CenterWatch Monthly February 2010
Second Wave of Sponsor, CRO Growth Hitting Asia-Pac
A second wave of pharma is establishing R&D centers in China and top 10 pharmas are expanding their existing centers, spurring CROs to get busy not only in China but the entire Asia-Pac region.
The decade of Asia-Pac is under way and off to an exciting start as global and regional CROs have made big moves in the region late last year and are planning for enormous growth there.
FDA Guidance Boosts ePRO
The final patient-reported outcome guidance (PRO) from the FDA goes farther than any other FDA document in recognizing the role of interactive voice response (IVR), computer-based patient diaries and other electronic patient-reported outcome technologies.
The guidance recommends how sponsors can use study results measured by PROs to support claims in medical product labeling. PRO vendors have worked under the draft guidance for the past three years, so their products and services should already comply with FDA’s PRO guidance requirements. Many sponsor companies, however, may find they need to provide additional documentation when their new drug applications include PRO data collected electronically.
IQWiG Calls for Mandatory Clinical Trial Transparency in EU
The Institute for Quality and Efficiency in Health Care (IQWiG) recently called upon the German government to push for a regulation to be implemented at the EU level requiring the registration and publication of all clinical trial results to be made mandatory, rather than voluntary.
IQWiG is making the call now because “we have just finished a project in which it became very apparent that our work is affected by publication bias, and therefore we think there is a need for such legal action,” said Dr. Beate Wieseler, deputy head of Drug Assessment, IQWiG.
Eye On: Bipolar Disorder, Depression and Anxiety
Mood disorders are highly prevalent in today’s society. At least 121 million people worldwide suffer from depression, according to the World Health Organization, and in the Western world, 20% of the population will have depression during their lifetime. Among U.S. adults ages 18 to 54, prevalence of all anxiety disorders is more than 16%, according to the U.S. Surgeon General.
Symptoms of depression may include depressed or saddened mood, loss of interest or enjoyment in normally pleasurable activities, changes in weight or appetite, fatigue and sleep problems. In severe cases, patients may have suicidal thoughts and attempts. Depression may occur alone, as in major depressive disorder (MDD), or as part of bipolar disorder, in which periods of depression recur in cyclic fashion.
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