Remote Clinical Trials
Novartis, the global pharmaceutical giant, has entered into an additional strategic alliance with Science 37, a leader in decentralized clinical trial design and technology, to launch as many as 10 new clinical trials during the next three years. The companies believe that decentralized clinical trials have the potential to increase enterprise around the world, according to an article by Melissa Fassbender in Outsourcing Pharma.
A press release from Novartis said that the agreement adds to its “long-standing investment in and collaboration with Science 37 to use emerging digital technologies to enhance clinical trial participation for patients.” The objective of the virtual trials model is to make clinical studies more accessible, opening up avenues of participation for remote or underserved communities while helping to promote the development of innovative medicines. Studies will combine virtual and traditional models, with accelerating degrees of decentralization, eventually becoming a predominantly “site-less” model.
Novartis was an early investor in Science 37. Together the two companies have initiated virtual trials for cluster headache, acne and nonalcoholic steatohepatitis (NASH).
Decentralized, or virtual, trials use digital technology to enable all or part of a clinical trial to be performed at a participant’s home or local physician’s office, instead of at a central trial site. Expected to begin across the US later this year, the new Novartis decentralized trials will be in the areas of dermatology, neuroscience and oncology.
Science 37’s proprietary Network Oriented Research Assistant (NORA®) technology gives patients an opportunity to participate in studies using mobile devices and telemedicine services. The alliance will apply Science 37’s customized enterprise software to some Novartis’s leading clinical development programs.
According to Rob Kowalski, Novartis’s ad interim Head of Global Drug Development and Chief Medical Officer, “Novartis aims to run studies in ways that overcome many of the barriers patients face when deciding whether or not to enroll in clinical trials, like long journeys or extensive time spent at hospitals or trial sites. With our shared vision of futuristic trials enabled by technology, we’re excited to expand our collaboration with Science 37 to pioneer a new, patient-centric research model.”
Evan Beckman, Head of Translational Medicine at the Novartis Institutes for Biomedical Research, added, “In our experience to date, we have been impressed with the recruitment in the virtual trial setup and believe for many patient populations this will be superior to traditional hospital or clinic sites. Remote participation in research has the benefit of improving the breadth of participation from wider community and socio-economic backgrounds, while also allowing us to gather more meaningful real-world evidence in our clinical trials.”
The Center for Information & Study on Clinical Research Participation (CISCRP) estimated that only 2 percent of the eligible population in the US participates in clinical trials. Participants attend an average of 11 trial site visits in six months, “representing a significant burden for both patients and trial centers.” Bringing the trial to the patient reduces that burden while increasing the reach of leading drug development and clinical trials into under-represented and underserved populations around the world, improving the data for drug discovery and development.
