Timir Kumar Shah
Divyam Institute of Psychiatry, India
Title: Managing non-covid trials at site level during covid pandemic
Biography
Biography: Timir Kumar Shah
Abstract
On 11 March 2020, WHO declared an outbreak of COVID-19 pandemic followed by lockdowns across the globe. This unprecedented event caused unique challenges: travel restrictions, social distancing, infection risk to trial participants and staff, self isolation if infected, stricter sanitisation , restricted resources, etc. In spite of help available in the form of guidelines from regulatory authority, amendments from Sponsor, virtual training and monitoring from CRO - innovative solutions and mitigating strategies were needed at local level.
Challenges were multifaceted. Sponsors amended documents and procedures, which has to be implemented after approval from Ethics Committee . CRO started remote monitoring and auditing. Simultaneous Communication with sponsor and CRO at one end , and with trial participants at other end was need of time . IMP shipment was disrupted. Samples had to be retained at site for longer time. Data collection to the possible accuracy was required. Due to minimal face to face interaction and need to reduce footfalls at hospital, ICF process became challenging. Assessment schedules were revised . Enrolment had to be paused, and retaining participation faced toughest trial. On site activity were replaced by home visits. Protocol deviation has to be documented briefing extent of affect and rational for deviation. Most critical was to ensure participant’s safety and keeping track of adverse events.
Lessons learned will be helpful in designing and managing trials in the future.