Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A publicly-available RWE framework tool was recently released to help enhance collaborative efforts in RWE studies.
Earlier blogs in this series discussed closing the knowledge gap with RWE studies and how Covance and industry professionals worked to develop an RWE framework tool. This third and final blog further explores how the tool was applied in actual case studies to better support RWE efforts in treatments for diabetes and pain management.
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading
Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study and reaching regulatory approval does not necessarily translate to market success.
John D. McDermott, Jr., Vice President of Covance Market Access Services, recently shared his insights on the market access challenges in rare disease drug development and discussed key considerations for sponsors and stakeholders.
Provide early education about the disease
Even though rare diseases as a whole are getting more attention, sponsors cannot assume that their potential payers know much about the particular condition they are targeting and its importance to patients. Continue reading