ePatients also makes it possible to conduct virtual clinical trials, adds Tim Harris, Ph.D., director of the Advanced Technology Program at SAIC-Frederick. For example, a pharmaceutical company might work with physicians to identify anonymous patients in their electronic database who have tumors with a particular mutation and then compare the effectiveness of various therapies in different patients, either by following their progress or by making relevant clinical trials available.
Biosurveillance is another possible application of eMR data. Because the databases function in near real time, they can be used to trace adverse events as well as to identify off-label uses and track actual use of a given therapeutic. GE Healthcare IT has already used its database to help the Centers for Disease Control to identify patients with symptoms similar to H1N1 and to provide co-morbidities to identify outbreak areas. It also has identified food-borne illness and provided real-time alerting.
The availability of eMR may, eventually, cause researchers and regulators to think differently about clinical trials. “What if we could do a controlled release to 500 patients, monitor their health, and see the effectiveness of new medications, rather than enroll them in traditional Phase III trials?” Dr. Dente asks.
Repurposing existing monitoring technology could results in trials in which the participants use home-based technology such as electronic scales, spirometers, blood pressure monitors, or heart monitors to provide that information nightly, rather than visiting a physician weekly.
“That capability is available now,” he says. GE is talking with pharmaceutical companies and waiting for the right opportunity to put this into practice.
“To keep innovation going, the model for introducing innovation needs to change,” according to Harlan Weisman, M.D., chief science and technology officer for medical devices and diagnostics at Johnson & Johnson, and a member of the board of governors for the Patient-Centered Outcomes Research Institute (PCORI).
As he explains, “The FDA is raising the bar for needed clinical data before granting product approvals,” causing more patients to be studied during longer time frames. “These increasing requirements can discourage development of important new innovations.”
“New technologies such as eMRs and emerging methods for conducting outcomes research with large, real-world databases offer the possibility of an alternative approach, in which pre-approval trials demonstrate an acceptable level of safety and efficacy for a new product, based on the seriousness of the condition and the relative unmet need.”
Eventually, Dr. Dente adds, eMRs may play an active role in adverse event reporting in which events like a change of medicine class prompts the eMR to ask where this is triggered by an adverse event. If so, the eMR may populate the report form, which the physician verifies before sending an electronic report.
But, Mark Hoffman, Ph.D., vp of research solutions at Cerner, notes, “Genomic data is only beginning to be incorporated into formal medical records. It’s an important trend to monitor.”