OR WAIT null SECS
How can manufacturers ensure their clinical trial methods are evolving along with their product portfolio? It starts by taking a patient-focused approach to trial design, writes Susan Weidner.
As clinical care technology expands and the health care environment rapidly evolves, biopharmaceutical manufacturers are constantly using the latest advances to develop new treatments and therapies to create healthier futures for patients. However, without the ability to test these innovative solutions in a real-world setting, even the most cutting-edge product loses its utility. How can manufacturers ensure their clinical trial methods are evolving along with their product portfolio? It starts by taking a patient-focused approach to trial design.
By using the patient and his or her journey as a starting point, manufacturers can create a more successful clinical trial while avoiding some common barriers. For example, one of the biggest challenges in developing clinical trials is finding qualified patient populations. Understanding where patients primarily receive care and including those locations in trial design benefits both the patient, who no longer needs to change his or her care setting, and the manufacturer, who now has access to a more appropriate patient population.
For many patients, a small, community-based health center is their primary or only point of care. In 2015, 1,375 community health centers provided care to 24.3 million patients, including one in 12 U.S. residents and nearly one in six Medicaid enrollees.1 But, most community-based practices lack the resources and access to make clinical trials available to the patients they serve. Nationwide, less than 3% of patients participate in clinical trials due to the limited number of practices that take part in research. Even practices that engage in clinical trials or other outcomes research may only have one or two studies occurring concurrently, or a limited number of medications available for patients.
For manufacturers and clinical researchers, especially in specialized fields like oncology or urology, accessing the patients who receive care in the community setting is vital. In 2016, approximately 60% of patients nationally receive cancer care primarily in community practices.2 If manufacturers can only access the 40% of patients treated by academic medical centers or larger health systems, it can create significant difficulties in finding appropriate patients. Researchers must consider many patient criteria when designing a study, including patient age, disease attributes, and prior treatment. Lacking insight into more than half of the possible patient population can significantly impact the ability to meet those requirements.
On the other hand, connecting these patients to clinical trials and outcomes research not only helps sponsors, but also providers, who consistently look for the latest therapies to help the communities they serve. With these benefits in mind, IntrinsiQ Specialty Solutions and ION Solutions, both a part of AmerisourceBergen, recently launched AdvanceIQ Network, a network designed to match independent community oncology and urology practices with clinical trials and research opportunities. Through AdvanceIQ Network, these practices have a more streamlined approach to identifying, qualifying for, and enrolling in targeted clinical trials that offer treatment options for improved patient outcomes.
Through the network, practices can select the types of research in which they would like to participate and provide access to key patient information to facilitate patient identification. Clinical researchers can then leverage the AdvanceIQ Network to find practices treating patients who meet specific trial criteria. This offering aims to not only enhance clinical trial matching and capitalize on new innovative trial recruitment solutions, but also increase patient access to the most advanced therapies and treatment strategies. AdvanceIQ Network works to help facilitate clinical trials, investigator research, prospective patient registries, retrospective outcomes research studies, and evidence-based studies. Participating practices and their physicians also receive contract management resources, ongoing research education and training and grant submission support.
Having access to patients receiving care in a community setting is critical for sponsors as they look to test their newest products in the real world. Having a network of community practices gives manufacturers trusted access to additional qualified patient populations, outside of their traditional clinical trial partners, and streamlined enrollment for those patients. It can also give sponsors and clinical researchers the ability to broaden access to a targeted patient population and saves time and resources by finding the right physicians that are treating the population of interest. After the trial is complete, sponsors can continue to track data on the participants to assess the long-term outcomes associated with the drug studied within the trial and in comparison to those in a real world setting.
As specialty care continues to grow, we must challenge ourselves to look for solutions that align multiple stakeholder goals and connect seemingly disparate parts of our health care system. This starts with focusing on the goal that unite us all: creating healthier futures for patients.
Susan Weidner is Senior Vice President, IntrinsiQ Specialty Solutions, a part of AmerisourceBergen.
2IntelliVIEW, 2016. IntrinsiQ Specialty Solutions