Closing the Knowledge Gap with Real-World Evidence (RWE) Studies: The Importance of Starting Early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.

This article discusses the role of RWE, the different information needs among stakeholders and potential solutions for meeting their evolving requirements.

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Real-World Evidence Applied in Real-Life Case Studies

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.

Clinical Trial Data Xcellerate Informatics Covance Blog

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.

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Real World Evidence (RWE) and Market Access in the US

Randomized control trials demonstrate drug safety and efficacy and hence are fundamental for regulatory approval. However, real world data (RWD) becomes a progressively more important source of evidence as we move across the development continuum of a drug. RWD can be potentially useful for obtaining regulatory approval as well. Communicating the value of a health technology is critical for supporting the market access of a drug. Favourable comparative clinical profiles and cost effectiveness can influence the position of a drug in the formulary of a payer.

The 21st Century Cures Act (Section 3037) amended the US FDA Modernization Act 114, directing real world evidence (RWE) utilization to support recommendation of a new indication for an approved drug. This allowed manufacturers to communicate wider scope of a product’s value such as comparative patient reported outcome data. The change broadened the audience covered and helped to expedite market access. The FDA has also acknowledged the importance of RWE for closing evidence gaps while making healthcare decisions. Avelumab was granted accelerated approval due to supportive data from an observational study that described poor outcomes in Merkel Cell carcinoma patients treated by cytotoxic chemotherapies.

Real World Evidence obtained during pre and post phases of drug development provides an opportunity to accelerate market access and facilitate quicker approvals. RWE can be potentially utilized by regulatory authorities to close the evidence gap associated with real-world effectiveness.

[For more on this topic, please listen to our recent RWE strategy webinar on ‘Leveraging Real World Evidence to Drive Patient Access and Affordable Care’. The webinar includes insights from Subject Matter Experts from Roche, Janssen Global Scientific Affairs, and Novo Nordisk as they discuss the challenges facing the industry and share best practices.]

Originally posted on Sciformix, a Covance Company blog

Original Author: Madhur Garg 
Director, Real World Evidence and Market Access

Medical Writing for Patients: An Important Niche

With evolving medical knowledge, there is an ever-increasing need to effectively facilitate knowledge transfer to key target audiences, especially patients and caregivers. Medical writing for patients must not only meet stringent good clinical practice standards and good publication practices but it must also communicate specific information in a clear, relevant and compelling manner. Patient-friendly writing is centered on generating content that engages, instructs and presents medical evidence, which is truly informative and is visually impactful—with use of graphs, figures and images.

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The Biosimilars Landscape: What All Developers Need to Know

As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate Covance Contract Research Org Biosimilars Webinar 2a 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

Maximizing the Value of a Product: A Perspective from China

Drug Development Market Access Covance Shanghai at night, ChinaDrug development in China is progressing quickly, due in part to shifting regulations, increased innovation and growing opportunities for global partnerships. However, making the most of market opportunities requires not only a focus on the intended end results but also careful, early phase planning. At a recent clinical seminar in China, a panel of Covance market access experts shared their thoughts on how to increase a product’s commercial potential.

Incorporating a business case

“In China, we discussed the theme of ‘beginning with the end in mind,’” said Eric Lang, MD, Vice President and Global Head of Clinical Development Leaders, Early Phase Development Solutions. “We find that a lot of biopharmaceuticals are focused more on the science of their treatment and don’t realize that they also need a strong business case to develop a product,” he said. Continue reading

Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

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 Covance Rare Disease Drug Development Market Access Blog. Photo of a man holding a pill. 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.

  1. 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