Product Details

U.S. Sites Rate Novo Nordisk, Novartis and Roche as Top Sponsors in 2007

Results of the CenterWatch 2007 Survey of Investigative Sites in the U.S. have been tabulated. Sites have rated Novo Nordisk the top sponsor to work with. It is the first time the company has ever been rated in the survey. Novartis and Roche were ranked second and third, respectively. Asked in which areas sponsors have generally become better or worse in the last three years, effectiveness of communications with investigators, case report form (CRF) design, medical staff quality, and monitor quality were the top areas showing general improvement. Monitor turnover, feasibility of project timelines, and contract and budget negotiations are the three areas sites said have suffered. Electronic data capture technologies was listed by 43% of sites as most likely to prevent future delays.

Medical Imaging Creating a Special Effect

Medical imaging in clinical trials has gained momentum since the FDA began allowing imaging as part of the evidence in support of a new drug application. The FDA, in an effort to increase new drug approvals, has identified imaging as an important technology for assessing new therapeutics and accelerating drug development in the future. There has been a big increase in demand for imaging services in the past 18 months with players ranging from Parexel to GE Medical Systems ramping up their efforts.

Increasing Interest in Small Population Trials in EU

While distinct definitions exist for orphan drugs and orphan populations, small population studies are more of a gray area, as there is no exact definition of what constitutes one, either in patient numbers or study design. The new European Medicines Agency (EMEA) Guideline on Clinical Trials in Small Populations due to have become operational in February aims to deal with problems associated with limited patient numbers available for study.

Eye On Vaccines

Despite the advent of antibiotics, infectious diseases continue to plague mankind, especially those caused by viruses that do not respond to traditional antibiotics. The likelihood of prevention therefore far outweighs that of cure, mandating development of new vaccines designed to prevent infection with such deadly viral diseases as AIDS, smallpox and hepatitis.

Also in this issue:

• Month in Review
• TrialWatch
• Opportunities Initiating