The beginning of virtual clinical trials is going to be a game-changer. Why they are going to be game-changer? What changes will occur? Know it all here.
Virtual clinical trials will become reality soon.
The majority of clinical trials are conducted at major research institutions or clinics, often based in urban areas. This can create problems of accessibility for many potential patients who live more than two hours from a trial site or who have work and family responsibilities that make it difficult for them to participate. It also creates significant issues in terms of patient diversity. But, virtual clinical trials can omit these hindrances and make the process more efficient and smooth.
In early June, the U.S. Food and Drug Administration (FDA) issued a draft guidance on improving the diversity of patient populations in clinical trials. The biggest focus is on getting sponsor companies to include more historically underserved populations in clinical trials, including women, the elderly and minorities. The 18-page guidance makes numerous recommendations, including enrichment, inclusive trial practices and design, and methodological ways to bring in a wider range of patient populations.
One of the first recommendations under “Make Trial Participation Less Burdensome for Participants,” is to take into consideration recruitment challenges that might be caused by a planned visit schedule. The guidance states: “Reduce the frequency of study visits to those needed to appropriately monitor safety and efficacy and consider whether flexibility in visit windows is possible and whether electronic communication (e.g., telephone/mobile telephone, secured electronic mail, social media platforms) or mobile technology tools can be used to replace site visits and provide investigators with real-time data.”
How Virtual Clinical Trials Can Become Reality?
Jonathan Cotliar, chief medical officer of Science 37, a technology-enabled virtual trial research company, took time to talk with BioSpace about virtual clinical trials and the role telemedicine, a platform designed specifically to operationalize virtual trials, and biowearables, can play in clinical trials.
“Science 37 was founded almost five years ago by two physician-scientists who understood that clinical trials had a variety of problems—primarily drugs were taking too long to get to the market, were too costly, and once they did get to market the clinical trials didn’t generally represent the taker of those medicines because the trials were plagued by a lack of diversity,” Cotliar said. “Science 37 was founded on the premise that if you make clinical trials more patient-friendly or patient-centric, you could add speed to drugs being delivered to the marketplace and gain access to folks who wanted to participate in clinical trials but were limited by the fact they were too far from the research site or who could not easily leave home.”
Part of what Science 37 offers is a comprehensive platform called NORA (Network Oriented Research Assistant). NORA is designed specifically for virtual clinical trial operations and is loaded on mobile devices to support telemedicine-based clinician-patient interactions.
“NORA allows a lot of these operational considerations to be performed under one roof or platform; point-of-care solutions are embedded, including e-consent, integration with medical devices, biowearables, and video and telemedicine modules that coordinate research activities in the patients’ homes so doctors, nurses or other stakeholders who are geographically dispersed, can interact together,” Cotliar said.
NORA can also integrate with other data clearinghouses like a data warehouse controlled by the sponsor or an electronic medical record at the trial site. It can integrate platforms that include patient-reported outcomes, including e-diaries, which are traditionally migrated from paper to electronic format and can be unified within a single mobile application and/or web-enabled platform.
One reason Science 37 often offers its mobile devices to trial participants, rather than only having developed an app for the iPhone or other smartphones, is that they wanted to make it easier for patients to adopt its use.
“In most cases,” Cotliar said, “we provision that device with a data management plan to truly democratize our participation because we don’t want to stay to participants, ‘Oh, by the way, you have to own an iPhone and a monthly data plan.’ We want to make sure we’re bridging any socioeconomic variable so people who want to participate in clinical research can do so regardless of socioeconomic status.”
They also work to make sure that the company’s methodology and technology model provides patients who have issues with work or family schedules access to clinicians and coordinators on the weekends.
“These are the types of things our virtual clinical trial model addresses, beyond strict eligibility criteria. We talk about these issues for all of our clinical trials, regardless of whether they are taking place in the hospital, clinic or home,” Cotliar said.
Cotliar’s definition of a virtual clinical trial is one where one or all of the patient visits do not happen in the traditional setting, such as a clinic or hospital. Most are performed in the home via telemedicine with some of the visits conducted in the hospital or clinic, and some utilize sensors and biowearables.
Science 37 is currently involved in a number of virtual clinical trials that are presently enrolling patients. They include studies for rosacea, multiple sclerosis, depression, and restless leg syndrome.
The company also has numerous collaborative partnerships with well-known biopharma companies. In January 2019, for example, Science 37 entered a collaborative deal with Boehringer Ingelheim. Science 37 licensed access to NORA for Boehringer Ingelheim’s remote clinical trials. In May 2018, Science 37 signed a deal with UCB in support of clinical trials. Other partners include Eli Lilly, Sanofi, Otsuka and many others.
Cotliar says that every time they discuss a virtual clinical trial opportunity with a sponsor company, there are two overriding questions. The first is, can they maintain patient safety with this model?
“In most cases, we can,” Cotliar said. “Some patients with some diseases have to stay in a hospital or clinic setting, but for many patient populations where it is safe to stay at home, the question is straightforward to answer.”
The second question is, can they maintain the same data integrity as the brick-and-mortar site at the hospital or clinic?”
“That’s not always obvious,” Cotliar said. “In cases where the endpoints are objective ones, such as a blood test, we believe there is no difference whether the collection is occurring at the site or in the home. In cases where the endpoints are more subjective, it often requires further considerations and conversations we have with sponsors and regulatory authorities.”
But technology can reduce travel for both patients and clinical research associates, which should decrease trial costs and increase patient access. And improved patient access should result in greater patient diversity.
The FDA has made clinical trial diversity a priority. Cotliar notes that Science 37 has been in the business for five years. Biopharma executives are often very interested in the opportunities of virtual clinical trials.
“We are finding on-the-ground study teams tend to be more risk-averse, at first,” Cotliar said. “We are earning confidence as the Science 37 team of experts are leading the way in working with sponsors and regulatory bodies to drive awareness of the viability and legitimacy of the virtual trial model.”
Cotliar went on to say, “The progress so far is gratifying, but it’s going to take more time before virtual trials become more common. But we’re getting close to an inflection point.”
