By Ann Neuer 

May 27, 2015 | Symphony Clinical Research, based in suburban Chicago, is distinguishing itself as one of the few providers of in-home clinical trial visits. As the clinical trial sector faces perpetual challenges with patient recruitment, retention, and compliance, being able to conduct a study visit in the home tackles some of these intractable issues, and may accelerate enrollment.

“Just getting to the site can be difficult for a lot of people who have mobility problems, lack of transportation, busy work schedules, or multiple demands on their time. More and more patients are insistent that clinical studies fit in with the competing priorities of their lives, which may not include driving to a site. Being able to participate in a clinical trial in one’s own home makes it much easier for someone to decide to enroll and stay in the trial,” says Nicki Norris, CEO of Symphony Clinical Research.

Norris is referring to industry data highlighting how few people participate in clinical trials and how many drop out once they enroll. Research indicates that patient enrollment is low in the United States, with figures ranging from 4% to 16% who either claim to have participated in a clinical trial or know someone who has. Well-documented reasons for low participation include lack of awareness of clinical trials, lack of trust, or fear that they will be too time consuming. Retention figures are just as discouraging. Losing study volunteers can introduce bias and reduce statistical power that affects generalizability, reliability, and validity of study results. While a dropout rate lower than 5% may lead to minimum bias, a loss of 20% can threaten trial validity. This issue was addressed in a 2008 guidance from the Food and Drug Administration, citing removal of clinical trial data from non-random dropouts as greatly distorting effectiveness results.

As proof that Symphony Clinical’s home visit approach can improve retention, the company points to a case study detailing several phase II/III orphan drug trials with 529 enrolled patients and treatment duration lasting up to two years. Of this group, Symphony provided in home clinical trial services to 363 patients (69%). Besides study visits, the trial had frequent blood draws at local labs, making the study more onerous and retention problematic. Via in-home study visits, blood draws could be performed in the home, with only a few needing to take place at local labs for selected visits. As a result, Symphony’s homecare patients had a 3% dropout rate as compared to a 67% rate for patients who visited the site for all visits.

Symphony performs home visits across a range of therapeutic areas, but largely focuses on oncology, rare and orphan conditions, immunology, pediatrics, and central nervous system disorders, such as Alzheimer’s. Norris explains that for any given study, about 30% to 40% of study visits tend to be in the home. “Typically, the patient goes to the site for the first and last visits and those visits where they need to see the principal investigator, have a physical exam, or undergo a test that requires large instrumentation that isn’t mobile, such as an MRI or CAT scan,” she notes.

The company uses nurses who have been trained not only in Good Clinical Practice (GCP), but also have experience with in-home nursing. According to Norris, “We find that if they lack either background, it’s often not a good outcome. If you have a nurse that only knows one but not the other, such as someone trained in clinical trials but not home visits, they quickly learn that taking the study visit into the home requires a different skill set. For example, a nurse who has only worked at the site relies on the supply closet for supplies or is used to support offered by the site. These typically do not exist in the home.”

Since source data are gathered in the home, Symphony has a process in place for sending those data to the site. The home nurse completes an excerpt of the case report form, and then faxes the hardcopy to Symphony where it is proofed, and then sent to the site, where data can be entered electronically. While this step of the process remains largely paper-based, Norris says she sees capturing of electronic source data as the next horizon. “That’s where data collection is going. We work with 9 out of the 10 largest pharma companies, and we’re expecting to see the ongoing transition to electronic source data, especially with the growing emphasis on improving data quality.”

Currently, Symphony Clinical operates on six continents, and sees home visits as playing a key role in boosting patient enrollment and retention by confronting the issue of study convenience in a big way.