Real-world industry round-up: partnership to provide unique insight into the value of autoimmune disease therapies
This month: The US FDA awards a grant to the Critical Path Institute (AZ, USA) to establish a clinical outcome assessment consortium for rare diseases and Vivli (MA, USA) announces it is to establish a data-sharing portal for results from COVID-19 treatment trials.
In this latest installment of our regular monthly column, we summarize a selection of key real-world evidence industry developments that have taken place over the past month.
The news highlights:
Avalere Health and Corrona to provide unique insight into the value of autoimmune disease therapies
Critical Path Institute receives FDA grant to establish Rare Disease Clinical Outcome Assessment Consortium
Data-sharing portal for outcomes from COVID-19 treatment trials to be launched
New registry to collect and share data on how COVID-19 affects individuals with rheumatic diseases
Avalere Health and Corrona to provide unique insight into the value of autoimmune disease therapies
Avalere Health (DC, USA) and Corrona (MA, USA) have announced their partnership aiming to leverage real-world data from both Avalere Health’s parent company’s registry and Corrona’s independent registry, to gain important insight into the real-world value of therapies for autoimmune diseases.
John Linnehan, Director of Avalere Health’s healthcare economics and advanced analytics practice, commented: “Analytics using Avalere’s payer-sourced claims data along with Corrona’s rich clinical data offer a unique view into the value of therapies and services that treat and manage autoimmune diseases. This collaboration will allow for the generation of insights that can support the evaluation of treatment modalities for patients suffering from autoimmune conditions and lead to improvement in patient outcomes.”
Critical Path Institute receives FDA grant to establish Rare Disease Clinical Outcome Assessment Consortium
The US FDA’s Center for Drug Evaluation and Research has awarded a grant to the Critical Path Institute (AZ, USA) to help fund the establishment of a Rare Disease Clinical Outcome Assessment Consortium. The first step in the establishment of the consortium has involved the founding of a Rare Disease Subcommittee within the institute’s existing Patient-Reported Outcome Consortium. The focus of the subcommittee will be on accelerating the development of new medical products intended to safely and effectively treat people with rare diseases.
Representatives serving on the Rare Disease Subcommittee include individuals from the Critical Path Institute itself, grant sub-awardee the National Organization for Rare Disorders (CT, USA), the FDA, the Patient-Centered Outcomes Research Institute (DC, USA), the National Center for Advancing Translational Sciences (MD, USA) and various biopharmaceutical firms working to develop treatments for rare diseases who are already members of the Patient-Reported Outcome Consortium.
Data-sharing portal for outcomes from COVID-19 treatment trials to be launched
Vivli (MA, USA) has announced it is to launch a portal for researchers to openly and freely share data obtained from trials into potential treatments for COVID-19.
Rebecca Li, Executive Director of Vivli, stated: “Today, we are announcing this initiative as it is so important for the entire data-sharing community to come together and do everything we can to share the data from these completed clinical trials. Sharing data transparently and openly is the best way to honor the decisions made by participants in these trials and bring us closer to safe and effective treatments and vaccines.”
New registry to collect and share data on how COVID-19 affects individuals with rheumatic diseases
The newly established COVID-19 Global Rheumatology Alliance has launched a registry to facilitate global sharing of information from medical practitioners on how COVID-19 is impacting patients with rheumatic diseases and how the virus interacts with rheumatic disease-associated comorbidities and medications.
“The motivation to get this started was the fact that we didn’t have any information to tell our patients, or to tell our colleagues, about how to manage the patients who were at risk of infection,” explained Philip Robinson (Royal Brisbane Hospital; Queensland, Australia), Chair of the Alliance.
Paul Sufka, a Rheumatologist at HealthPartners Medical Group and Regions Hospital (both MN, USA), commented: “Ultimately, we felt that building a worldwide registry was the best way to contribute reliable, evidence-based information and resources desperately needed in these rapidly evolving discussions.”