Guidance to Help Respond to Immediate Challenges
As the COVID-19 outbreak challenges clinical trial sponsors, we’ve identified efforts to support patient and site engagement - helping to minimize clinical trial disruption and keep timelines intact. Some efforts respond to FDA guidance on conducting clinical trials during the COVID-19 pandemic while others respond to challenges introduced by travel restrictions, infection risks, enhanced site burden, and protocol deviations.
As many sponsors weigh the decision to suspend new studies, the guidance presented here is designed to help sponsors in their efforts to keep current studies on track. BBK Worldwide recognizes the challenges of the evolving COVID-19 environment and is available to help you identify and quickly implement solutions to minimize disruption to your individual studies.
Maximizing FDA Guidance on Conduct of Clinical Trials during the COVID-19 Pandemic
The FDA’s recent guidance is designed to assist sponsors in ensuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. We have outlined some of the FDA recommendations below along with our solutions to help you address them.
“Ensuring the safety of trial participants is paramount. Sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify study conduct accordingly. Study decisions may include those regarding continuing trial recruitment, continuing use of the investigational product for patients already participating in the trial, and the need to change patient monitoring during the trial. In all cases, it is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.”
Strategies to Respond:
Patient and Site Communications
- Put a crisis communication plan in place, with a multidisciplinary team prepared to address all concerns related to patients and study sites staff.
- Create a formalized process for the development and implementation of communications to keep patients and sites informed of study modifications
“ . . .sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented…. In some cases, trial participants who no longer have access to investigational product or the investigational site may need additional safety monitoring (e.g. withdrawal of an active investigational treatment). If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self administration, may be amenable to alternative secure delivery methods.”
Strategies to Respond:
Air Travel Optimization
If your study currently involves air travel, prepare for disruptions.
- Adjust existing air travel by re-routing flights and / or substituting ground travel for air travel when possible.
- Extend participant visas to allow for long-term stays.
- Schedule short-term housing for patients and caregivers, either to avoid travel back and forth from (or through) countries of concern, or to provide an adequate quarantine period prior to study visits for potentially affected travelers.
- Look for opportunities to put precautions in place for air travel – e.g. book first class seats or multiple seats in economy to increase personal space.
Study Apps / Patient Portals
- Leverage study apps and patient portals to facilitate two-way communication between patients and site staff with instant messaging and video chats.
Try to engage or modify ground transportation to support efforts to continue in-person visits.
- If you are currently using a car service to transport patients to and from site visits, make sure preventative measures are in place – e.g. frequent disinfection, removal of printed materials, removal of beverages and snacks (e.g. bottled water), latex gloves for drivers and passengers, and hand sanitizer.
- If you are currently not using a car service to transport patients to and from site visits, now may be a good time to reconsider. Many patients indicate enhanced confidence and comfort maintaining site visits when they are offered an alternative to public transportation or ride-sharing services.
- Arrange for the transportation of the study drug to patients using a specialized home delivery service.
At-Home Study Visits
While some sites may be able to remain open, others may close – or in-site visits may be replaced with remote visits to minimize in-person contact.
- Make sure you have site-patient remote communication modalities in place (iPads and Zoom accounts to ensure optimal communication).
- Leverage ground transportation to facilitate study staff traveling to the patient’s home to conduct routine blood draws or administer the study drug.
- Equip traveling study staff with mobile devices to record the patient’s health status and a summary of the visit.
“For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended.”
Strategies to Respond:
Auxiliary Site Staff
- Conduct assessments to identify sites’ current and anticipated status for remaining open, closing, or limiting patient visits to exclude study visits.
- As staff capacity may be strained, engage additional support specialists to assist with all aspects of study execution and study-related patient care.
Nurse Call Centers
- Augment site staff for new / additional duties related to managing participant engagement.
In addition to these solutions, there are many more that can be customized to meet your specific needs. Our team is staying on top of the evolving COVID-19 environment – including the latest guidance and regulations – and will be sharing frequent updates.