Generating evidence by integrating research into patient care
Clinical trials are increasingly using longitudinal evidence generation, where repeated measurements are taken over time from the same set of patients. This is leading to changes in expectations of how research sites carry out trials.
“During the COVID-19 pandemic, we’ve seen therapies reaching the market more quickly in areas such as rare diseases, cancer, and Alzheimer’s disease,” says Brad Hirsch, MD, Head of Product & Implementation at Verily. “Regulatory decisions are increasingly relying on post-marketing data to monitor the safety and efficacy of these new products, boosting demand for longitudinal studies that combine real-world and clinical trial data.”
Hirsch highlights an example where Verily is collaborating with the Duke Clinical Research Institute and Pfizer on the HERO-TOGETHER study to collect real-world data on COVID-19 vaccines for up to two years in 20,000 U.S. healthcare workers, family members, and members of their communities. This includes data about side effects and hospitalizations. The study follows a global Phase III trial involving 44,000 participants at 155 sites; based on the results, the U.S. Food and Drug Administration granted an Emergency Use Authorization to the Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19 in individuals aged 16 and older.
“At Verily, we are driving the integration of research into patient care, reimagining the roles of all stakeholders and the infrastructure we use, and helping to fill the evidence void after Phase I-III studies,” states Hirsch. “Questions remain about how best to use the data generated during care when given consent by a research participant, and how to ensure [the data’s] quality and provenance. There is scope to simplify data entry and move data from the electronic health record into the traditional electronic data capture system. We are optimistic that Verily’s size and scale—including a recent $1 billion investment round to support precision health and our Onduo virtual care model—will enable us to tackle this complexity.”
“We are working to decrease the overall burden involved with clinical trials, helping avoid unnecessary additional procedures and simplifying patient and health system participation, including financial aspects,” says Hirsch. “Integrating research into care simplifies the site’s role, since the majority of study steps involve routine care. This enables study staff to focus on the unique elements of the investigational therapy or study design, such as randomization, creating a simplified way to participate in research. For the participant, the difference between routine care and study participation is incremental – such as wearing a device or completing surveys – rather than involving an entirely separate set of procedures and visits.”
Join Brad at ACRP 2023 [April 28 – May 1; Dallas, TX], where he’ll discuss how this shift to longitudinal evidence will impact clinical research sites, and speak to learnings through case studies from these experiences to help plan for the future. View complete schedule.
“It is vital to empower participants’ voices and data as part of this ecosystem,” adds Hirsch. “In an ideal system, patients would have the opportunity to provide informed consent early within a care infrastructure where they are routinely alerted to relevant trials with a low burden to participate.” Hirsch explains that examples might include completing questionnaires about their experience with a new therapy or wearing a device to capture real-time biometric data. This early consent would enable patients to be engaged longitudinally, with data generated in various ways over time with minimal burden.
“Future progress will depend on a regulatory environment that embraces novel and evolving approaches to trials,” concludes Hirsch. “The key will be understanding the advantages and disadvantages of new designs and matching these to the risk profile of the research, with potential to embrace more innovation in low-risk studies. It appears that regulators are open to considering such approaches.”
Written by Jill Dawson