November 2003 – The CenterWatch Monthly : PDF
Are Industry Trials Safer?
Biopharmaceutical companies receive most of the negative attention associated with research risk, but government-funded studies pose considerable subject protection risks due to poor monitoring, under-reporting of adverse events (AEs) and failure to compensate for participation-related harm. Due in large part to media exposure and the threat of research suspension, academic institutions have been giving human subject protection much higher priority and AE reporting for government-funded research is improving. The FDA and OHRP are working to align clinical research regulations.
Break-Away Adoption of e-Diaries
Adoption of e-Diaries to collect data from patients in clinical trials is accelerating rapidly—faster than other electronic data capture (EDC) technologies. This is due to several factors including the relative low cost, flexibility and ease with which the solution can be integrated into data management systems, and regulatory support. Major e-diary vendors have raised an estimated $70 million in venture capital and are projecting growth in top line 2003 revenue by 70% to 80% above last year’s levels.
Also in this issue:
- The Changing Role of the EMEA
- Eye on: Asthma and Allergy