6:44 PM
Mar 09, 2018
 |  BioCentury  |  Product Development

Virtual leap

What Novartis expects to gain from Science 37’s virtual trial platform

Novartis AG’s decision to expand a collaboration with mobile technology and clinical trials management company Science 37 Inc. fits squarely within CEO Vasant Narasimhan’s oft-stated plans to use digital health to speed drug development.

The pharma has already test-driven Science 37’s cloud-based, mobile telemedicine platform within three Phase II clinical trials and has concluded the approach can speed recruitment -- at least in some indications.

Novartis also hopes the platform will identify and enroll more diverse populations than typically participate in clinical trials.

“We want to completely flip the research paradigm and shift to a more patient-centered approach to reduce the burden on patients participating, democratize access for those that are remote and include those patients who are often understudied or represent underserved populations,” said Jacob LaPorte, global head of digital development at Novartis.

“We want to completely flip the research paradigm and shift to a more patient-centered approach.”

Jacob LaPorte, Novartis

On March 7, the partners announced plans to add 10 Phase II and Phase III trials to their collaboration over the next three years in CNS, dermatology and cancer.

“The expectation is that we will be able to broaden this model into more of our portfolio over time,” LaPorte told BioCentury.

Science 37 conducts end-to-end clinical trial processing -- from patient outreach to screening, electronic consent, randomization and data collection -- through its Network Oriented Research Assistant (NORA) platform.

Depending on the indication and target population, the company recruits patients online directly through social media, or via collaborations with patient groups.

Patients who consent to NORA-based trials receive an iPhone loaded with Science 37’s software to monitor and record outcomes in patients’ own homes or at nearby clinics, avoiding the need to travel to research centers.

Patients can use the iPhone to fill out study questionnaires and receive medication reminders. Patients and investigators also can use the iPhones to communicate via text, phone, video or online chat.

Science 37 coordinates with the drug sponsor to ensure that study medication is shipped to patients’ homes. Injectable or infused drugs can be included if home care is provided.

“We really try to operationalize it so that as many elements as possible can stay around the patient in their home or in their local community,” said...

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