Parkinson’s Disease Research: Biomarkers May Improve Frequency of Early Diagnosis – Part 1

By Tomislav Babic MD, PhD,

In many neurodegenerative diseases, the search for biomarkers has been driven by an extensive investigation and characterisation of the disease itself, as well as diseased tissue. Due to the examination of post-mortem brain tissue in Parkinson’s disease (PD) research, relevant molecular pathways and genes that have allowed for targeted therapies, development of animal models, and new drug delivery systems have been identified.

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Exploring the Future of Clinical Research for Immune-Mediated Inflammatory Diseases (IMID)

By Ian Braithwaite, Vice President, Global Project Management, IMID Franchise, Global Clinical Operations at Worldwide Clinical Trials and Anna La Noce, M.D., Executive Director, IMID Franchise, Medical & Scientific Affairs at Worldwide Clinical Trials,

  Significant and ongoing research into immune-mediated inflammatory diseases (IMID) such as multiple sclerosis, psoriasis, pulmonary fibrosis and asthma, has led to the knowledge that underpinning these diseases is the dysregulation of the immune system, which leads to widespread and chronic inflammation. Seemingly unrelated inflammatory disorders are now known to share common pathways of immune mediation. While the exact identity of the inflammatory stimulus is often unknown, genetic linkages across indications continue to emerge. These discoveries have delivered a more comprehensive understanding of immune-mediated mechanisms, and the promise for more effective treatments and possibly even cures for a range of IMID diseases. Of course, like other therapeutic areas, IMID studies present a number of unique challenges for researchers including site and patient recruitment, and difficulty in complying with standardized protocols.

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QA Q&A: How Quality Management Systems are Evolving to Support Personalized Medicine

By Margo Holland, Vice President and Global Head of Quality at Worldwide Clinical Trials,

  Drug Safety: the Impact of Personalized Medicine on Clinical Quality Assurance and QMS What do you believe is the most important thing a company performing clinical trials can do in terms of quality assurance ensure the safety and quality of a drug therapy? In my experience, companies such as clinical research organizations (CROs) must be founded on a flexible, proactive, risk-based Quality Management System (QMS) to ensure the proactive identification of important risks, promote data-driven quality deliverables, and facilitate process improvements throughout a drug development life-cycle. All of this supports the delivery of high quality clinical trials, which will bring safe and effective drugs to market in a timely manner. What do you think have been the biggest changes to drug development in recent years? There has been a significant change in the drug development process over the last several years, largely due to personalized medicine which has changed the paradigm of the drug development and drug safety process. Companies are increasingly conducting more complex trials with smaller, focused patient populations that are highly dependent on the identification of biomarkers, and safe and effective diagnostics. This has resulted in regulatory challenges as we try to apply standards that are lagging behind scientific innovation. Phase II Pivotal Trials Increase Need for Post-Marketing Studies Additionally, with breakthrough designations and expedited pathways,...

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Pain intensity rating as an assessment tool at crossroads in the clinic and in clinical research

By Miroslav "Misha" Backonja, Senior Medical Director, Worldwide Clinical Trials,

  Pain intensity rating, most often administered as a numeric pain rating scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable, has been an essential pain assessment tool in clinical research for decades and in everyday clinical practice for more than a decade and a half when it was introduced as a Fifth Vital Sign. In clinical practice, it has been a standard and a mandate that clinicians assess pain as a Fifth Vital Sign and also to intervene with the goal to lessen severe pain in their patients. The wide acceptance of the standard to assess severe pain and to respond with the simplest intervention of prescribing analgesics resulted in overprescribing.

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