Dec 19 2012
AMC Health announced today that it will provide a broad array of telemonitoring services for an innovative clinical trial that has just been cleared by the U.S. Food and Drug Administration (FDA). AMC Health's telemonitoring technologies will dramatically reduce the cost of this study.
The FDA granted Investigational New Drug (IND) status to a proposal by Transparency Life Sciences (TLS), the world's first drug development company based on open innovation, to conduct a Phase 2a study of the effects of a widely used blood pressure drug, lisinopril, in patients who suffer from multiple sclerosis (MS). Partnering with TLS, AMC Health will provide an array of telemonitoring technologies that will enable researchers to collect data on blood pressure and heart rate, mobility, physical and mental function, symptoms, side effects, quality of life and medication adherence, directly from patients in their homes, eliminating the need for frequent visits to a study site.
"FDA approval of this innovative study design is a significant milestone. Pharmaceutical companies have been worried that the FDA would not accept telemonitoring in place of costly clinic visits," explained John Holland, senior vice president for research and business development at AMC Health. In this 12-month study, patients will see clinical trial personnel twice. Between those visits, all other study data will be collected from patients' homes. Secure mobile video visits will enable researchers and patients to see and talk with one another during the trial.
Holland continued, "This will increase the quality and quantity of data, and reduce the burden on patients. Frequent data collection at home is also expected to increase patient safety, because if a side effect were to appear, researchers will know about it sooner, without having to wait for the next study visit."
While lisinopril is best known as a safe and effective medication for hypertension, pre-clinical studies in animals at the Stanford Medical School Laboratory of Lawrence Steinman, M.D., a world-renowned MS expert, showed that lisinopril may have potential to help reduce MS symptoms and slow the course of the disease.
This Phase 2a study will help determine whether lisinopril is safe and has promise in the treatment of MS, and it could set the stage for a Phase 3 efficacy trial. Unlike the $5-10 million that a Phase 2a study typically costs, TLS expects to be able to conduct the lisinopril trial for approximately $1.5 million, with the bulk of the savings reflecting the use of AMC Health's telemonitoring resources rather than the usual practice of relying on patient site visits to collect clinical data.
"We see significant long-term value in our partnership with TLS," commented Holland. "TLS's crowd-sourced, transparent approach to the design of clinical trials will unlock the creativity of patients, doctors and research scientists, helping to bring useful drugs to market that might not be developed by traditional methods," Holland said.
AMC Health is also providing telemonitoring services for a Phase 1 study of a new drug conducted by a major pharmaceutical company. For most of its 10-year history, the company has focused on clinical care, developing telemonitoring solutions for accountable care organizations (ACOs), managed care companies and home health agencies. "We have been involved in more than a dozen clinical trials over the last decade," Holland said, "but most of them have been studies to determine the impact of telehealth itself. We have had impressive results," he added, "including a study by the Geisinger Center for Health Research that showed a 44 percent reduction in the risk of 30-day hospital readmissions. We are very excited to be bringing our telemonitoring experience to the drug approval process, because we can cut costs while improving the quality of data, patient safety, and convenience."