- Means every patient is vital in rare disease, oncology, and immunology research
- Concentrates on every crucial detail of ALL projects
- Results in every trial treated with importance regardless of size
Every patient counts. While large-scale intricately-designed studies can afford to lose patients, clinical trials for rare and complex patient populations are not buffered for atrophy. ARG emphasizes that every patient is vital; in fact, we place the utmost importance on every data point in every study.
We comprehend the importance of timeliness. Given that reaching definitive diagnoses of rare diseases or disorders can be a protracted process, understanding the natural history of such conditions can provide crucial insights into how to reach eligible patients. The same can be said for disease states in oncology and immunology.
ARG thinks about key considerations and asks the right questions. What other specialists should be involved in the care team? Besides the patient and caregiver, which other stakeholders influence study participation? When will the patient be eligible for the trial? Why would the patient be inclined to participate at a certain time? How is the patient’s daily routine going to affect participation?
Narrowly defined projects require attention to detail in recruitment. We look for specific details, such as methods of reaching patients at appropriate points in their journeys. We connect via phone, mail, office visits, patient advocacy groups, and key opinion leaders.
Recruitment for rare disease trials sometimes requires measures that would be considered unorthodox in large indications. While a 1,500-patient Phase III trial for cardiovascular disease can initiate in a high-volume heart center where patients accrue regularly, no “rare disease wards” exist in hospitals. Geographically dispersed patients funnel through many different avenues– including specialists, specialty pharmacy channels, advocacy groups, and care centers. ARG takes all of this into account. And we treat oncology and immunology projects with the same approach.
Once patients are enrolled, we continue to stress communication, providing off-hours coverage, rapid turnaround times, and multiple capture channels, including phone, email and electronic health record portals.
The best way to value every study detail is to focus on specifics. We find out what kind of centrifuge is used, where lab and other needed ancillary services are located, and when and how they can be accessed by research staff conducting protocol-mandated procedures.
We anticipate and address challenges. Patients often must move between offices or lab facilities. The time realistically needed to do so could exceed the intervals for sample collection specified in the protocol, resulting in built-in protocol deviations. We see that possibility in advance through a meticulous protocol review.
ARG currently manages hundreds of clinical trials, but none of them are “just a number” to us. Our President and CEO maintain continual involvement and communication in every one of our projects. Every patient and every detail matters in every study.