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Specialty at-home and alternate-site testing services offer solution for subject recruitment issues.
Subject recruitment and compliance remain a daunting necessity of the clinical trial process, often requiring sponsors to spend excess amounts of time and resources.
Presently, companies designed specifically to address such issues that provide in-home and alternate-site health care services have emerged within the clinical trial industry and are sparking international interest.
These unique services allow investigative sites to have tests conducted at a subject's home rather than require the subject to be on site. "By making study participation more convenient, more patients are more willing to participate," said Gail Adinamis, founder and chief executive officer of Clinical Resource Network (CRN), a leading provider of these services that's based in Deerfield, IL.
Case Studies: CRN Services Effect on Subject Compliance and Trial Timelines
Now, after proving successful in the United States, CRN is expanding into the international research market. Adinamis explained to Applied Clinical Trials that the initial plan was to expand only within the United States, but because of increasing proposals from foreign countries, the expansion plan was altered to include the international market.
Though it had already done business in Canada and the UK, within the last year, CRN's services have reached over 20 new countries, most of which are located in Europe. "There's a popular demand for our services on a global basis; six out of nine are global requested services," Adinamis said.
When deciding which countries to establish its services in, Adinamis said, "we look at it from a variety of attributes, including clearly defined regulations, clinical infrastructure, and even tax perspectives."
Companies around the world are trying services like CRN's because it proposes a solution to one of the biggest challenges in clinical trial studies. Adinamis explained that "once the ideal subjects are enrolled, there is an average 20% to 30% dropout rate."
In an effort to prevent these dropouts from affecting the trial, "designing protocol sponsors will over enroll and have 20% to 30% overage." Taking such precautions can lead to wasted resources, while a lack thereof can result in a lengthened trial, and "over 95% of studies fail to meet the target timeline," Adinamis added.
Gail Adinamis, founder and chief executive officer of the Clinical Resource Network.
Homecare services can become even more critical in trials that focus on subjects with debilitating diseases such as Alzheimer's, or rare diseases. Subjects with "rare diseases, which affect less than 200,000 people, are remotely scattered and they typically have to fly them and their caregiver to the investigative site," Adinamis explained. "The cost to fly is far more expensive and patients having to travel can be challenging."
When sponsors choose to utilize these services, they instruct CRN on what services will be needed on a subject-by-subject basis. Once a specific subject's requirements are clear, CRN reaches out to the appropriate professionals within its network of over 3000 prequalified, licensed, and accredited home health care agencies and over 10,000 individual clinicians.
CRN's program managers are then responsible for training a primary and backup nurse on the GCP and study-specific requirements. The nurses then conduct the services, complete the necessary documents, and forward them to the investigator site.
In order to efficiently integrate its services into the international market, CRN uses "country program managers who are familiar with the local culture, language, and regulations. We did a lot of planning upfront to understand the local requirements, so we're well prepared for specific countries," Adinamis said.
"Our homecare project management services are available 365 days a year, 24/7," Adinamis added. Beyond providing personal homecare services for the individual subject, CRN also offers pharmacy and supply services.
As CRN has sprung full force into the international market within the last year, it has no plans on slowing down. Continuing on its expansion into the international market, Adinamis told Applied Clinical Trials that in the following year, CRN will be developing its services in Australia.
As a result of the tremendous growth it has experienced recently, CRN has been included in the 2000 Inc. 5000 list, INC's list of the fastest-growing privately held companies in the United States. CRN was also recently certified by the Women's Business Enterprise National Council (WBENC).—Marissa Shapiro