COVID-19 has been a tragic wrecking ball on several fronts, but something that isn’t mentioned much is clinical research.
Long a linchpin at CHOC and, moving forward, poised to become even more central as CHOC evolves into a leading pediatric health system, clinical research has had to quickly readjust under the strain of the pandemic.
But out of these dark days have emerged several lessons on not only how to continue research during a crisis, but how to keep it thriving.
That was a key message delivered by Phuong Dao, director of Research Operations at CHOC, during a recent webinar beamed around the country.
“There’s a renewed sense of energy and purpose to use science to solve problems that are important to our patients and the public,” Phuong said during a panel discussion that was part of a two-week summit on rare diseases hosted by Global Genes, an Aliso Viejo-based non-profit that advocates for the rare disease community.
“I think we can really harness and leverage this shared renewed energy and translate that to the conducting of rare-disease trials,” Phuong said.
The panel, speaking on “Proactive Planning for Continuity of Research During a Crisis,” also featured moderator Nina Wachsman, founder and president of Augur Health, a New York-based clinical research recruitment firm, and Gerald Mosely, founder and principal of CP&P Development, a Sacramento-based specialty consulting firm focused on pharmaceutical sales and operations.
Wachsman laid out some realities hospitals face during COVID-19:
- Less access to doctors and inpatient visits
- Less interest in research into rare diseases
- An explosion in telehealth visits
- E-signatures for informed consent
- Nurse home visits
- Lab tests done remotely
As for clinical research, Wachsman said, challenges include a lack of available capital, a lack of access to enough clinical trial participants and the ability to retain them, and getting the attention of the FDA at a time when COVID-related studies dominate.
And in a world of virtual meetings, Mosely noted, effective teamwork can be a challenge.
“The people aspect is what can make or break things,” Mosely said. “Successful outcomes can be affected more by interpersonal than technical skills.”
But bright spots abound, Phuong said.
COVID-19 studies can serve as a template for clinical research well beyond the end of the pandemic. “We have seen study teams form quickly and multi-disciplinary teams mobilize,” she said.
The contracting and budgeting processes for COVID-19 studies have accelerated and teams involved in “master trial protocol” studies involving multiple hospitals have readily shared resources, when in the past there were more hurdles.
“This focus on leaner and faster clinical trials can be leveraged in the rare disease space as well,” Phuong said.
Other positive changes introduced during the pandemic that can affect all clinical trials moving forward include:
- Fast tracking by the Institutional Review Board (IRB)
- The acceptability, and patient popularity, of telehealth
- Home-based testing and monitoring technologies
- Curbside/courier pick-up and delivery of participant samples and investigational products
- Digital data collecting tools
- Remote Site Initiation Visits (SIVs) and monitoring
- Less reliance of participants having to be on site
Phuong noted that clinical trials involving kids impact entire families, one of the things that makes pediatric research different from studies involving adults.
The consenting process is unique, she added, and some teenagers who still are minors sometimes have a different opinion from their parents when it comes to treatment plans.
Moving forward with telehealth, Phuong said, clinicians need to think about how to engage with study participants in the languages they understand best.
And there are other questions that need to be addressed, including:
- How research should be structured to adapt to new realities
- How to keep motivation high to conduct clinical studies into rare diseases
- How virtual meetings and healthcare visits affect productivity
“I hope that we sustain the gains we have made to move toward more efficiently and that we are able to approach clinical research in ways that are more streamlined and modernized,” Phuong said.
To learn more about CHOC’s Research Institute, click here.