Making the Inaccessible, Accessible at Home
How Virtual Clinical Trials are Changing Clinical Research
When Hope Biosciences Stem Cell Research Foundation (HBSCRF) submits a proposal for a clinical trial or expanded access study to the FDA for authorization, also called a “protocol,” we are asked to assign a clinical trial site. The clinical trial site is where all records are kept pertaining to the study, and usually where treatment is administered. The location may be a hospital, university, doctors’ offices, or community clinic; we conduct nearly all of our studies here at HBSCRF headquarters in Sugar Land, Texas.
The COVID-19 pandemic sparked a significant change in clinical research methodology as pertains to clinical trial site selection. Stay-at-home orders and fear of transmission made patient travel prohibitive. How could research studies be safely continued; how could we keep our patients out of harms way without disrupting treatment? The answer was the same one arrived at by many others in the healthcare community — virtual medicine.
Traditional clinical trials require participants to make regular visits to the clinical trial site. In a virtual clinical trial (VCT), also known as a remote or decentralized trial, the trial site remains the designated location for the primary investigating physician, the trial coordinator, and all patient records. Portions of the study, which may include treatment, safety monitoring, or data collection, are authorized to take place in another location, such as the patient’s home.
“We had two expanded access studies underway that were authorized by FDA to shift to virtual trials once the pandemic hit,” recalls Registered Pharmacist and HBSCRF Clinical Research Associate Linette Rehkopf. “It was a wonderful opportunity for the patients to continue to receive treatment.”
In order for a remote location to be approved by FDA, the same standard of safety that a patient would find in a medical institution must be proven and established. While that is relatively simple in trials investigating the use of say, pills or creams, HBSCRF’s studies have an additional layer of complexity because mesenchymal stem cells usually require intravenous administration.
“This is unlike any work I’ve previously been part of,” shares Sherry Diers, RN, who has served as a nurse for 30 years, including four years working with stem cells first at Hope Biosciences, then at HBSCRF. “These stem cells are living things. It’s not like administering an antibiotic or a static drug, which is a reason why we take training of the nurses supporting virtual trials seriously. We provide in-person or live instruction and a written standard operating procedure detailing how to prepare cells for infusion; our current training model also requires the remote nurses to be supervised by a nurse from HBSCRF during their first infusion.”
To meet HBSCRF safety criteria, treatment at the remote location must be given and vitals monitored by a Registered Nurse (RN) with an Advance Cardiac Life Support (ACLS) certification and a Basic Life Support (BLS) certification. A back-up nurse must assist. The nurses must develop and be well-versed in an emergency plan, including access to the nearest emergency room and staging of an anaphylaxis kit. The remote nurse receives a supply kit from HBSCRF the day before treatment, including the stem cells, shipped in a refrigerated cooler, and specialty items such as filtered tubing and blunt needles.
Day of, treatment is a three-hour process, all of which is supervised by HBSCRF clinical staff through a secure, HIPAA-compliant video call. During the first hour, the patient meets virtually with the primary investigating physician and the nurse completes any needed lab tests, including blood or urine samples. During the second hour, the intravenous drip is set up and the stem cells are administered. Finally, the patient is monitored for an additional hour post-infusion.
While at present HBSCRF only conducts VCTs with individual patients in expanded access studies, the team is capable of scaling their efforts to larger remote trials if and when that solution makes sense. Factors influencing the decision to pursue a VCT may include the patient’s physical condition and their willingness or ability to travel, which may be impacted not only by geographical location but also by access to tools such as adapted vehicles at the necessary times, or caretaker availability to travel with the patient. In general, VCTs are most well suited to studies that have successfully completed Phase I trials and so have confirmed patient safety; studies that focus on chronic rather than acute health issues, where the risk of requiring emergency care is higher; and studies requiring relatively straight-forward measurements, rather than specialized equipment such as MRI or CT scans.
Whatever form they take in the future, the enhanced accessibility, streamlined process and cost-cutting represented by VCTs means that clinical research organizations like HBSCRF are committed to continuing them. In their “Trial Insights” data analysis series WIRB-Copernicus Group (WCG) an FDA-approved Institutional Review Board (IRB) administrator, reports that nearly three quarters of the sites surveyed plan to continue to use telemedicine after the pandemic subsides. Two thirds plan to continue using remote trial coordinators, compared to only 15% before the pandemic, and remote trial monitoring is also seeing an upward trend. Large companies additionally report that virtual trials are a boon to recruitment, which may open up clinical research to increasingly wide and diverse groups of participants.
HBSCRF, headquartered in Sugar Land, Texas, exists to revolutionize medicine by accelerating translational research in regenerative medicine to develop cures for all. To date, HBSCRF has obtained FDA authorization for 16 clinical studies in 10 disease areas. Clinical trial authorizations encompass COVID-19 prevention and treatment, Alzheimer’s disease, and traumatic brain injury (TBI). Expanded access protocol authorizations include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), severe osteoarthritis, Parkinson’s disease, spinal cord injury, Cerebral Palsy, and chronic musculoskeletal pain. Launched in March 2020, in its first year of operation HBSCRF administered nearly 100 billion cells at zero charge to patients.
HBSCRF is administered through the Greater Houston Community Foundation (GHCF). As one of the leading philanthropic grant makers, GHCF is proud to partner with donors to create a meaningful and long-lasting impact in our community. Learn more at hopebio.org.
