SAN DIEGO – How effectively a sponsor, CRO or site responds to a trial-disrupting emergency all depends on the planning they do long before disaster strikes.
Don’t wait to prepare, Jennifer Sheller, Merck’s North American regional head of global clinical trial operations, advised attendees at the Drug Information Association conference last week.
Sheller shared lessons Merck has learned from helping its trial sites through hurricanes and other difficult situations. Common issues that hinder a site in emergency conditions include inability of patients to get to their scheduled visits or site staff to show up on time for their shifts. Supplies may be lost or inaccessible, electricity and phone lines may be down.
Establishing what Merck calls an incident management team (IMT) requires the participation of several different functions, including human resources, quality, clinical supply and data management. The response plan should include a chart that outlines all team members’ roles and lines of communication, as well as a list of all team members’ and trial staff in positions of risk.
Create an IMT that can hit the ground running, Sheller said, stating that her current team can pull together within 30 minutes, fully able to meet and prepare for what lies ahead.
Ray Policare, global monitoring partner lead for Merck, focused on team members’ safety when in a dangerous environment. A check-in system should be a priority. Sheller suggested the use of a geospatial tracking tool to monitor the locations of team members, site staff and patients. Phone trees, maps and lists of staff in positions of risk all can be helpful.
The IMT also should be able to pack essential items and evacuate quickly, Policare said, if the situation becomes dangerous, a lesson he learned personally when his home in California was threatened by a wildfire.
Communication also is essential to Merck’s plan, and not just among team members. Policare encouraged the use of line managers to communicate information regarding staff safety all the way up to the CEO.
He said Merck’s response team in the past has had trouble keeping up with developments on the ground — weather changes, etc. — and so has included links to helpful resources such as NOAA, the National Weather Service, CalFire and Ready.gov. in the company’s preparedness plan.
Emergency response for clinical trials means more than assisting patients and site staff, however. Documents should be protected as well. A preparedness plan should direct sites to regularly secure and backup all their data, and the response team should maintain a high level of detail in its documentation of the relief effort, recording in the trial master file such information as the number of sites impacted, issues with patient access to the trial drug, and changes in scheduled monitoring visits.
To ensure your sites are ready to handle unexpected events, revisit your emergency preparedness plan often. Having site staff sign and acknowledge standards of practice only goes so far, Policare said. Implementing mandatory annual training along with running mock-disasters can help increase everyone’s readiness.
