Manufacturer Aduhelm Biogen created a data network to track the real-world performance of neurological disease drugs after clinical trials.
The Clinical Evidence Research Network (CDRN) aims to gather real-life evidence that will help Biogen, in combination with randomized clinical trials, better characterize the safety and efficacy of drugs for diseases such as Alzheimer’s.
Of course, Aduhelm approved his Alzheimer’s drug at Biogen last year. The company must complete a Phase 4 trial of the drug to demonstrate its efficacy to maintain approval.
Spokeswoman Alison Parks told Fierce Biotech the network will include significant members of the science consortium and aim to employ a diverse population of Medicare beneficiaries. The dataset will also include information from another 100 sites with 45,000 patients.
“The inclusion of these additional centers will ensure that the network reflects the quality of care, including all Alzheimer’s clinics,” said Parks.
The plan – detailed in this week’s article – is part of an effort to use real-world evidence to overcome some of the limitations of clinical trials, Parks said. Although randomized controlled trials are the “gold standard” for determining drug efficacy, they often strive for homogeneity in the patient population to avoid discrepancies due to patient characteristics and disease. This eliminates bias and allows researchers to better study the cause and effect relationships between treatment and health outcomes.
However, that means the findings cannot be generalized to a target patient population, Parks said. For this reason, Biogen seeks real-life information to better understand and appreciate drug performance, particularly for a new drug or class of therapies.
Aduhelm belonged to this category. The therapy was the first to be approved for Alzheimer’s in many years and is facing debates and challenges, including a potential Medicare lockdown that only covers clinical trial participants.
With this truly global and data-driven approach, Biogen could have a better understanding of the effectiveness of its drugs in treating neurological disorders. Real-life studies include larger patient populations that have historically been underrepresented in randomized controlled trials: patients who are racially, racially, or geographically different and patients with other medical conditions or who are taking medications that would leave them excluded from typical clinical research.
Parks said real-life data is a good complement to clinical trial data, which can help better understand the patient journey and the efficacy, safety, and value of a new drug in the context of routine clinical practice.
“Particularly in Alzheimer’s disease, underrepresentation in clinical trials is a problem for the entire industry,” Parks said.
She acknowledged that Biogen has even had a hard time recruiting black and African American participants in the past.
“We recognize that common barriers to clinical trial participation include lack of trust in the health care system, inadequate information on research and participation opportunities, access to sites and specialists and logistical issues, as well as industrial practices of collaborating with large established companies. specialized clinical centers trained, “she said.” These challenges can be partially addressed by generating data in real-life contexts.
Parks also cited consumer technology, broader patient eligibility criteria, the inclusion of community medical centers, greater geographic access, and a reduction in administrative burden as ways to increase enrollment in disadvantaged communities to ensure that studies are fully representative of the population and SA.
According to Parks, who predicts this will open up new opportunities for the pharmaceutical industry for the clinical research services sector, there will only be an increase in the use of real-world evidence.
CROs can play an important role in collecting RWE data. We believe capacity will continue to grow as more people understand its value. r Obtain and use RWE data. “