Wearable tech for trials

NEW YORK—Medidata, a global provider of cloud-based solutions for clinical research in life sciences, has announced a collaboration with Memorial Sloan Kettering Cancer Center (MSK) to expand the use of mobile health (mHealth) technology in oncology treatment.

“In the wake of the President’s Cancer Moonshot [Initiative], there is a renewed urgency to combine the best science with the best technology to deliver better treatments faster,” said Medidata’s president, Glen de Vries. “Success in cancer treatment is measured not just by what it does to the disease, but what it does to the patient’s body and mind. Our collaboration with MSK will bring to bear the very best technology and data analytics to help researchers begin to identify multiple myeloma treatments that best enhance quality as well as quantity of life.”

“Medidata will be deploying mHealth technologies in a multiple myeloma trial run by Memorial Sloan Kettering,” says Kara Dennis, managing director of mHealth at Medidata Solutions. “Subjects enrolled in the trial can opt-in to using devices and Medidata’s electronic patient reported outcomes (ePRO) app if they have a smartphone. We believe that these technologies will help MSK better understand their patients’ quality of life. This trial with MSK provides an opportunity for Medidata to collaborate with leading researchers and investigators to use mHealth technology in an oncology setting, and demonstrate the potential for new insight with data that is comprehensive, accurate and attributable.”

Mobile health tools such as Medidata’s ePRO app and SensorLink are helping to make it possible for a growing list of clients, including MSK, to get real-time feedback from patients as well as objective and subjective data on how they are responding to therapy, according to Dennis. Medidata believes that combining patient-reported outcomes with traditional clinical data in this way will lead to a faster and more informed bench-to-bedside feedback loop.

Medidata and MSK have collaborated before for previous oncology trials. Last year, Medidata and MSK discussed expanding their collaboration into new areas of mobile health and analytics. MSK showed strong interest in better understanding patients’ quality of life, says Dennis, and Medidata’s mHealth solutions will allow MSK to capture and measure patient response to therapy, both objectively and subjectively.

“In general, clinical trial sponsors are intrigued by the opportunity to gather data that is more sensitive, continuous or objective than traditional in-clinic data,” Dennis continues. “We see these technologies being deployed in a range of clinical trial phases, including late-stage (Phase 2 and 3) sub-studies, and increasingly sponsors are initiating dialogue with regulatory agencies to discuss their planned approach, including how they will analyze clinical data and evaluate data quality.”

Dennis tells DDNews that Medidata will support MSK with onsite training throughout the trial, to ensure researchers are prepared to train patients on the devices and apps. “By allowing patients to use their own phones, devices which they are already familiar with, MSK is making it easier for patients to participate and stay enrolled in the trial,” Dennis adds.

Through the collaboration, Medidata and MSK will assess the viability of deploying wearable sensors and mobile technology to evaluate quality of life during cancer treatment. MSK will use activity trackers, mobile apps and Medidata’s cloud technology platform to study patterns of movement in patients being treated for multiple myeloma.

“All cancer patients face health challenges from the disease as well as the side effects of treatment. But the challenges are particularly acute for those who suffer from multiple myeloma, a painful blood cancer that affects the bones,” said Dr. Neha Korde, Assistant Attending for the Myeloma Service, Memorial Sloan Kettering. “We will be able to use mHealth technologies to gauge how patients sleep, how they move and how they feel with greater precision.”

Multiple myeloma patients receiving induction chemotherapy will have the opportunity to be part of the collaborative project. In addition to being able to report quality-of-life measures such as activity level, fatigue and appetite through Medidata’s Patient Cloud ePRO app on their personal smart phones, patients will also be outfitted with a activity tracker, which will produce continuous data that MSK researchers will gather and analyze using Medidata’s cloud-based SensorLink solution. This platform will aggregate and process data in real time throughout the trial, providing insight into patterns of movement and quality of sleep.

Patients will be asked to wear the activity tracker one to seven days prior to treatment to establish a baseline, then continuously for approximately four months over four cycles of the prescribed therapy. Data from the app will then be reviewed by physicians and incorporated into treatment discussions with patients, says Dennis. This data will be uploaded to the Medidata Clinical Cloud regularly, and over the course of the treatment, MSK researchers will use Medidata’s visualization and analytics dashboard to assess patient compliance and data quality, and to identify trends and outliers.

“We are uniquely positioned to play a pivotal role in helping make this aspiration [Cancer Moonshot] a reality,” says Tarek Sherif, Medidata chairman and CEO. “We believe that our already strong position in the fight against cancer gives us a natural advantage.”