By Ann Neuer
July 13, 2011 | CHICAGO—This year’s annual DIA meeting* featured hundreds of exhibitors and session topics ranging from patient recruitment to cloud computing to improving regulatory reporting. There were several overriding themes including the continuing march towards e-clinical suites, the changing requirements for safety reporting, and an increased emphasis on strategic partnering.
Three companies in particular stood out to this reporter: ProtonMedia, DecisionView, and Drug Safety Alliance.
Avatars in the ProtoSphere
ProtonMedia is the Pennsylvania-based developer of ProtoSphere, a 3-D virtual collaboration environment for the high-performance workplace that has had success in the financial services and oil and gas industries. In ProtoSphere, a 3-D avatar is created for each member of a clinical team, enabling them to interact in a virtual conference room and hold face-to-face discussions. Text chat, voice over Internet protocol (IP), and application-sharing are all enabled, allowing people to connect in a socially relevant manner.
CEO Ron Burns says the power of ProtoSphere is about humanizing interactions. “Collaboration is a human-to-human interaction—not a document-to-document interaction. It’s about a higher level of engagement, a two-way discussion. ProtoSphere puts context around those documents, and makes it easier and more interesting to transfer knowledge.”
ProtonMedia’s research indicates that doctors are willing to do an entire education session in ProtoSphere, instead of relying on conventional web tools and slide presentations. “This results in efficiency gains and lower cost, as travel can be cut,” Burns notes. As reported last year, Merck has successfully used ProtoSphere to conduct a virtual poster session (see, “Drug Discovery in a Virtual Environment,” Bio-IT World, August 2010). All attendees surveyed afterwards said they would participate in another virtual event, while junior scientists said they felt more comfortable conversing with senior colleagues in the ProtoSphere than they would in person.
“This is about collaboration and learning coming together in the clinical space, and allowing individuals to have their voices heard,” says Burns.
Patient Enrollment Benchmarks
Linda Drumright, president and CEO of California-based DecisionView, is committed to solving delays in clinical trial enrollment. “Cycle time is taking longer and costing more, and the biggest chunk of that problem is patient enrollment,” Drumright explains.
Enrollment delays have long been an intractable problem, yet much enrollment planning and analysis proceeds with little access to historical data. What data do exist are often found in homegrown solutions such as Excel spreadsheets. “This is our main competition,” says Drumright. “Those spreadsheets are bursting at the seams and there are no consistencies from study to study or from department to department. There’s little visibility of data and therefore, an inability to set expectations.”
StudyOptimizer, DecisionView’s web-based solution, helps life sciences companies deliver clinical trials on time and on budget by automating four processes: planning, tracking patient enrollment, diagnosing problems, and optimizing enrollment. The solution leverages predictive analytics and data visualizations to help study teams monitor actual and projected enrollment in near real-time. “As actual data come in, our forecasting engine shows where you thought you were going to be, and where you actually are,” Drumright explains, adding that customers need industry benchmarking data to make realistic assumptions for rescuing trials and evaluating new therapeutic areas.
To amass the needed information, DecisionView is creating an aggregated, anonymized dataset based on customer-provided information. The input will then be fed back to customers so they can apply it to different therapeutic areas. Once the dataset becomes robust, users of StudyOptimizer will have access to more granular information for planning and creating rescue strategies. DecisionView expects to have the first group of benchmarks available to Roche, Merck, and GlaxoSmithKline this summer, folding that information into a newly released version of StudyOptimizer later in the year. Several desired benchmarks have been identified, such as screening and randomization rates, recruitment cycle time, and drop out percentages.
The new version of StudyOptimizer will incorporate the benchmarks into the application, enabling comparisons of these industry benchmarks with a company’s own historical data as users make planning and rescue decisions for their trials. Only those who contribute data will have access to the benchmark information. “We expect to refresh the dataset quarterly as studies complete and as new StudyOptimizer customers contribute their historical trial data,” Drumright says.
Safety and Social Media
Elizabeth Garrard, chief safety officer of Drug Safety Alliance, a North Carolina-based provider of pharmacovigilance and risk management services, sees growing concern among sponsors regarding use of social media. In the age of Facebook and Twitter, there is little guidance from the Food and Drug Administration (FDA) as to what sponsors should do if they become aware of online postings of possible adverse events. “Sponsors want to know how they can harness the power of social media at a time when FDA has given no direction,” Garrard says.
So far, the only agency guidance is a lengthy draft guidance on postmarketing safety reporting dating back to 2001—the pre-Facebook era—which carried but a single paragraph on a sponsor’s responsibility for reporting adverse events (AEs) from information gathered online. It does, however, list four criteria that determine whether something is reportable. There must be an identifiable patient; an identifiable reporter of the AE; a suspect drug or biological product; and a suspected adverse experience or fatal outcome.
Ten years ago, companies could put up carefully crafted informational Web pages, with little or no ability for readers to post personal responses. But with today’s social interactive media, how does a sponsor respond to a tweet or blog post about a possible AE? If a patient posts a note on a company blog such as, “I lost consciousness after taking the drug,” or “I had to be hospitalized,” the sponsor might be unable to investigate without knowing many relevant facts. “This is fraught with all kinds of unknowns. You don’t know if this person is on concomitant meds, what dose he or she took or for how long, or anything else about that person’s medical history. The only thing you do know is that the patient took the drug, but you don’t know how to follow up,” Garrard says.
Pharma wants to engage its customers but it must also consider if they have a regulatory obligation they are not meeting. (Some research suggests that most of the time, the AE is not reportable because it does not meet the four criteria.) To help customers navigate this process, Drug Safety Alliance provides intake and case processing on AEs and the submission of appropriate cases to regulatory agencies. The company also offers global aggregate safety reporting services and handles risk management projects, such as risk maps and risk evaluation and mitigation strategies (REMS) to further refine the risk/benefit profile of products.
A new guidance addressing social media and postmarketing AE reporting is expected from FDA, but the date is not yet known. In the interim, Garrard says she advises customers to work within existing regulatory confines.
*DIA Annual Meeting 2011, Chicago June 19-23, 2011.