By Ryan Jones, CEO, Florence Healthcare
The COVID-19 crisis brought lockdowns and travel restrictions, remote work and virtual learning, illness and loss. While the pandemic ushered in many hardships, we can and should look at the vaccine development process as one source of hope in an otherwise dim year for the global community.
The crisis drove pharmaceutical companies to complete trials in record-breaking time. In December 2020, just nine months after lockdowns began, the FDA granted emergency use authorization to vaccines developed by Pfizer and Moderna. Two months later, the Janssen/J&J vaccine was authorized as well. As of mid-June 2021, nearly 146 million people, or 44% of the total U.S. population, have been fully vaccinated. This is indeed light speed compared with the historic seven-year vaccine development timeline.
But while many people view these vaccines as long-awaited solutions, some are wary of the speed of their development.
Until now, vaccine development and approval in less than a year was unheard of. So, how can we be sure the vaccines are safe? Greater understanding of the COVID-19 vaccine development process can mitigate safety fears and illuminate opportunities for technology vendors to support improved drug development in the future.
Going from 50 to 100, Not 0 to 100
In an interview on “The Next Phase” podcast, executive vice president of Maxis Medical, Suji Shetty, explained the public misconception that the COVID-19 vaccine development process went “from 0 to 100.” Shetty instead argued that it went from “50 to 100.”
Researchers have been studying the mRNA technology that forms the base of Moderna and Pfizer’s solutions for years, long before the pandemic. COVID-19 demanded that this research be executed on a larger scale.
Further, high infection rates of COVID-19 led to greater study enrollment. A process that normally takes years was cut to a few months as pharma companies secured the case requirements to conduct trials. These elements helped to expedite the studies’ results and final approvals. In a very positive sense, it was a perfect strom to accelerate research and approval timelines in a safe way.
Innovative Technologies are Key to Accelerated Drug Development
The COVID-19 trials were not accelerated just to get faster results. Instead, experts leveraged previous research data, collaborated on supporting technologies, and initiated strategic processes to deliver successful results.
A quick and effective vaccine is great news in the current pandemic, and it bodes well for the future of clinical trials. It is in everyone’s interest to reduce traditional drug development timelines.
Faster timelines support better health outcomes, and the COVID-19 vaccine case study proves that these timelines are possible. Innovative technology solutions, coupled with decentralized trial methods, can support efficiency in clinical operations without compromising patient safety.
There are three factors that the technology industry must address to support future accelerated drug development timelines:
- Solve for the efficiency gap. New clinical studies have grown by 300 percent, while concluded studies have only grown by 50 percent. Innovative technologies, such as remote study start-up, document collaboration platforms, and remote site monitoring tools allow sites, CROs, and sponsors to expedite the tedious processes of clinical trials. Tech can shorten time spent traveling, scanning and processing documents, and compiling reports.
In addition, these solutions support greater oversight and real-time monitoring, which delivers speed and ensures greater patient safety. With these tools, research proceeds at an accelerated pace to deliver results for the advancement of human health.
- Support the requirements of precision medicine. Precision medicine has changed the practice of patient selection. The drugs for these trials are more precise, making it difficult to find the right patients to participate. This challenge can be alleviated through increased access to data to ensure patient population fit, and by geographically expanding recruitment to reach a broad array of participants.
Specifically, data and technology integrations in research can strengthen clinical research sites’ patient recruitment efforts by identifying candidates who live beyond the site’s immediate region of focus. These solutions not only widen the patient pool, allowing for faster participant selection, but also allow studies to progress more efficiently. This is how precicion medicine research should work from here on out, and in a way we have the pandemic to thank for this shift.
- Bolster virtualization efforts. Today, clinical trials are restricted by geographic area and patient demographics. Patients in distant or remote areas might struggle to reach the study site, and a lack of patient diversity may skew results. Remote access technologies can make a difference by allowing researchers to interact with and support patients otherwise out of their reach.
Simultaneously, remote technologies expand opportunities to reach diverse and underserved communities. A lack of diversity in clinical studies can impact the safety and efficacy profiles of resulting therapies and cause potentially dangerous inequalities.
Technology can help clinical trials avoid these pitfalls by supporting diversity and inclusion. Wearable health devices and even smartphones can play a critical role in expanding study access and improving patient care.
Key Takeaways about Accelerating Drug Development
It is the technology industry’s responsibility to foster solutions that can solve for the effiency gap in clinical research, support the increasing requirements of precision medicine, and bolster virtualization efforts that increase diversity and inclusion. The pandemic accelerated adoption of these approaches, but if we in the industry keep pushing in this direction, we can expect to see greater efficiencies in clinical operations and, as a result, accelerated development for future, life-saving therapies.
Ryan Jones is CEO of Florence Healthcare. Florence advances clinical research through software—its electronic Investigator Site File (eISF) helps over 10,000 research teams around the world take their day back from paper. Before joining Florence, Ryan was president of Pubget (acquired by the Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals and research institutions worldwide. Ryan joined Pubget from Microsoft’s SharePoint team, where he helped the web’s largest sites make information understandable and accessible with document management technology. Before Microsoft, Ryan analyzed enterprise software investments at Commonwealth Capital Ventures and built technology market strategies at the Yankee Group.