Embedded sites play a critical role in expanding research into communities, particularly among traditionally underrepresented groups in clinical trials. Lora Parahovnik, PhD, President and Chief Integration Officer of Accel Research Sites (Alcanza’s most recent site member) discusses embedded site strategy, selection criteria for potential partners, and future expansion plans.
1. What is an embedded site, and what role does it play in Alcanza’s operational strategy?
Integrated research establishments are fully resourced clinical research divisions situated within community-based physician practices. Leveraging the identical centralized support services extended to all our facilities, these integrated establishments offer unparalleled connectivity to patients and healthcare practitioners. This embedded framework presents many operational benefits, including seamless access to the targeted patient demographic, the capability to review medical records, the ability to provide in-person education regarding clinical trials, and the access to engage the attending physician in the research conversation.
2. What kind of operational support and resources does the Accel team provide?
All embedded sites receive the same support from our central services as our freestanding research units. This includes electronic regulatory affairs, rapid study start-up, electronic source documentation, internal quality review, advertising, and recruitment services. All standard equipment—locked cabinets, temperature monitoring, refrigerators, centrifuges, whatever is needed—is provided to the site. In addition to the local embedded site leader, nearby regional operational support is always available if needed.
3. Tell us about how the embedded site strategy began, and how it has grown to 14 sites (and counting!)
The embedded site strategy began in 2015, when Carlos Orantes (former Accel CEO and current CEO of Alcanza) started to build relationships with local providers to bring research awareness into the community. These relationships created a strong referral network with local physicians. As physician interest in clinical research increased, the opportunity to bring study conduct even closer to the patients became clear and the embedded site model began. The model has grown steadily over time to meet the needs of physicians and patients alike. Recently, our greatest success has been in specialty therapeutic areas including neurology, dermatology, and pediatric medicine.
4. How do embedded sites support patient education and enhanced patient experiences?
We believe that the best educational outcomes result from in-person interactions. Because the embedded site staff can serve in both a recruitment and coordination capacity, they are equipped to provide education about any part of the clinical research process. Embedded site patients have access to clinical research as a care option, and in many cases have access to these study medications years before the general public. We find that patients with serious conditions want to know they have done everything they can to combat their disease, and this includes clinical trials. Also, the close observation and oversight of participation enhances a patient’s experience, and the overall management of their healthcare.
Most importantly, patients who participate in research through the embedded model can stay with their physician throughout the trial. That’s important for many participants who may not otherwise choose to participate. In most cases, they have built trust through long-term relationships and benefit from having a partner who knows their medical history and can closely monitor trial progress.
5. What are your expansion plans for these embedded sites?
Diversity and inclusivity is an important patient recruitment consideration, so by focusing on community health centers, we can help expand trial reach to different demographic groups. From a therapeutic area perspective, it is our goal to stay aligned with the drug development pipeline. Where possible, we look to invest where the industry demand is especially high, such as pediatrics.
6. What are the criteria you look for in potential partners?
Overall, physicians who wish to engage in clinical research should be dedicated, curious and committed to improving healthcare through medical discovery. We look for these three attributes as initial qualifying criteria when evaluating new potential physician partnerships:
1. Medical Expertise: Specialists for the appropriate therapeutic area or generalists for a variety of therapeutic areas.
2. Time Commitment: Available for training, oversight, and trial conduct to be incorporated into the day-to-day routine of the private practice schedule.
3. Collaborative: Able to work with other providers in the area to support the clinical research participant; for identification of patients, for diagnostic procedures required by the protocol and any necessary consults.
