Mar 24, 2022 10:15am
Aduhelm maker Biogen has set up a data network to track how neurological disease medicines perform in the real world after clinical trials.
The clinical data research network (CDRN) is designed to gather real-world evidence that, in combination with randomized clinical trials, will help Biogen better characterize the safety and effectiveness of medicines for conditions like Alzheimer’s disease.
Biogen, of course, got its own medicine for Alzheimer’s disease approved last year, Aduhelm. the company must perform a phase 4 trial on the med to prove its efficacy to maintain the approval.
Spokeswoman Alison Parks told Fierce Biotech that the network will include leading members of the scientific consortium and aim to include a diverse population of Medicare recipients. The dataset will also include information from another 100 sites with 45,000 patients.
“The inclusion of these additional centers will ensure the network reflects the standard of care, inclusive of all Alzheimer’s disease clinics,” Parks said.
The plan—which was detailed in a paper this week—is part of an effort to use real-world evidence to overcome some of the limitations of clinical trials, Parks said. While randomized controlled trials are the “gold standard” when trying to determine a drug’s efficacy, they often seek homogeneity of the patient population to avoid variance introduced by patient and disease characteristics. This eliminates bias and allows researchers to better examine cause-effect relationships between a treatment and health outcomes.
But that means the results may not be generalizable to a target patient population, Parks said. That’s why Biogen is turning to real-world evidence for better insights and knowledge on how medicines perform, especially in the case of a novel medicine or new class of therapies.
Aduhelm belonged in that category. The therapy was the first approved for Alzheimer’s in decades and has since been met with debate and challenges, including a potential blockade from Medicare providing coverage only to clinical trial participants.
With this real-world data approach, Biogen may be able to get a better picture of efficacy for its neurological disease medicines. Real-world studies include larger patient populations that are historically underrepresented in randomized controlled trials—patients who are ethnically, racially or geographically diverse and those who have other conditions or are taking concomitant medications that may otherwise exclude them from typical clinical research.
Parks said that real-world data is a nice compliment to clinical trial data that can help provide a better understanding of the patient’s journey, as well as a new drug’s efficacy, safety and value as part of routine clinical practice.
“In Alzheimer’s disease specifically, lack of representation in clinical trials has been a problem for the entire industry,” Parks said.
She admitted that even Biogen has had trouble enrolling Black and African American participants in the past.
“We are aware that common barriers to participating in clinical trials include mistrust of the healthcare system, inadequate information about research and opportunities to participate, access to sites and specialists, and logistical concerns, as well as the industry practice of working with large, well-established, and well-trained clinical specialized centers,” she said. “These challenges can be addressed, in part, by generating data in real-world settings.”
Parks also noted wearable technologies, broader patient eligibility criteria, inclusion of community-based medical centers, wider geographic outreach, and less administrative burden as ways to boost enrollment in underserved communities, to ensure trials are fully representative of the American population.
Drug industry use of real-world evidence is only going to increase, according to Parks, who predicted that this will create opportunities for the clinical research services sector.
“CROs can play an important role in RWE data collection. We believe capacity will continue to grow as more people continue to understand the value of and utilize RWE data.”