BRIC Countries Contribute to Research Contract research organizations (CROs) are working closely with pharmaceutical companies to determine where to conduct global clinical development programs. Market growth, greater regulatory requirements, increased cost pressures, and significant patient recruitment and site selection challenges have led pharmaceutical companies and CROs to make larger investments in four countries: Brazil, Russia, India, and China (BRIC). The BRIC countries, comprise more than 40 percent of the global population. China is now the world's third-largest pharmaceutical market, and from 2006-2009, Brazil, Russia, and India had more industry sponsored Phase II-IV trials than any other emerging country. Each of these countries represents a shift in global economic expansion away from developed countries to countries with newly advancing economies. As biopharmaceutical companies continue to expand their drug discovery, development, and commercial programs, BRIC countries will continue to be given consideration as potential areas to conduct global trials.
Journal: Applied Clinical Trials, Nov 1, 2011
eClinical: A Yellow Brick Road?
123 Next >> When my daughters were younger, we must have watched The Wizard of Oz together a hundred times. We never failed to be disappointed when despite all the bold words of the wizard, a look behind the curtain revealed something much less than impressive. Is the same true as we look at eClinical--bold claims, lots of talk, but little substance in reality when you drill deeper? In this article, I examine some of the success stories showing how eClinical is defining new processes and ways of working: creating a yellow brick road and not simply paving the cow path. Industry technology trends As is the pharmaceutical industry, the supporting technology vendor space is undergoing huge changes. The market is consolidating with vendors extending the breadth of their offerings through acquisition or organic growth. We are observing acceleration in the pace and scale of this consolidation including the large-scale acquisition that brought RTSM (randomization and trial supply management), EDC (electronic data capture), and safety offerings to be added to one corporation's CTMS (clinical trial management system) solution. In another example, an EDC provider has been building RTSM functionality within their EDC solution, while acquiring a CTMS product to broaden their suite, essentially blending internal growth and acquisition strategies. The likely outcome is a marketplace dominated by a number of large suite providers. Each provider is working to make their collection of applications into a coherent and compelling product suite, but also ensuring their framework standards enable the inclusion of other third-party systems within their environment.
Less than 15 years ago the CPMP released a points-to-consider memorandum describing steps to be taken to study the ventricular repolarization liability on the 12-lead ECG. Since that time, many steps have been undertaken by regulatory bodies and the industry (ICH S7A, S7B, and ICHE14 Guidance) as a whole to ensure that drugs that make it to market are safe and without ventricular repolarization liabilities as seen on the surface ECG, as evidenced by a prolongation of the QT interval. Despite these key steps on assessment of the risk of cardiac arrhythmias, drugs such as Vioxx and Avandia have shown a propensity for cardiac toxicity outside the risk of torsades de pointes. It is now realized that cardiac safety involves more than just measuring the QT interval on the surface ECG. This article reviews, briefly, the current state of affairs in the area of cardiac safety in the world of drug development.
Journal:
Applied Clinical Trials, Oct 1, 2011
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