Conversations and healthy debate about issues facing our industry and the healthcare system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
Today, we are pleased to welcome a guest post from Jim Kremidas, executive director of the Association of Clinical Research Professionals.
Before the coronavirus pandemic, clinical research sites were already operating on low margins, and often faced tight financial constraints and understaffed workforces. According to a survey by Society for Clinical Research Sites (SCRS) released in early April, 59% of sites in 2019 reported that they had three months or less of operating cash.
Now that COVID-19 has upended the landscape, the clinical trial infrastructure is six months to a year away from crisis conditions that will increase costs and slow the pace of drug development. The time is now for sponsors and sites and other interested parties to come together to talk about potential near- and long-term solutions.
An early April study conducted by Continuum Clinical in partnership with ACRP found 31% of clinical research study sites fear total closure, as COVID-19-related stay-at-home orders and patient concerns over interacting with health care professionals continue to increase. Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.
Of the sites who reported patient dropouts:
- 80% said patients are unwilling to visit the site for study appointments
- 52% indicated they believe patients fear interacting with any medical professionals who may be in contact with COVID-19 patients
- Only 19% of sites said they thought patients would permit home nursing visits by clinical trial staff, a method recently offered by the FDA as an acceptable substitute for scheduled drug administration study visits
The survey also shows investigator sites are facing serious staffing issues, with 38% reporting employees experiencing difficulties working from home and 33% reporting employees are not fully engaged due to coronavirus-related disruptions.
The health of our clinical trial site ecosystem is critical to providing data to the frontline health care workers battling COVID-19 and the myriad of other challenges they face. The clinical trial workers of today are helping to inform the medical breakthroughs of tomorrow.
Sponsors need to understand how this pandemic is curtailing clinical trial activity and putting many sites on the very edge of financial existence. If we lose a wide swath of sites and clinical trial professionals during this slowdown, it will be costly and difficult to rebuild. The sooner we begin to address our looming problem, the easier it will be to mitigate any damage. Now is the time to think of creative ways to support investigator sites that are in peril of closing their doors.
Thankfully, we have a strong foundation to build upon. In recent months, regulators have stepped up with innovative and flexible approaches to help advance potential Covid-19 treatments and vaccines. Sponsors and others have leveraged some of the best aspects of decentralized clinical trials, remote based monitoring, and real-world evidence. In the future this period may be referred to as the “Covid-Catalyst” due to the impact it’s having on advancing clinical operations. As an industry, we are rising to meet a huge challenge with nimble thinking and powerful resolve.
Like others in the health care industry, clinical trial practitioners are on the front lines engaged in life or death work to protect patients and improve quality of life. We owe it to the greater public health to support their vital work.
Jim Kremidas is the executive director of the Association of Clinical Research Professionals, a trade association representing over 13,000 clinical researchers around the world. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He spent the first 24 years of his career at Eli Lilly and then worked at various CROs for the next six. He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials).
Guest Contributor The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view on issues facing our industry and the health care system.