Novartis and Science 37 have announced plans to launch up to 10 new virtual clinical trials over the next three years in an attempt to boost trial participation. The studies will merge virtual and traditional trial models with increasing degrees of decentralisation, moving towards a predominantly ‘siteless’ model.
Virtual, or decentralised, trials allow either aspects or the whole of a trial to be digitised, making use of apps, monitoring devices and online social media platforms to enable patients to participate at home or at a local physician’s office. This can increase a trial’s reach to remote or underserved communities.
"Novartis aims to run studies in ways that overcome many of the barriers patients face when deciding whether or not to enrol in clinical trials, like long journeys or extensive time spent at hospitals or trial sites," said Novartis global head of drug development and chief medical officer Rob Kowalski.
"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."
Novartis’s new virtual trials are due to begin in the US later this year, targeting the fields of dermatology, neuroscience and oncology. They will apply Science 37’s proprietary Network Oriented Research Assistant (NORA) technology, allowing patients to participate using mobile phones and telemedicine services.
"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," Novartis Institutes for BioMedical Research head of translational medicine Evan Beckman said.
"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."
Novartis was an early investor in Science 37, a leading figure in decentralised clinical trial technology and design. Together the companies have already initiated virtual trials for cluster headaches, acne and nonalcoholic steatohepatitis (NASH).
Improving the accessibility and convenience of trials remains a priority for many pharmaceutical companies, which often report trial participants’ waning interest due to convenience issues. A study by the Center for Information and Study on Clinical Research Participation found that in the US 87% of patients expressed a desire to participate in relevant trials, though 70% live more than two hours away from the nearest study centre. The same study found 80% of clinical trials in the US are delayed due to recruitment problems.
An advantage of decentralised trials is that they remove the necessity of numerous visits to designated sites. By improving a trial’s accessibility, Novartis hopes to diminish the burden of clinical trial participation on both patients and trial centres.
Virtual trials also have the potential to reduce risks in the drug development process. Patients can be monitored in real time with remote monitoring devices. Digitising trials would also enable investigators to adapt studies in response to changes and reactions seen in participants. Any dangers in the drug under investigation would be perceived more rapidly, allowing for faster termination of a trial and reducing expenditure on failed studies.
A number of other companies are aiming to expand clinical trial reach through technology. Earlier this month Science 37 announced a partnership with Sanofi, also for the purpose of developing virtual clinical trials. Through mobile and telemedicine technology, Sanofi plans to develop more decentralised, patient-oriented trials.
According to Science 37 such technologies have the potential to reduce the average time required for a trial by at least 30% and as much as two years. This is not Sanofi’s first foray into decentralised trials, having backed a virtual diabetes trial in 2015. The study successfully employed an online platform for all patient-investigator communications and used 3G-enabled wireless blood glucose monitors to collect patient data from home.