Clinical researchers showed the world what was possible during the COVID-19 pandemic. Those heightened expectations, driven by technology and an emphasis on diversity, have never fallen as the industry faces its future.
That’s the takeaway from clinical research company WCG’s Clinical Research Trends & Insights 2024 report, issued Thursday. The firm’s experts say that the key issues facing clinical research in 2024 include a lack of resources, the demands of implementing multiple technology platforms as well as new technologies like AI and machine learning that have great potential but a steep learning curve.
“The tumultuousness of the ‘pandemic years’ has lessened, giving rise in 2024 to an intense focus on people, timelines and quality in conducting clinical research,” wrote Sandra Smith, senior vice president of clinical solutions and strategic partnerships for WCG.
WCG’s Tyler Bye, director of site solutions and product strategy, said that the entire research ecosystem came together to aid the vaccine effort during the pandemic. The heightened expectations on the potential of vaccine research have not subsided since the immediate danger of COVID-19 passed.
“Our industry, and the world, saw incredible speed and results. Now that the world has progressed and individual factors are no longer aligned, the goal of vaccine research stays the same. Because of this, the next year will see the continued trend of high expectations, with traditional resource constraints in place, bringing the need to focus on enhancing efficiency at sites,” Bye wrote.
Right now, the number of clinical trials being initiated exceeds the number of clinical research sites available to conduct the studies, according to WCG. The time it takes to conduct a study has grown from 14 months in 2020 to 24 in 2023. “Active clinical research sites have become saturated and are facing unrelenting pressure to meet protocol endpoints within the timelines dictated,” the report said.
Sites must be fully enabled to ensure the success of studies. Using site enablement solutions that can increase efficiency can allow these locations to improve capacity, reduce start up delays and lessen administrative burden, the report said.
Another problem for clinical research sites has been hiring and retaining talent, which Smith said will remain a big issue in 2024.
Speaking to diversity in clinical trials, WCG notes that the FDA recently began requiring pharmaceutical companies to include a diversity action plan with their requests for phase 3 or pivotal trials under the DEPICT Act. This is simpler for diseases with larger patient populations, but more difficult for rare diseases, the WCG report says. The firm believes that 2024 will be the year that the processes for developing these plans standardizes and best practices are formed, meaning learnings can be applied to trials where it may be more difficult to establish a diverse patient base.
There are also better diagnostics available, meaning patients can be identified earlier and connected with emerging treatments and clinical trials.
One of the ways to boost diversity is through decentralized clinical trials, which became necessary during the COVID-19 pandemic as researchers scrambled for ways to conduct important trials while reducing exposure risks. WCG notes that technology can be incredibly helpful and even inspire participants to sign up.
The firm notes the launch of Apple’s ResearchKit, which helped bring on thousands of participants for programs looking at chronic diseases. But after several weeks, 90% of the people had dropped out. So clinical trial sites will have to establish the right mix of virtual and on-site care to keep participants engaged.
Another issue to watch is the rise of drug delivery technology that could allow participants to take vaccines from home using oral, intranasal, and microneedle array patch vaccine delivery systems. The FDA is currently considering whether to allow at-home administration of an approved intranasal live attenuated influenza vaccine. A key question will be how to address safe handling and shipping concerns, WCG said.
AI has taken the world by storm and could be applied to research as well. WCG sees the greatest potential in managing the massive datasets created throughout the clinical journey, protocol development and the ethical review of research.