With recruitment for clinical trials being tough and retention being even tougher, some are taking recruitment efforts and patient visits directly to the community, instead of waiting for volunteers to come to them.
The Health Research Bus (HRB) has literally taken clinical trials on the road. Recently developed in the U.K. by an alliance between the Universities of Birmingham and Warwick, this mobile clinical research facility drives to areas where patients are clustered—retirement communities for dementia studies or schools for pediatric trials—and allows the patients there to be seen by coordinators and principal investigators on the bus.
“We started it because we live in a very big, multicultural city—a city that’s divided in terms of socioeconomic status and people’s ability to access health care,” said Una Martin, program director of the Wellcome Trust Clinical Research Facility, a body that provides facilities for investigators doing clinical research, including the research bus. “We worried that we were missing out on opportunities to include certain groups in research because they were having difficulty getting to the hospital or to general practices.”
The bus had its maiden voyage in March, and so far it’s working well. Martin said to increase awareness about clinical trials and help the public become more comfortable with the concept, the bus went to a bustling open market. People were free to climb aboard, meet the coordinators, a principal investigator and a lab manager, and tour the facility, which includes a waiting area, an exam room, a lab, a DXA (bone density) scanner, a bathroom and a kitchen.
In its one day at the market, said Martin, the bus doubled enrollment for a vasculitis study that needed DNA samples from healthy patients. In addition, about 200 people inquired about a blood-pressure study. The plan is to make such outings once a month.
The bus—the size of a semi-tractor trailer at 44 feet long and 21 feet wide—took about two years and $400,000 to build. It was funded by the Birmingham Science City Partnership and the Queen Elizabeth Hospital Birmingham Charity. Thus far, the studies being undertaken via the bus are those already in progress at the universities. But Martin said the bus is open for business and hoping to attract commercial drug developers. “In due course, we would like the bus to be self-funding,” she said.
In the U.S., no such research buses exist, but a few companies are bringing visits to the patients. One is Chicago-based Clinical Resource Network, which contracts with home-health agencies around the world to visit trial subjects in their homes.
“The concept is really basic,” said Nicki Norris, the eight-year-old company’s CEO. “If you make it easy and convenient for the patients, they are much more likely to participate. That can become really important if there’s a complicated study design or the population you’re trying to reach is difficult.”
For example, she said a Tennessee patient with a very rare disease did not like to fly, but researchers in Connecticut wanted him in their study. Clinical Resource Network connected with a home-health agency near the patient, which sent a registered nurse trained in GCP to his home for his study visits.
Home visits like this work well for people who have recently had surgery, have mobility issues or have dementia. It’s also warranted for some studies in which the treatment demands of the protocol are rigorous. Norris recalled a dermatology study in which patients were required to apply a cream twice a day for 20 days. Having them show up at an investigative site 20 days in a row wasn’t feasible, so the sponsor had Clinical Resource Network send a nurse to the patients’ homes each morning and evening to make sure they were following instructions.
Retention rates can skyrocket as a result. Norris said in one particular study, the dropout rate among patients being seen in their homes was 3%, compared with 67% for those being seen only at sites. Part of that is the convenience, and part is due to the patient-nurse relationship that builds over time.
“When a nurse goes into the home there’s a very personal bond, particularly on a long study when the nurse is visiting over long periods of time,” said Norris. “The person ends up complying and staying in the study because of the relationship with the nurse.”
Clinical Resource Network subcontracts with about 250 accredited home-health agencies in the U.S., Canada, U.K. (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, said Norris.
Other companies that offer such services include U.K.-based Clinical Development and Support Services, a home-care agency with a research component, and Coram, which is primarily a home-infusion services and specialty pharmacy distribution company.
Sponsors are slowly catching on to the merits of going directly to patients. Norris said when the business began, sponsors contacted her when a study’s recruitment and/or retention was going terribly and needed rescue. Now, she said, they understand up front that some populations are better reached in their homes and budget for that.
One driving factor is the increasing complexity of protocols, said Norris. “The FDA is requiring more defined studies on more defined populations. If that’s the hurdle you have to get over to get to market, you make sure you do what you can.”
Another factor driving the business, said Norris, is a greater emphasis on the patient experience. “One of the big trends we’re seeing is a focus on the patient—giving the patient what makes it easiest and most comfortable for him or her to participate.”