DIA 2010 proved positive and hopeful.
July 29, 2010 | The 46th Annual Meeting of the Drug Information Association (DIA) held in Washington, D.C. sported a decidedly optimistic tone. Exhibitors claimed to have more traffic at their booths this year, and there seemed to be much less discussion about the economic climate. In its place were a whole host of sessions and exhibits highlighting strategic partnerships among multiple stakeholders, the growing role of payers and comparative effectiveness research, electronic health records, continued globalization, and of course, the latest technological solutions.
Virtify Launches Rules-Based Solution
Sponsors are scrambling to remain in compliance with an ever-increasing array of regulations put forth by regulatory agencies across the globe. In the U.S., for example, complying with Protocol Registration System (PRS), the Web-based data entry method for www.clinicaltrials.gov, requires companies to conform to thousands of rules that define how data on clinical trial postings and results are to be registered and disclosed to the Web site. Virtify, a provider of enterprise content compliance solutions for the life sciences sector, is addressing this tough challenge head-on with its DIA-announced Clinical Trials Registration & Results software solution—CTRR Enterprise 2.0.
“Our new CTRR product has a 5,200 rules engine to keep customers compliant with PRS requirements while helping them mitigate their staffing needs. Companies are anxious to reduce their out-of-compliance status and the cost of adhering to that compliance,” says Stephen Bergson, Executive Vice President, Commercial Operations at Virtify.
According to Bergson, remaining in compliance with constantly changing regulations and deadlines is a highly complex and burdensome endeavor for most companies, especially since rules-based database requirements for clinical trial registries are a global phenomenon. For instance, the European Union (EU) is slated to release Version 8 of the European Clinical Trials Database (EudraCT) and the EU Clinical Trials Register in September 2010. In addition, the European Commission recently released a draft technical guidance that details how result-related information should be uploaded to EudraCT in the future.
Virtify maintains a staff that monitors these sorts of regulatory changes that are happening in many countries. This surveillance allows the company to make updates without having to re-validate the software every time a new rule is established. Bergson explains, “When new rules are put in place, CTRR will be updated promptly and appropriately.”
Enough with the ‘e”!
One of the most insightful discussions at this year’s DIA took place at a breakfast meeting I had with Beth Harper, industry veteran, and Chief Clinical Officer of the newly formed CenterPhase Solutions, a company dedicated to improving clinical trials performance. We got together on the last morning of DIA at the charming Coeur de Lion restaurant in the Park Henley, an 88-year old hotel across the street from the Walter E. Washington Convention Center, this year’s site for the DIA Annual Meeting.
Just as I was about to dig into my cinnamon brioche French toast, Harper announced, “I’m ‘e’-d out. There’s e-clinical, ePRO, eCRF, EDC, but what about people?” Harper asks. “This is a people business. A relationship business. Many investigative sites tell me they miss the days of being able to call a monitor and ask a question. Today, many sites don’t even know who their monitor is for a particular study, and to answer questions, they have to log onto an e-learning portal to look at the study manual.” Harper explains that this might work most of the time, but if the site is attempting to enroll a patient right then, it would be easier to simply pick up the phone to ask a question, but unfortunately, those days are mostly gone.
Significantly, despite, all of the e-improvements, CenterWatch reported in a 2009 study that less than 10% of clinical trials are completed on time. Additional research from CenterWatch indicated that 70% of investigative sites are more than one month behind in enrollment, and only 7% of sites report meeting enrollment timelines.
“E has not solved the root causes of study delay, and it’s not costing any less to go with e-everything. Products today haven’t gotten safer with e-tools, and drugs haven’t become more effective and aren’t coming to market any faster,” Harper points out.
Harper is a specialist in helping sponsors improve investigative site performance and is not anti-technology. In fact, she believes in balance and clearly recognizes the tremendous value of eliminating the mountains of paperwork and documentation that has typified clinical trials for so long. But as she tells it, “technology is no substitute for personal relationships among the many stakeholders. I like interacting with people, and I get exhausted being “blackberried” all the time. When there is a personal relationship, you are more likely to feel a commitment to perform. How can you have a commitment or a sense of obligation to someone you’ve never met? We’re losing the human touch.”