April 2005 – The CenterWatch Monthly : PDF
CROs: Partners in Drug Safety
Concern about the link between cardiac risk and Cox-2 inhibitors has slowed some clinical trials activity in recent months. Some CROs report a slowdown in activity. However, most industry observers see this as a temporary, which will disappear when new regulations are announced. CROs see not just post-approval work, but the entire drug safety area as an important part of their growth in the medium and long term. CROs already involved in regulatory and safety consulting are investing in staffing and technology to position themselves for a significant role in future safety work.
Site Profits Up; CRO Role Neutral
While Centerwatch estimated site profits were up in 2004 compared with 2002, a number of sites are still reporting shrinking margins. More than half of sites surveyed (54%) in 2004 said their profits were the same when a CRO was involved in managing a study, compared with just 20% in 2002.
Regulators are looking to reform the legislation governing clinical trials of medical devices destined for the European market.
Eye on: GERD
Nearly a fifth of the population experiences heartburn once a week. CenterWatch has identified a pipeline of 12 drugs in development for GERD.