Live from DIA: Clinical trial activity on the rise

Our third and final day at DIA is behind us. On Wednesday, we took the time to see what you and your colleagues were discussing on the exhibit floor. The overall mood at the conference seemed to be very positive; despite some uncertainties looming in healthcare reform and changes at the FDA, the industry overall is doing well.

According to Parexel, cutbacks across the biopharma industry haven't hampered trial activity. In fact, clinical trial activity was up in 2008. In all, pharma kick-started 795 new clinical research programs in 2008, compared with the 662 commenced in 2007. Clinical trial starts for biologics increased by 6 percent. There were 5,700 active INDs in 2008, more than a 20 percent increase over the 4,744 INDs active by the end of 2007.

Parexel also measured trial activity by the number of new FORM FDA 1572--a requirement for all researchers involved in FDA-regulated rials. The FDA registered 23,827 new 1572s from clinical investigators in 2008, up 5.8 percent from the previous year. The number of new 1572s from China-based clinical investigators fell 30 percent due to the long approval process, but signed 1572s from Indian-based investigators rose 14 percent. South Korea investigators submitted 74 percent more 1572s and submissions from Taiwan rose 21 percent. Clinical trial activity is also up in Eastern Europe. The FDA saw significant increases from Russian investigators (20 percent), as well as Romanian (44 percent), Polish (17 percent) and Bulgarian (57 percent) researchers.

As companies move into emerging markets, these local investigators will be key to ensuring adequate knowledge of the trial area's medical facilities and practices, logistics, comparison drugs and regulatory challenges. Choosing a trial site with a similar healthcare system and medical standards as the U.S. system will also be very important, explained Albert Liou, vice president and general manager of Parexel's Asia/Pacific arm.

As for discussion on the show floor, clinical trial solutions providers are focused on integration, interoperability and usability. Providers are working hard to move away from "closed" "legacy technology," as Syed put it, which don't provide a good return on investment to open software that can be more easily managed and navigated by the sponsor and partner.

And for those who have managed to keep up with what drugmakers and researchers are looking for, business is booming--and expanding. According to NextDoc's Zik Syed, the company grew over 300 percent and is on pace to do even better this year, with global expansion. Virtify's Stephen Bergson, executive vice president of commercial operations, also said the data management company is putting more resources into marketing and sales and expects to increase its headcount by 20 percent.

Meanwhile, Peter Benton, CEO of eclinical services provider BioClinica, said the firm has plenty of cash on hand and is keeping its eyes open for prospective acquisitions. Data management solutions provider Phase Forward has not been impacted by the economic climate and exceeded its first quarter guidance, said Martin Young, vice president of corporate development and marketing.

 For more on new products and announcements from vendors, visit FierceBiotech IT.

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