New York, NY (March 24, 2020) – In response to the ongoing COVID-19 pandemic, the PCCTC has carefully assessed the impact on employee safety and business operations to rapidly identify and triage current risk issues. We have assumed a position of cautious urgency, taking immediate steps to address the challenges in study conduct that may arise due to illness, quarantine, and restricted travel of study subjects, investigators, site staff, and monitoring personnel. We are committed to working with stakeholders to prioritize patient safety, while ensuring both continued access to protocol enrollment/treatments and protocol compliance to the extent feasible during this time. The PCCTC continues to monitor guidance from relevant regulatory authorities and fully supports individual research sites’ need to follow local policy and clinical judgment and prioritize the health of subjects and staff.
Our Scientific Oversight Committee has convened virtually to establish ongoing communication regarding COVID-19 and its effects on PCCTC activities. To best support our stakeholders we are taking critical steps to mitigate potential complications.
•We are gathering feedback from our sites and monitoring the impact of COVID-19 at each site, for each study, to work in close collaboration with our investigators and sponsors to maintain the safety of study subjects, the integrity of study data, and compliance with GCP.
•We are developing study-specific guidance that will be provided in the coming days and will work with sites and sponsors to evaluate and determine appropriate measures to be taken for each study and each subject as needed.
•We are evaluating and implementing alternative solutions to maintain oversight of studies, sites, and subjects where planned study and subject expectations are no longer possible due to the implementation of COVID-19 control measures.
•We are collaborating with our stakeholders, including sponsors, sites, labs, IRB/ECs, and funding partners, to drive the best possible outcomes under the current challenging circumstances.
•We are proactively monitoring relevant guidance from regulatory authorities regarding how to handle COVID-19 related study disruptions.
PCCTC personnel remain available to provide project-specific support however needed to help maintain continued site and study operations.
On behalf of everyone at the PCCTC, I would like to express our tremendous gratitude for the patient care, research, and advocacy communities’ patience and unparalleled dedication during this rapidly evolving situation.
Thank you and be well.
– Jake Vinson