Welcome to Bio·IT World's Strategic Insights report on streamlining clinical trials with IT. These stories from leading subject experts illustrate the challenges that pharmaceutical and biotech companies face integrating IT in the final — and perhaps most problematic — step in drug development. They also reveal the dangers to sponsor companies that fail to fully leverage the "e-clinical" opportunity. It's easy to point fingers at the FDA for last year's threefold jump in total review time for priority drugs — now a median of 19.1 months. The FDA has vowed to fix this, but as Colin Spink and Sven Blumenstiel make clear in their story, even a return to median review times of six months won't relieve the drug industry of larger productivity pressures.
The clock is ticking on U.S. patent protection for dozens of blockbuster drugs, while genomic and proteomic research continues to guide the industry toward individualized or targeted-treatment therapies. Companies must get more new drugs into and through trials faster, so the trials themselves need to become more adaptive and data-driven.
Kenneth Getz's lead story brings good news on this front, listing a range of new technologies offered for every area of clinical trials. Dawn Stover reports on the Web's contributions to widening one of the worst trial bottlenecks: patient recruitment. Yet Stover and Getz are careful to identify the many barriers to rapid and widespread adoption.
All things e-clinical will remain vitally important to Bio·IT World readers. Which is why Bio·IT World is expanding its knowledge contributions in this area, from regular coverage to a new online newsletter, eClinica, and from an online Buyer's Guide to our Best Practices awards program, which recognizes the most innovative technology-enabled achievements in drug discovery, development, and clinical trials. We look forward to becoming an essential source for your e-clinical information.
Tony Strattner
Special Projects Editor