How a Clinical Research Site Adapts to Covid-19
Source Data Verification – In order to allow for remote monitoring and the ability to verify source, site staff will need to scan source documents to a secure file hosting service in order to allow the CRAs access to the data, and for Sponsors secure portal entry. These cost $75 per patient visit. I think it is positive that 30% are willing to work with us on this and we will focus on growing that number.
Remote Closeout Visits – These are conducted via telephone or video conference call using a secure network. We request a $1500 one-time fee; $770 is approved on average. Our approval rate has been 20% for these.
Remote Site Initiation Visits – Remote SIVs can be completed via teleconference or videoconference call. The SIV initiation meeting will include detailed review of the protocol, inclusion and/or review of specialized procedures such as diagnostic tests and software programs, direction for safe reporting of case report form, electronic CRF completion, and defining source documents and procedures. They involve a one-time $1000 fee and we have had a 22% approval rate for these.
Remote Patient Safety Calls – Our staff can conduct teleconference or videoconference using secure connections in order to administer the efficacy measures required at each remote safety visit. These are $45 per patient safety call and have been approved on 28% of the cases. We conduct these calls to check in with test subjects and ensure they are doing well, which is important during these times. And everything within the call is documented.
Covid-19 Testing Kits – Our site has implemented necessary precautions for the safety of our patients by providing covid-19 testing kits. Implementation of these minimizes serious health risks for our patients and staff, while prioritizing necessary immediate medical treatment. The cost of the swab plus processing is $98.
Screen Failures Due to Covid-19 – 26% of enrolling studies had sponsors request that all patients currently in screening be screen failed immediately or were not allowed to roll over into long-term extension studies. These can be paid per contract term. Personal Protective Equipment – Our site will require subjects to undergo additional covid-19 screening before visiting the site. Trial subjects will be informed of this requirement and sponsors might need to amend informed consents accordingly. Our site has implemented screening and safety procedures for study personnel who have physical contact with subjects during the trial. These procedures may include the use of protective garments during intake, examinations, or dosing. These additional precautions have been taken to prevent changes and affect trial design and outcomes. Staff has been instructed to follow appropriate infection control practices and use PPE at scheduled and unscheduled visits to prevent risk of exposure. There is either a pass-through or a flat-rate fee which averages $560 a month per study. We have seen 7% of studies approving the flat-rate fee and 26% approving the pass-through fee. The average cost of the PPE is:
Enhanced Cleaning Supplies – Cleaning staff are required to clean and disinfect their work areas, including any frequently touched surfaces, throughout their workday to prevent exposure and minimize spread of covid-19. Additional items, such as disposable gloves, diluter disinfectants, and at least 70% alcohol are required during the disinfecting process. The cost of this is pass-through and 27% of our studies have approved it.
Retainage Release – It is of critical importance to communicate this to our CROs and sponsors. Given the unknowns of the pandemic trajectory and the extent of the impact the virus could have on site operations, study holds and delays, staffing needs and safety, and the increase in necessary precautions, we contacted all studies with outstanding retainages. This included those that were due and those that were not per the CTA. Getting up to speed once all of this is over will be difficult if the cash flow is not there.
Contract Payment Terms – Visits performed and all study-related expenses will be paid on a monthly basis and should be paid on within 30 days of sponsor’s invoice receipt. These monthly payments will assist us with cash flow and eliminate any financial burden on our sites. Furthermore, they will ensure the stability and infrastructure of our sites.
Increased Overhead – Due to the covid-19 pandemic, we have increased overhead expenses, including staffing agency fees incurred for business continuity purposes and increased IT support. Specifically, there is a 5% overhead to cover covid-19 operational costs.
Advance Payment – These will make future decisions straightforward and minimize disruption to our research activities. They will also allow our sites to perform as usual in the event of any unexpected expenses, while maintaining contractual obligation to the sponsor and providing high-quality patient data. Normal costs expended with advance payments are administrative indirect costs and patient study expenses for activities and services that benefit the study, such as study-specific materials, staff, and consulting services. Advance payments will ensure the stability and infrastructure of sites, and cover the increased costs of site modifications and accommodations, such as short -term staff childcare and IT infrastructure.
This has been a great conversation. We did not get to hit budgets but, in general, we have been seeing some of the same situations. Let’s now jump into questions from the audience.
Did you get reimbursement from sponsors for advertising virtual screens?
We were getting reimbursements for community outreach. I asked my team to contact clients who had provided prior approval or those who had not yet provided any, and explain to them with the success metrics we had. This provided proof that these tactics were working, which allowed us to be reimbursed for our digital marketing efforts.
How comfortable are sites with tools such as e-consent, e-source notes, and are there any suggestions in using telemedicine platforms?
We are looking into that as a potential business model. I think what is needed is all surmountable in order to execute, but we have not yet gotten there, though.
How did you manage covid-19 within your inpatient facility?
We manage covid-19 through daily health checks. We check the temperature of volunteers and soon staff before entering the facility, we maintain distancing rules in the building including patient rooms, use sneeze guards, PPE, and increased sanitization at every touch point.
Does your staff work at other facilities?
Have you had any SAEs due to positive covid-19?
No SAEs due to positive covid-19
How accommodating are the sites on having almost all virtual site visits including selection, initiation and remote monitoring visit?
Which covid-19 test are you using and where are you purchasing it? How do you like it?
We bought them from our local lab, Ecco Lab Group and they are $98 inclusive of processing. They have been reliable and take up to three days to provide results.
Other than McKesson, where do you recommend getting personal protective equipment from?
We bought our PPE from local vendors.
* This blog post is based on a webinar which took place on Thursday, May 14, 2020. You can access the recording here.
About Bonnie Segal
Bonnie Segal is the Co-Founder and President of Segal Trials. She also holds the position of President for each of the six affiliated site entities that Segal Trials represents. She has been in medical research for 18 years and leads Segal Trials’ business development, operations and recruitment teams, as well as the company’s community advocacy initiatives, staff engagement, and staff leadership programs. Bonnie has been a crucial part of the success of over 1,000 clinical trials conducted by the six affiliated site entities at nine research locations throughout South Florida and South Carolina.