In the city where the pandemic hit the hardest, we had to A) Evolve, and B) Predict.
– Dr. Judith Joseph, Principal Investigator and psychiatrist at Manhattan Behavioral Medicine.
When COVID started to spread in early March, Dr. Joseph reached out to colleagues working abroad in Hong Kong and China for advice. Based on these discussions, her site implemented COVID SOPs (i.e., requirements for PPE, cleaning measures, temperature checks) a month earlier than the rest of New York state and could make informed predictions. Consequently, her site was able to stay open throughout the pandemic while also keeping staff and patients safe.
As Dr. Joseph’s site conducts pediatric, adolescent, adult, and geriatric psychiatry and neurology studies, many assessments could be conducted remotely. She also noted that having proper electronic platforms was essential to completing them smoothly and collecting accurate data points. For the studies that did not allow for remote data collection or remote visits (e.g. investigational product must be administered by clinical research coordinators, interventions that cannot be done through telemedicine), Dr. Joseph’s site prioritized those patient visits. A color-coded schedule was created to map out on-site vs. remote visits, and on-site visits were always scheduled in the morning to account for other potential issues (i.e., changing courier schedules, changes to shipping hours). For any study with remote flexibility, visits are planned out for at least 2-3 months in advance.
Manhattan Behavioral Medicine also set up third-party courier workflows for the delivery of investigational products to patients. After training with a Fedex manager, couriers completed test runs. The site also conducted video tutorials with patients via video calls to show them what the package would look like and how to exchange newly dispensed medication with IP that needs to be returned.
On the subject of sponsor communication, Dr. Joseph explained how crucial early and continuous communication was in establishing a sense of trust. Given the constantly evolving nature of the pandemic, her site frequently encountered new situations and had to adapt accordingly. Having strong relationships with monitors, her site was able to get quick advice on how to handle an issue. “If a patient couldn’t come in, I would text the medical monitor and say, this is what’s happening,” said Dr. Joseph. “Because there is already a level of trust, they trust my clinical judgment and will extend a window for a visit, or allow certain deviations.”
Dr. Joseph also made a point to meet with all team members to understand their perspectives and listen to any fears or concerns. “We did not shame people for not wanting to come in. Instead, we validated everyone’s feelings which helped with morale,” explained Dr. Joseph. She then explained how without her team, her site would not have been as successful. Interestingly, the model or concept of site hierarchy that previously existed has been replaced with broader roles and increased collaboration and teamwork.
As sponsors start to ramp up clinical trial activities amid the ongoing COVID-19 crisis, site directors should onboard some of Dr. Joseph’s successful strategies:
- Predict what the worst-case scenarios are and plan for this ahead of time. Although they may not happen, your site will be more equipped to respond.
- Maintain strong relationships with monitors and keep lines of communication open.
- Establish clear workflows for all aspects of a study visit (i.e., IP delivery, home visits).
- Plan ahead. Determine what visits should be prioritized at your site for the next 2-3 months.
- Understand how your site staff is feeling and address their concerns.
- Stay up to date on COVID and current events. Share resources with your team.
- Take inventory of your PPE.
To hear more about Dr. Joseph’s experiences and strategies for navigating clinical research during the pandemic, listen to the full webinar.
- Dr. Judith Joseph, Investigator and Psychiatrist at Manhattan Behavioral Medicine, PLLC
- Al Peters, President of BTC Network (Moderator)