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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Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction

RA Biosimilar Recruitment

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1

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Customizing Real-World Evidence (RWE) Study Designs: A New Framework Tool That Incorporates Elements of Virtual Study Design

While assisting clients with their clinical development plans, and post-marketing studies, our team is witnessing a trend in designing RWE studies with both traditional and virtual elements. With growing interest in hybrid designs, Covance is exploring how we can help our clients incorporate their study objectives while evaluating a range of alternative options for evidence generation that enable faster, less resource intensive and more patient-centric, study execution.

In this second article in our series of three, learn how we collaborated with RWE professionals to create a unique RWE framework tool that can help your teams with study planning in today’s rapidly evolving environment.

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Using Data Visualization Tools on SEND Datasets: A Graph is Worth a Thousand Data Points

SEND [Standard for Exchange of Nonclinical Data] is more than just a tool SEND test submission with Covance. Photo of binary codeto facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.

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ISO 14155 Update: Key risk management changes for medical device clinical investigations in 2019

Futuristic HexagonsThe third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.

According to the International Organization for Standards (ISO), the updated edition will focus on a more stringent risk management approach across all stages of clinical investigations from pivotal to Post-Market Clinical Follow-up (PMCF). Continue reading

How a No-Deal Brexit Might Affect Medical Device Development: Legal Consequences and Risk Mitigation Strategies

How could a no-deal Brexit affect my medical device lifecycle?

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is Image of Flag of Great Britain Overlapped with United Nations Flagpossible that there could be a “no-deal Brexit” scenario.

The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical devices as companies face harsh penalties for violating EU law if they don’t comply; yet they still need to meet business obligations to stakeholders, clients and patients. The political and legal situation is still evolving, and this uncertainty raises many questions for the device development pathway. Continue reading

Inflammatory Bowel Disease Clinical Studies – Where Do We Go From Here?

Diagram of Human Organs

Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large focus upon the development of new drugs for the treatment of IBD. While this is undoubtedly a welcome fact for patients and their families, the current level of research activity brings logistical challenges when conducting clinical trials. Continue reading

Building Awareness with National Diabetes Month and New T2DM Treatment Guidelines

Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with Type 2 diabetes mellitus (T2DM).

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Progress in Treating Chronic Kidney Disease Patients with Cardiovascular Disease: Kidney Health Initiative Develops Clinical Research Recommendations

Throughout the world, kidney disease is far more common than most people realize. It’s not a stretch to call it a “hidden epidemic,” as the number of people living with kidney disease (850 million) is roughly twice that of those living with diabetes.(1)

The health issue presented by chronic kidney disease (CKD) is magnified by the high prevalence of associated cardiovascular (CV) disease in these patients. Patients with CKD most commonly die from CV events.(2) Also, among patients with CV disease, 30 to 60 percent have kidney disease.(3)

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Challenges in the Diagnosis of NAFLD, NASH and Comorbidities in the Pediatric Population

Nonalcoholic fatty liver disease (NAFLD) is the accumulation of fat or lipids in the liver in NASH NAFLD Blogthe absence of significant alcohol uptake or viral infection. Within NAFLD there is a spectrum of disease ranging from excess storage of fat in the liver (NAFL) to fat plus inflammation (called nonalcoholic steatohepatitis or NASH), to liver fibrosis and cirrhosis, or end stage liver disease with loss of liver function. NASH is the most common cause of liver disease in developed countries, largely due to the increased prevalence of obesity and type 2 diabetes. A percentage of patients with NASH and liver fibrosis will progress to liver failure or hepatocellular carcinoma or liver cancer. In fact, NASH is expected to be the number one cause for liver transplantation in a few years, making it critical to identify high-risk patients early. Continue reading