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According to Nicki Norris, CEO of Clinical Resource Network, LLC (CRN), the largest challenge to convincing sponsors to use her company’s in-home clinical services is making them aware that this service exists. With its formation almost 10 years ago, CRN introduced its centrally managed homecare services model that provides trained and qualified in-home nurses to conduct protocol visits that are convenient for the patient. The company is well beyond proving its model for regulatory or GCP needs. What is left is spreading the word to sponsors that this model has demonstrated value in helping patient recruitment and retention, addressing challenges arising from inconvenient protocols, transportation barriers, travel/vacation issues and more, and the drive to bring the patient back into the equation of clinical trials.
CRN has numerous case studies in various therapeutic areas, with specific site or subject challenges that demonstrate high return-on-investments. For example, in a Phase II plaque psoriasis study, it required 52 adult subjects at 10 sites to apply the study drug twice a day, in 12-hour intervals. Doesn’t sound too difficult except that the subjects needed to have the morning application applied at the site and the evening dose applied by the subject. Originally, two of the 10 sites enlisted the in-home clinical services to ease the subjects’ burden of getting to the site each morning for 22 consecutive days. Midway through the study, both daily visits were switched to the in-home services model to get better enrollment, compliance and site productivity.
In another example, a Phase IIa, open-label, extension study evaluated the safety, efficacy and tolerability of a drug in an inherited rare disease over a six-month period. It featured an enrollment goal of 32 subjects, with the study drug in capsule form to be taken twice daily with meals.
Because of the rare central nervous system disease, targeted subjects were geographically dispersed, making it difficult for them to travel to the site—of which there was only one in the United States. The study was slow to enroll and, in addition to the travel issue, there were problems with subjects not being available at the visit times required by the protocol.
In this case, in-home clinical services were used for seven of the 11 weekly study visits. During the trial, that single site was able to enroll and retain subjects located in fifteen different states. By using in-home clinical services, they were able to follow one subject on vacation, allowing that subject to be retained in the study. Another subject was able to have some visits in a state where he/she went to school, and some visits in their home state.
Norris sees the increased need for pediatric trials as indicated by both the EMA and FDA as an important driver for the in-home clinical services model, which would help both the caregivers or parents, as well as the pediatric subject feel more comfortable and able to comply with the protocol.
As she explained of the increasing focus on patient-centric clinical trials, which these case studies address, “It is hard to imagine that clinical trials haven’t been focused on the patient the whole time,” said Norris. “But we practically design these trials to be as inconvenient to subjects as we could possibly make them. Developing a study that is convenient and possible for a patient to live their life and participate in a study is definitely the right way to go.”