Celgene partners to develop ResearchKit app for observational study


Clinical trials may be ready to move beyond the late '90s Palm Pilot for recording participant data. At least that’s what Sage Bionetworks hopes. The nonprofit biomedical group is working to create community-based approaches to personalized medicine, and it’s now partnered with Celgene ($CELG) to create an app for use in an observational study.

The iPhone ResearchKit app will aim to better understand the experience of patients living with chronic anemia that’s due to myelodysplastic syndromes (MDS) or beta-thalassemia. The partners will work with patient groups the MDS Foundation and Cooley's Anemia Foundation to best define the necessary elements to capture that are relevant to patients.

Sage previously created an app known as mPower to track Parkinson’s disease patients to collect patient-reported data designed to better understand the burden of the disease.

"We stand at a point where technology is unlocking the ability to capture patient reported outcomes," said Celgene President of Hematology & Oncology Michael Pehl in a statement. "Through our collaboration with Sage Bionetworks and the evolving capability of smartphones and wearables as robust data collection devices, we believe we will be able to provide important new insights for patients with MDS and beta-thalassemia.”

Chronic anemia is difficult to understand and to quantify, so its clinical endpoints have been outside of traditional measures. The study is intended to help move toward routine, multidimensional data collection including on things like physiological testing.

The mobile study will collect neurological assessments of patients using cognitive testing software from BrainBaseline. It will allow two-way communication with care providers about physical functioning and other symptoms.

"We are thrilled to partner with Celgene to explore the use of sensor-based technologies to quantify the daily burden of disease in patients with chronic anemia,” said Sage President Lara Mangravite. “This is a first of its kind exploration from which we hope to gain insights that can be used to understand the impact of chronic anemia."

Celgene has a trio of Phase III clinical candidates in related indications: CC-486 to treat MDS, luspatercept to treat MDS, and enasidenib to treat acute myeloid lymphoma.