Disaster Planning Primer
If disaster were to strike your facility, would you be ready?
Sites impacted by recent disasters share their experiences
Clinical trial sites and research administrators across the country witnessed the devastation caused by Hurricane Katrina with both personal and professional alarm.
Many clinical trial sites in New Orleans and neighboring areas were closed and some may never re-open. Others were moved miles away and are coping with financial stress. Even the larger sites, which have tried to return to business as usual, have found that it’s very difficult to contact patients/subjects when the contact information is located in offices that were closed for weeks and when the trial participants have been scattered to cities across the country.
Six weeks after Hurricane Katrina, more than two-thirds of the clinical trial sites in the New Orleans area were not up and running or they were operating on a limited basis, says Alicia A. Pouncey, MEd, managing director of Aureus Research Consultants in Metairie, LA. Aureus Research performs contract monitoring of clinical trials.
Some clinical trial staff have lost their jobs because of the disaster, and many others are worried about potential job loss, Pouncey says.
"Medical facilities are trying to maintain care for patients, and clinical trials are way down the pole on what’s important," Pouncey says.
The Office of Research Services at the Louisiana State University Health Sciences Center of New Orleans had its operations moved to the Pennington Biomedical Research Center in Baton Rouge, where there is limited office space for temporary use, says Kenneth Kratz, PhD, director of the Office of Research Services and the manager and co-chair of two IRBs.
"In the meantime, we had done the office of research services’ work over the Internet to the extent possible," Kratz says. "I had evacuated to St. Louis with my family and ended up staying in a house of a friend of a friend in Logansport, LA."
Since hurricane threats are nothing new to Gulf Coast residents, it’s not unusual for people to have to evacuate once or more per year, Kratz says.
"When we left school on Friday before the hurricane, I just figured it was another scare," Kratz says. "I thought we’d leave town and be back in a couple of days, and so I blanked out and left my laptop in my office."
Then Hurricane Katrina struck and it was several weeks before Kratz could return to his suburban home, which had only wind damage. He was able to retrieve his desktop computer from his home. "I was able to contact all of my staff by the second week and had established rudimentary communications with them," Kratz says. "That was one of the most difficult things for everybody — having so little communications capabilities in terms of personal business."
More than six weeks after the hurricane hit New Orleans, Kratz still didn’t know the status of all of the research projects.
"If a study is company-sponsored, we hope they have contacted sponsors for those clinical trials, but I don’t know whether they have," Kratz says. "We have contract issues, but we don’t have access to all of our contracts until we get back into our building in New Orleans."
Meanwhile, Kratz’s staff are trying to make contact with principal investigators and find out the status of their studies. The research office manages about 1,500 projects of which 500 to 600 are above minimal risk, Kratz notes.
"All the PIs have been displaced from the city and ended up all over the place," he adds. "Many of our investigators may just now be getting Internet connections back."
The evacuation, which stretched into weeks, has impacted hundreds of research professionals in the region. "There are a couple of hundred research professionals in the affected areas and thousands of clinical research subjects who were recently active in trials," says Norman M. Goldfarb, managing partner of First Clinical Research in Palo Alto, CA.
Goldfarb suggests that the clinical research industry can turn this huge disaster into a huge opportunity by strengthening the clinical research community by providing help specifically to clinical trial subjects and research staff.
For instance, many pharmaceutical companies have distributed free medication to people in the impacted areas, and this benevolence should be extended through sites to participants at clinical trial sites in the disaster areas, Goldfarb says.
"This would tell the public that the clinical research industry looks out for study participants," he adds.
Other measures could include having clinical research people donate their frequent flier miles to research peers who have to commute between New Orleans and temporary offices, Goldfarb says.
Goldfarb is organizing a fundraising series of teleconferences in January. The educational sessions will cost $99 each or three for $249, and 80% or more of the money will be directed to a nonprofit foundation to help hurricane victims within the clinical trial industry, Goldfarb says.
"There will be two categories of recipients: staff and subjects," Goldfarb adds.
Registration for the teleconferences is available on First Clinical Research’s web site at www.firstclinical.com.
Disaster planning not a priority
Until Hurricane Katrina showed the industry the possibilities of a major disaster, clinical trial sites might have looked at disaster planning as the last item on the priority list.
"We did not give disaster planning any serious thought until Katrina hit," says Tom Davis, PharmD, chief executive officer and president of Odyssey Research Services in Bismarck, ND. The company is a site management group.
The most common disasters to strike Bismarck are blizzards in which transportation and power might be impacted for a few days.
"We have a written policy on disaster recovery for our IT systems, but that’s not because of the potential for a natural disaster, but because of the nature of computer systems and having systems crash," Davis says. "We’re in the process right now of revisiting our disaster plan."
Davis predicts that sponsors soon will be asking clinical trial sites whether they have any standard operating procedures (SOPs) for disaster planning. "I think in the future sponsors will be looking at whether or not investigators have some sort of disaster plan for maintaining the integrity of documents for something such as a tornado or flood or that sort of thing," Davis says.
Goldfarb has written an emergency action plan template for clinical trial sites. (See excerpt from emergency action plan.)
One of the most important actions a clinical trial site can take is to arrange for an offsite backup of electronic and other data, Goldfarb says. "The industry as a whole doesn’t think about this very much, and most study records are stored at the site," Goldfarb says. "So if there’s a disaster or emergency the records could be destroyed or damaged or inaccessible because the police won’t let site staff back into the building."
While clinical trial and research offices experience difficulty in contacting principal investigators, the PIs may find it daunting to contact their subjects after a disaster, Kratz says.
Some New Orleans investigators opened up clinics elsewhere and have continued with their clinical trials, but many were having trouble finding subjects in the first months following the hurricane, Kratz says.
Kratz spoke with a cancer center’s study coordinator and asked how extensively the center had lost contact with patients on clinical trials, and the coordinator told him that in some cases the center had lost contact with 100% of the subjects.
For a contract monitoring service like Aureus Research Consultants, the evacuation posed a less severe hardship, Pouncey says. "For a business like ours we can restart wherever there’s an Internet connection and an airport," Pouncey says. "But you have to make provisions for record storage."
When Pouncey evacuated from her home and office, the only things she took with her were her laptop computer, her dogs, insurance papers, and tapes that were the back up for the computer server data.
"I had information in the laptop and server tape that would allow us to do our business somewhere else the next day," Pouncey says.
Pouncey says she’s concerned about the personal impact the disaster has had on clinical trial coordinators and other research staff.
"They may be thinking about their home being destroyed, but also wonder whether they still have a job," Pouncey says. "If they haven’t heard from their employer, they’re in a mental limbo."
Disasters, like other major life crises, bring out both the best and worst in people, Pouncey notes.
While many sponsors and others in the research industry were very supportive after Katrina struck, there was one phone call Pouncey had that was particularly jarring, she says.
"One sponsor called to ask, How is our EKG machine?’" Pouncey says. "I think, I don’t care—I have an employee with 11 feet of water in her house, and it’s just a machine.’" Anyone calling from outside the disaster zone should first say, "I hope you and your family and staff are all right," Pouncey suggests.
The research office at Louisiana State University Health Sciences Center is working toward conducting business as usual and may even open a couple of new studies, but progress has been slow, Kratz says.
"It’s dependent on PIs finding a place to work and a place to see patients and subjects and accrue subjects," Kratz says.
"So we hope to get some normalcy back, and that’s a common word you hear around here—normalcy," Kratz says. "It’d be so nice to have something normal right now, but we don’t have that yet."