Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.
CorEvitas brings Thermo Fisher Scientific registries that gather data about how approved therapies are working in the real world. The acquisition will complement PPD, the contract research organization that Thermo Fisher purchased in 2021.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
FDA's draft guidances on real-world data do not provide strict requirements for industry stakeholders to abide by, but they offer patient advocacy organizations with a clearer understanding of how to model their registries to have a more substantial impact for their patient communities.
Miruna Sasu, CEO of RWE company COTA, explained that studies have shown meaningful improvements in efficiency if RWE is used in drug development and that translates into real savings. However, will such efforts continue amidst the ongoing belt-tightening in a tough economy?
In a recent interview, Jennifer Cubino, COO of BC Platforms, discussed regulatory differences between the U.S., the European Union and other countries amid ongoing efforts to encourage patients who want to share their data.
In announcing plans to offer Covid-19 booster shots, the U.S. Department of Health and Human Services cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said the science is less than clear about booster shots, adding that it’s ethically wrong to give third shots when so many around the world are waiting for their first one.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
In the eight months since the Gilead Sciences antiviral drug remdesivir became the first FDA-approved treatment for Covid-19, the company has been collecting real-world data about drug’s effect. The data continue to show that the drug reduces the risk of death and helps patients get discharged from the hospital sooner.
The startup will work with the FDA to evaluate the efficacy and safety of current cancer treatments in different groups of cancer patients.
Can an industry coalition help craft policy to support the use of Real-World Evidence? Five prominent real-world data and analytics companies are betting on it, launching the RWE Alliance.
Evidation, launched as a research app where people can opt into virtual clinical trials, now plans to offer digital health programs. The company recently raised $153 million in new funding.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
The companies will use a combination of more than seven years of medical record data with five years of prospective data on 5,000 MS patients, including real-world outcomes data and MRI images. Other disease areas to be explored include hematology and rare diseases.
The two plan to identify and analyze sources of real-world data that they can use to characterize populations of patients with Covid-19, their use of medicines, risk factors and to characterize potential interventions.
The health technology assessment group and the New York-based company announced their partnership Monday. ICER also plans to use RWE in assessing drugs that have accelerated FDA approval.
Aetion's real-world evidence platform will be integrated with Sanofi's real-world data platform called Darwin to gain a better understanding of the safety, efficacy and value of drugs while also boosting RWE as complementary to clinical trial data in the decision-making process for drug approvals.
The researchers wrote that RWE could complement trials, but that observational methods are unlikely to take away the need for traditional clinical studies.