Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
News, developments and strategies related to eClinical, data management, data collection, ePRO, and more information technology used in the drug development chain. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Name the three biopharmaceutical products that generated more revenue in their first four quarters than Lipitor.
We are guessing that you might have been able to come up with two of them: Celebrex and Vioxx, but the third? Well, the third is Vertex's Incivek for the treatment of Hepatitis C. Incivek generated over $1.5B in sales during its first year. Side note: Lipitor generated "just" $990M in its first 12 months.
The hepatitis C virus (HCV) is a global disease affecting 170-200 million individuals worldwide. It is also the most common chronic blood borne infection in the United States, affecting 3.2-4.0 million individuals. If you have been keeping up with the world of hepatitis C, then you have been on quite a rollercoaster ride over the past several months. The press is riddled with a wide variety of news stories. One of the most interesting new stories is courtesy of the CDC. On the eve of the first ever National Hepatitis Testing Day (May 19), the Centers for Disease Control and Prevention issued draft guidelines proposing that all U.S. baby boomers get a one-time test for the hepatitis C virus. One in 30 baby boomers – the generation born from 1945 through 1965 – has been infected with hepatitis C, and most don’t know it.
So, needless to say, many biopharmaceutical companies are actively participating in the Hep C clinical development space. ISR’s latest report “Hepatitis C: Social Media, Search, and Market Analysis” looks at, among other things, the clinical trial environment and study metrics surrounding Hep C clinical trials. The following illustrates the distribution of the ongoing, industry-sponsored Hep C clinical studies registered in clinicaltrials.gov.
An interesting point from the research shows the current trials in Phase II have considerably more patients per trial than those trials that were completed over the past two years.
Average number of patients per Phase II trial
From a social media and internet search perspective, people who are looking for information on Hep C follow a highly correlated and defined search process. Analysis of this search process uncovers “eLocations” drug companies or advocacy groups can use to better promote Hep C information. A preview of the report can be downloaded from ISR’s website at: http://www.isrreports.com/industry-reports/hep-c-social-media-search-and-market-analysis