An Analytical Approach to Enhance Recruitment of Rheumatoid Arthritis Patients

No single blood test or physical finding alone can confirm the diagnosis of rheumatoid arthritis (RA). However, two tests that detect markers of inflammation are often ordered when RA is suspected: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Other common tests include rheumatoid factor and anti-CCP antibodies.

RA Map

RA patients in the United States

While the test results are clearly valuable to the requesting physician to inform diagnostic decisions, sponsors can also leverage this information to support patient recruitment in an increasingly competitive space. We recently evaluated how de-identified patient data from these common tests run by LabCorp can support sponsors’ clinical trials in rheumatoid arthritis. Continue reading

Central and Eastern Europe Plays Increasingly Leading Role in Clinical Trials

Emerging Markets Case Study

Emerging Markets in Clinical Trials: Romania Delivers Pivotal Boost in Enrollment in Challenging Indication

Intense competition for investigators and patients in traditional clinical research markets has enabled emerging regions such as Central and Eastern Europe, Russia and the former USSR to play an increasingly prominent role in the quest for high-quality clinical trial data. While well-established markets across Western Europe and the U.S. continue to play an important role in clinical research, it has become crucial to leverage the untapped patient and investigator potential of these emerging markets to ensure sufficient and timely enrollment. Continue reading

A Well-Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

A Well Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

The level of investment required and inherent risks in development of today’s new and advanced biopharmaceutical products are greater than ever posed in the history of the industry.  Pharmaceutical products are more specialized, technology is more complex, the regulatory environment more tortuous, global markets for these products are more competitive and return on investment may be uncertain at the early stages of product development.  Additionally, new clinical development tools and regulatory principles, e.g., enrichment strategies, adaptive trial designs, breakthrough designation, are emerging that enable more efficient clinical development, as well as, more expedited approval pathways for new therapeutic approaches to disease management. Continue reading

Identifying Challenges and Proposing Solutions in Conducting Alzheimer’s Disease Clinical Trials

AlzheimersWith Alzheimer’s disease increasing across the globe, the demand for preventative, disease-modifying, and curative treatments is mounting. However, there remain several obstacles, including a high failure rate in Alzheimer’s disease clinical trials.

Given the pressing need for Alzheimer advances, Covance recently surveyed 100 of the most experienced investigators (throughout 25 countries) involved in Alzheimer’s research to gain perspectives that may be critical in planning for successful trials in the future. The majority of investigators included were physicians from large academic institutions, hospitals, and clinics, including neurologists and psychiatrists. Also represented were physicians with a specific focus on Neurogeriatrics, Clinical Pharmacology, and other related specialties. Continue reading

Best Practices and Solutions in the New Inflammation Paradigm

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