Over the past decade, virtual clinical trials (also known as “siteless”, “direct-to-patient” or “remote” trials) have grown in both popularity and usage across the industry. Whereas many in the industry highlighted these types of studies as the future of clinical research for years, we have only recently seen progress in practically defining and conducting virtual studies. These trials use new technologies like wearables, mobile apps, videoconferencing and other tools to ease the burden for both the sponsor and study participants.
Last year, the Food & Drug Administration (FDA) included virtual trials in its draft guidance on increasing patient diversity in clinical research. We’ve long understood the need to create a more inclusive strategy for underserved populations like minorities, women, the elderly population and those who are socioeconomically disadvantaged. A key part of the FDA’s guidance is to work to reduce the amount of site visits required for a trial, urging stakeholders to re-evaluate these visits both at the individual protocol level, and throughout the industry as a whole. The guidance suggests we need to leverage new technology to design better trials, reaching new patients to foster a more inclusive environment (which in turn will lead to better data and higher quality trials).
With these new developments and increased focus on virtual trials, traditional sites may face uncertainty about their future in the clinical research landscape. Even with significant progress made in virtual trial technology over the past decade, research sites continue to play a vital role in clinical research moving forward.
Site Specialization and Resources
On the surface, the need for clinical resources throughout a study is clear. Whether a visit requires a simple blood draw or complex diagnostic imaging, there will always be a need for the specialized, highly controlled care and equipment provided in a clinical setting. In addition to clinical expertise, research sites often have rigorous processes to ensure quality control of data associated with the trial.
Beyond that, regulatory hurdles can still inhibit virtual trials as the FDA works to ensure patient privacy and protection. Concerns regarding data collection and the potential risk of patient data disclosure increase within virtual trials. Sites have specialized teams focused on maintaining compliance and protecting research participants, leveraging processes and expertise built over decades within the industry.
Balancing Recruitment and Diversity
As stated above, virtual trials have the potential to target patient populations otherwise unreachable. However, many of the recruitment methods used to inform these populations fail to have the impact of a personal conversation with a physician. As Craig Lipset, worldwide head of clinical innovation at Pfizer, noted in 2012, “If healthcare providers and treating physicians are the right channel to help me find patients with severe disease, how do I make this trial model fit with that knowledge? Rather than relying completely on the Internet and social media to find patients, can we reach them through the treating physicians?”.
While almost eight years have passed since those comments, many of the challenges around using web- and social media-based recruitment methods persist. Clinical research sites and their affiliated health systems will continue to be a valuable recruitment channel and a vital part of the clinical trial landscape.
A Colossal Shift
Pharmaceutical spending recently surpassed $1 trillion globally, with the clinical trial market expected to reach almost $70 billion by 2026. As this already enormous industry continues to grow, it likely will continue to be slow to adapt new concepts like virtual trials. As noted by Josh Rose, VP of clinical development strategy and innovation and global head of virtual trial operations at IQVIA, clinical trials have largely followed the same model for more than 70 years.
While it may be years or decades before virtual trials account for a significant percentage of clinical research overall, sites should prepare to adjust to the shifting research landscape. “Hybrid” or “de-centralized” trials are likely to become more prevalent in the future, with site visits only required when specialized clinical services are needed. Sites should prepare to adapt to this model, and identify and promote differentiators that will ensure they remain a key part of trial workflows.