- Novartis and Science 37 commit to launch up to 10 trials with increasing decentralization over three years, scaling to "site-less" model
- Agreement builds on our long-standing investment in and collaboration with Science 37 to use emerging digital technologies to enhance clinical trial participation for patients
- The virtual trials model aims to make studies more accessible, opening up participation for remote or underserved communities while helping advance the development of innovative medicines
Basel, March 7, 2018 Novartis today announced an additional strategic alliance with Science 37, a leader in decentralized clinical trial technology and design, to initiate up to 10 new clinical trials over the next three years. The studies will blend virtual and traditional models, with increasing degrees of decentralization towards a mostly "site-less" model. Novartis was an early investor in Science 37 and together we have already initiated virtual trials for cluster headache, acne and nonalcoholic steatohepatitis (NASH).
Decentralized, or virtual, trials harness digital technology to allow some or all aspects of a clinical trial to be carried out at a participant's home or local physician's office, rather than at a central trial site such as a large hospital. The new Novartis decentralized trials are expected to begin later this year in the United States (US) in the areas of dermatology, neuroscience and oncology, leveraging Science 37's proprietary Network Oriented Research Assistant (NORA®) technology, which enables patients to participate in studies using mobile devices and telemedicine services. Through this alliance, the companies plan to apply Science 37's customized enterprise software to some of the leading clinical development programs of Novartis.
"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," said Rob Kowalski, ad interim Head of Global Drug Development and Chief Medical Officer. "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."
"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," said Evan Beckman, Head of Translational Medicine at the Novartis Institutes for BioMedical Research. "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."
According to the Center for Information & Study on Clinical Research Participation (CISCRP), only 2% of the eligible population in the US participate in clinical trials. Those who do participate attend an average of 11 trial site visits in six months, representing a significant burden for both patients and trial centers. By bringing the trial to the patient, Novartis aims to decrease the burden of clinical trial participation on patients and trial centers. This approach also has the potential to increase the reach of our leading drug development and clinical trials enterprise into under-represented and underserved populations around the world, improving the caliber and quantity of data available to aid in drug discovery and development.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "commit," "builds on," "aims," "vision," "to pioneer," "potential," "will," "plan," "expect," "look forward," "believe," "launch," or similar terms, or by express or implied discussions regarding the strategic alliance with and investment in Science 37, or regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products or the strategic alliance with and investment in Science 37. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the strategic alliance with or investment in Science 37 will achieve any or all of their intended goals and objectives, or be commercially successful. Neither can there be any guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products, and the strategic alliance with and investment in Science 37, could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
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