It looks like the U.S. Food and Drug Administration is feeling growing pressure to make clinical trial design more flexible. A newly approved Phase 2 clinical trial is the first to use both crowdsourcing and remote monitoring
The regulator has granted New York-based biopharmaceutical startup Transparency Life Sciences a greenlight to study the effectiveness of a blood pressure drug lisinopril in multiple sclerosis patients, after clearing the company’s Investigational New Drug application.
Telemonitoring company AMC Health will work with Transparency Life Science to do remote monitoring for the trial. For the 12-month study, data will be collected from the 180 participants’ homes, using wearable monitors to collect vital signs. Secure video interaction between investigators and trial participants will facilitate communication between them.
In the runup to the FDA’s clearance of the IND, Transparency Life Sciences had obtained insights from patients and and healthcare professionals to strengthen the protocol for the Phase 2 trial, such as primary and secondary endpoints, inclusion and exclusion criteria and remote monitoring strategies.
It’s a significant milestone for the FDA and for the pharmaceutical industry. The study is estimated to cost $1.5 million. Using a more traditional clinical study model, with frequent site visits, the one year study could have cost as much as $5 million, John Holland, senior vice president for research and business development for AMC Health told MedCity News in a phone interview. Another benefit is that it will reduce the geographical limitations of clinical trials.
AMC Health is also working with an unnamed pharmaceutical company in a Phase 1 study. The New York telemonitoring business has worked with pharmaceutical companies before, mostly on pilot studies evaluating the use of telemonitoring for clinical trials. It has also worked with Geisinger Center for Health Research in Danville, Pennsylvania to reduce readmissions by improving post discharge patient follow up.
“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, ” Holland said. “A lot of people are collecting electronic patient-reported outcomes so that’s not unique but I have not seen anyone else doing the biometric, medication adherence monitoring that we are doing.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Telemonitoring is not a perfect system either. Information provided by monitors tracking vital signs can generate false alarms. Scalability is also a problem when you are looking at a clinical trial of thousands of people.
Transparency Life Sciences has been a proponent of telemonitoring as an effective way to carry out clinical trials and ensure data is uniform. In an interview with MedCity News earlier this year, Marc Foster, Transparency’s chief operating officer said: “One of the things you see a lot these days is researcher bias, where a doctor or clinician is taking data in a clinical setting their involvement can bias the results of a clinical trial. If people are at home in their most natural setting, the ability to take their data remotely we think would be more uniform.”
Industry insiders from pharmaceutical companies to health IT companies to patient advocates have been pushing for the FDA to be more innovative in its approach to clinical trials. Pfizer’s attempt to use social media to carry out the tricky job of patient recruitment, marked a critical step in how Big Pharma view alternative approaches to clinical trial design. Pharmaceutical companies have been conducting pilot studies for years to ascertain factors that could impact the accuracy of these studies. The evolution in the sophistication of devices that can monitor vital signs and transmit that data remotely without the patient keying it in makes this kind of clinical trial design more feasible. Proponents argue that they can better track participants’ health than regular site visits.
