FDA Oversight Doesn’t Cool Device Market
Post-marketing scrutiny of medical devices by regulators has been ratcheted up following safety questions about drug-coated stents and other medical devices. Contract research organizations (CROs) that have strong experience with post-marketing work and with smaller biotech startups have an advantage in the medical device market.
Should Prisoners Be Allowed to Volunteer for Research?
The use of prisoners as research subjects is one of the most controversial areas of human subjects research, and it has a long, complex history. The Institute of Medicine of the National Academies Report, “Ethical Considerations for Research Involving Prisoners,” urges greater oversight and safeguards in human subjects research involving prisoners. It is important to understand the report’s conclusions in their proper context, not as the last word in the discussion but as the latest chapter in an ongoing ethical debate that will likely continue for some time. Given the recent resurgence of discussion on prisoners as research subjects, the time is right to give the issue a thorough review.
Volterys Offers New Patient Recruitment Model in Europe
Volterys is a volunteer recruitment web site recently launched in France and Belgium. It represents a new patient recruitment model in Western Europe, one that circumvents some of the cultural barriers in Western Europe that prohibit recruiting patients for clinical trials over the Internet.
Eye On Hepatitis C
Hepatitis C, a liver inflammation caused by the hepatitis C virus (HCV), affects nearly 170 million people worldwide, making it the most common chronic blood-borne infection in developed countries. Currently, there is no approved vaccine to prevent hepatitis C. CenterWatch has identified a pipeline of 21 drugs in various stages of development for treatment of hepatitis C. Many of these are antiviral agents or compounds related to interferon.
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