AstraZeneca plans to incorporate a mobile app that gathers information about side effects in three clinical trials studying an experimental combination therapy for ovarian cancer.
The app, which was developed by Paris-based Voluntis, seeks to help physicians running the clinical trials to more quickly treat and address two common side effects for these patients: hypertension and diarrhea. The approach may also reduce the time it takes for patients to describe side effects to care teams.
The portal developed by Voluntis, called a companion device, uses a Bluetooth-enabled blood pressure cuff, which gathers data that is sent to a patient’s smartphone and on to the patient’s doctor, according to Voluntis spokesperson Amelie Janson. Patients can also manually enter information about the severity of diarrhea into the app. Both sets of data are then shared with clinicians monitoring the patients in the trial who can then reach out to the patients in order to address the side effects.
The side effects are “easy to manage as long as they identified,” Janson said.
AstraZeneca is testing a combination of Lynparza (olaparib), an ovarian-cancer drug approved by the FDA in December 2014, with cediranib, an experimental therapy, to treat some women with recurring forms of ovarian cancer.
“The support [the app] provides can further reduce medication dose modification and discontinuation rates and help maintain patients on therapy to improve their treatment outcome,” Antoine Yver, AstraZeneca’s head of oncology and global medicines development, said in a news release.
Drugmakers are increasing looking to mobile apps to help improve the patient experience in clinical trials. The data gathered by apps is more accurate than information self-reported by patients and the availability of this data and new data may help reduce the costs associated with R&D. Last week GlaxoSmithKline said it would partner with Propeller Health to use its sensor in clinical studies evaluating GSK’s Ellipta inhaler.
The AstraZeneca trials are expected to begin in early 2016.
Voluntis has previously partnered with other drugmakers, including Roche Diagnostics. It co-developed companion software for Roche’s CoaguChek INR self-testing device, which can be used by patients taking oral anticoagulation therapies. It’s the first time Voluntis has collaborated with AstraZeneca.
There are five clinical trials registered on ClinicalTrials.gov that pair Lynparza and cediranib in the treatment of ovarian cancer. All of the trials are sponsored by the National Cancer Institute and two are currently recruiting participants.
