how they will be used, what kind of clinician is needed, and how the clinician will be trained.
Q: Earlier we were talking about what has changed in your operation. Can you think of anything else?
A: We’ve been doing a lot of work on the at-homes service’s value to the site. Sometimes sites are reluctant, from a financial perspective, to get into the home care situation, and yet one case study shows that some sites elected to use home care, some sites did not. But the ones that elected to use in home services, i.e., made it more convenient for the patients to have many of the visits in their homes, it enrolled three times more than the other sites.
Another study, concerned a rare disease and they were covering patients in 15 states. So we were able to facilitate that obstacle by going into homes all across the United States.
Recently I was at a site summit in Florida focused on principal investigators. And all I had to do was say the word "snowbird," and these people were all over me. Right now snowbirds leave for Florida for six months of the year, ordinarily they would have to be disqualified from their trials, but with our service we could follow them to Florida. So, in the end we’re bringing together four things: detailed project management skills, clinical trials knowledge, nursing, and home care services.