(This is part 3 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.View the complete series in our Inflammation eBook.)
Patient-reported outcomes, compliance and retention are key components of success.
Recent research contends some underlying immune system response mechanisms are common to inflammation-related diseases, such as asthma, COPD, psoriasis, rheumatoid arthritis, lupus and inflammatory bowel disease. These diseases are referred to as Immune-Mediated Inflammatory Disorders (IMIDs). There is a significant shift in the approach to managing traditional inflammatory diseases from organ-based symptom relief to tackling common underlying pathways of immune dysregulation which offers the hope of disease modification. Continue reading
(This is part 1 of a 3-part series on Inflammatory Disorders Studies. View part 2 here.View the complete series in our Inflammation eBook.)
Placebo response rates can obscure treatment effects, putting effective drugs at risk
One of the confounding factors in clinical studies that can contribute to difficulty in discriminating an active treatment effect versus placebo is subject eligibility creep when subjects (e.g. with milder forms of disease severity at baseline) may get enrolled inappropriately by sites when struggling to meet recruitment targets and timelines. Baselines are skewed and misrepresented since subjects initially may be assessed as suffering from the more severe disease grades required to meet inclusion criteria. Continue reading
Image used with permission – Bio-Rad Laboratories and the University of Washington
Simply meeting regulatory standards is not enough for you to remain competitive in today’s evolving immune-mediated inflammatory disease (IMID) drug market. When it comes to FDA approval and successful commercialization of IMID drugs, the consistency of your data is critical. In addition, biopharmaceutical companies such as yours need the ability to detect and quantify small effects, secondary results, potential additional indications, and other insights that can enhance the value of your products.
Covance Central Laboratory Services (Covance CLS) offers extensive in-house capabilities and dedicated support for a variety of key assays used in IMID trials to ensure you obtain unmatched data consistency. One such assay that we perform in-house is the Anti-Nuclear Antibody Indirect Fluorescence Assay, or ANA-IFA – a sensitive screening test used to detect autoimmune diseases. Continue reading
Incorporating technologies such as biomarkers into the development of inflammation therapies can improve the development and delivery of the right therapy, at the right dose, to the right patient. Nonetheless, there are numerous risk factors inherent in inflammation studies and drug development overall. It’s crucial to identify these risks early on in your development plan and develop mitigation strategies that will help decrease your chances for failure. Continue reading
Covance recently hosted a webinar “Best Practices and Solutions in the New Inflammation Paradigm,” where two Covance experts (Global Therapeutic Area Head for Inflammation Dr. Michael George and Executive Director of Operational Strategy and Planning Joan Meyer, Ph.D.) explored a profound shift in the perception and treatment of inflammation and its transformative impact on drug development and clinical trials.
Recent years have seen significant advances in the medical and scientific community’s knowledge of immunology and the pivotal role inflammation plays in disease, providing multiple new targets for anti-inflammatory therapy. A leading area of interest and activity, the global inflammatory therapeutics market is currently estimated at $55 billion per year and growing. Continue reading