Clinical trials have long played a pivotal role in the advancement of innovation in healthcare. These studies evaluate how medical, surgical and behavioral interventions can impact future patients. A current example of the significance of trials is the development of the COVID-19 vaccine.
According to the Centers for Disease Control and Prevention (CDC), “All COVID-19 vaccines were tested in clinical trials involving tens of thousands of people to make sure they meet safety standards and protect adults of different races, ethnicities, and ages, including adults over the age of 65, participated in the clinical trials.”
The industry can undoubtedly place the production of a vaccine in the win column for the global pandemic, but the adverse effects of COVID-19 have undoubtedly restructured the healthcare industry. Leaders have learned the importance of anticipating the future. Many health systems suffered the consequences of catching up on a decade’s worth of technological advances during this crisis. Digital health has evolved from a novel concept to a must-have.
An article shared by BioSpace, the leading online source for biotechnology news and resources, revealed that several companies prioritized the creation of digital technologies to limit disruption of research progress and keep the highly vulnerable safe. Thus, we’ve seen more clinical trials shift from the traditional setting to virtual platforms.
Benefits of Virtual Clinical Trials
Virtual options can make for more accessibility and, of course, safety. Creating a virtual alternative to clinical trials streamlines the entire experience by leveraging telehealth technologies. While traditional trials can be risky, time-consuming and expensive — primarily due to the cost of hospital or medical center settings — virtual clinical trials create the opportunity to conduct innovative, impactful research that yields effective results.
Below are a few elements that contribute to the value of virtual clinical trials:
- Remote patient monitoring: This is a form of digital health that uses patient-friendly technology to monitor patients at home closely. It can give treating clinicians a more detailed view of patient progress and reduce operational costs. Virtual clinical trials leverage this sophisticated technology to increase patient engagement, enhance study design and streamline the enrollment process.
- Patient safety: Clinical trials operate under strict protocols mandated by the National Institutes of Health and the U.S. Food and Drug Administration (FDA). Trial participants remain anonymous, and all results of the trial are statistically presented as trends. Virtual clinical trials meet patient safety standards thanks to remote patient monitoring solutions offering a built-in level of security. The technology meets electronic medical records standards and HIPAA compliance.
- Artificial intelligence: AI software has found its place in many industries, including healthcare. This technology has the power to bring down costs and even boost the efficiency of virtual clinical trials. The right AI software, for example, can secure eligible patients for complex trials in a matter of minutes rather than months or years.
Tips for Implementing Virtual Clinical Trials
The global pandemic made innovation and technology the top priority in the healthcare industry, and it appears to be a fixture for the foreseeable future. When deciding to implement virtual clinical trials or any digital health advancement, there needs to be a clear understanding of capabilities and plans across the board. This includes:
- Understanding the impact for all involved. Shifting from a traditional setting to a virtual clinical trial affects staff, sponsors and patients, all at varying degrees. Be sure to look at this change from every perspective by identifying the most significant areas of change and conducting journey mapping exercises. For example, a remote site may not mean much to staff, but it could be daunting for a patient who struggles with technology. A robust assessment of these details can help iron out kinks and determine if a virtual clinical trial is the best option.
- Getting familiar with regulatory implications. Leaders should include conversations with health authorities in the planning stages of virtual clinical trials to ensure safety and security during staff operations and document management systems.
- Assessing organizational readiness. Technology is not the only hurdle organizations face when implementing a virtual clinical trial. In many cases, an organization’s dated research and development system can hinder running a trial at scale. A complete dissection of the process from study to design can help an organization identify any needs before transitioning to a virtual platform.
Healthcare organizations have an obligation to strategically stay at the forefront of innovation for longevity and patients’ overall safety. Advancing the industry with virtual clinical trials can create opportunities to achieve this goal with impactful research that yields effective results.
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Sources:
Clinical Leader: 3 Steps to Get A Virtual Clinical Trial Up and Running
Fierce Healthcare: The COVID-19 Pandemic Will Have a Long-Term Impact on Healthcare
National Institute on Aging: What are Clinical Trials and Studies
