Clinical Trial Participant Support and Risk Mitigation During COVID-19
Sponsors and clinical research sites wish to continue conduct of research so long as patients are adequately protected and willing to participate. Without patients, there are no trials. Block Clinical’s response to COVID-19 aims to help our Clients address the concerns of patients so they feel safe participating.
With the help of our Sponsors, CROs, and Suppliers, we’ve established the “Safe-to-Site” initiative which leverages Block Clinical’s patient support solutions to provide safe and convenient transport for patients who wish to remain in their trial, and have no option but to travel to a research site.
1. Safe-to-Site Initiative Overview
a. Turn-key support for all patients across all trials with ground transportation and reimbursement support
b. Dedicated Patient Coordinators are available by phone, email or text to support patients before, during, and after each Visit
c. Travel is prepaid and pre-arranged on behalf of the patient (may include caregiver)
d. Duty-of-Care program operates in the background, 24/7/365
2. What is being done by our Travel Suppliers?
a. Ground Transportation
i. Removal of all non-essential items from the vehicle i.e. Magazines, Newspapers, Mints, Water
ii. Thorough cleaning of all the hot spots like arm rests, door and window mechanisms, seatbelts, door handles inside and out, door edge, and a good wipe down of surfaces before and after each ride
iii. Hand Sanitizer and/or Wipes onboard
iiii. Floorboards are sprayed with disinfectant
v. Drivers wash their hands frequently and avoid touching their face
vi. As an additional service, some Suppliers offer medically trained drivers (CPR, basic medical) that carry onboard medical supplies
b. Accommodations (UPDATED 5/1/2020)
i. Various levels of housekeeping services will be offered, so guests can limit exposure to others
ii. Plexiglass at the front desk, extra cleaning, sanitizing and hotels will offer guests the chance to do mobile check-in
iii. Ability to offer long term, fully furnished options, including month-to-month – some patients may be safer staying locally for the duration of the trial
c. Airfare (UPDATED 5/1/2020)
i. Travelers should plan on check-in 4 hours prior to departure – new protocols have been proposed that will increase the complexity and duration of the “airport” experience:
1. Online check-in includes option to upload “Immunity Passport”
2. Curbside thermal scans may be conducted on passengers before entering the airport\
3. Bags will be sanitized using fogging machines
4. Passengers may be scanned using BioMind CT (lung check)
5. Bags are sanitized again after security, and tagged as such
6. In the boarding area, seating will be sparse touchless vending machines will replace large shops
ii. Some airlines are using electrostatic fogging machines that disinfect the cabin, effective against COVID-19
iii. Cabins are being wiped down with sanitizer
iiii. Flights are personally inspected before takeoff and may be held for additional cleaning
v. HEPA air filters provide clean cabin air
3. Clinical Research Site Best Practices
a. Provide patient hotlines for general questions about COVID-19, facility information, etc…
b. Additional screening measures for on-premise employees and visitors
c. Limits exposure by allowing patient + 1 caregiver only
d. Provides further evaluation if fever or responses to screening questions indicate a higher level of risk to COVID-19
**New Services Being Offered**
e. Transportation for health care workers to homes and businesses to administer COVID-19 tests
f. Pick-up and delivery of clinical trial samples from patients to laboratories
g. Pick-up and delivery of medicine from Sites to Patients
h. Private medical air charters and ambulatory services for critical patients
Resources
1. COVID-19
2. Travel
c. Simpliflying
3. Block Clinical