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H1N1 outbreak should spur CT sites to prepare
Disaster plans need pandemic specifics
As often happens with epidemics, the influenza A (H1N1) virus infection that began in Mexico in April started small, but jumped across the North American continent with breathtaking speed.
The number of confirmed cases of the new and sometimes lethal strain of virus more than doubled from one day to the next. Hospitals quickly sent alerts to staff, and emergency preparedness plans were activated in readiness.
For clinical trial professionals and investigators, determining how seriously to take the burgeoning pandemic was difficult, given its arrival at the end of the usual flu season and its inconsistent virulence.
Even if this particular virus eventually proves to be a false alarm, it serves as a valuable lesson to CT sites. And it could be a harbinger of an even worse flu pandemic this fall and winter when flu season is fully underway.
"Our hope is this will die out over the summer, and the flu season comes to an end," says Ramesh Gunawardena, MBA, director of clinical trial operations for Beth Israel Deaconess Medical Center in Boston, MA.
"But the problem with these types of viruses is they take place elsewhere too, so there are international issues," he adds. "So there is a chance it can resurface."
Or another new, virulent virus could emerge.
"One lesson it does teach us is that it's possible we could have an outbreak of some infection similar to this that would cause a much bigger problem," says Edwin V. Gaffney, PhD, a clinical research consultant in Birmingham, AL.
"So it's a good exercise we're going through," Gaffney says.
For clinical trial sites, the lesson is to be prepared with policies and procedures that are specific to the site and not dependent entirely on the larger research institution or medical center.
"Absolutely, you should have your own epidemic protocol," Gaffney says. "It doesn't require a lot more than what the hospital already plans to do, but you do need a policy and procedure in place that is outside of the hospital's policies and procedures."
The CT site's P&Ps should be written within the context of research studies and perhaps address these questions:
The P&Ps might leave answers to some of these questions up to investigators to make on a case-by-case basis.
For instance, it would depend on the trial and the investigator's discretion whether or not to keep a participant who is being treated with oseltamivir (Tamiflu®) or zanamivir (Relenza®) on the study protocol.
"I think that would be at the discretion of the investigator about whether to use Tamiflu and whether to take the patient off the study or leave him on the study," Gaffney notes. "They shouldn't make a knee-jerk reaction because it might be valuable for the study to get data on the interaction of a medication for flu or infection and the drug that's being tested."
Also, principal investigators will have to base decisions about how to handle sick patients according to their trial's inclusion/exclusion criteria, Gunawardena says.
"It could be that if certain drugs are given to the patient, and drug interactions are part of the exclusion criteria that was predefined in the protocol, then the patient would have to come off of the trial," he says.
"It's a health care decision, as well," he adds. "If the patient's health is deteriorating, and the patient cannot meet the timelines of the protocol, then you'll have to weigh the pros and cons of keeping the patient on the trial."
CT sites need to have a contingency plan if their investigators and nursing staff are called to work in emergency care during a pandemic response at a medical center, Gunawardena notes.
"We might not have the capacity to continue on the clinical trials we're working on if they pull all of our staff to handle the emergency," he says.
Or if the clinical trial space is impacted by a pandemic emergency, then the CT site might need to find alternative space for meeting with study participants, he adds.