Public education program successful with PAD trial
Research coordinator explains process
The Public Access Defibrillation (PAD) trial experience offers clinical trial administrators a firsthand look at how to conduct extensive public education in the absence of individual informed consent.
The trial, funded by the National Heart, Lung and Blood Institute, was designed to evaluate how well nonhealth care providers, when equipped with training in CPR and automated external defibrillators, could improve the survival rate of sudden cardiac deaths in the United States, says Shannon Stephens, a research coordinator at the University of Alabama at Birmingham (UAB) in Birmingham.
PADs were installed in hundreds of public areas, including shopping malls and recreational facilities in 24 communities across the United States, and personnel at the PAD sites and control sites were trained in CPR, Stephens says.
"They were taught how to respond if someone has a cardiac arrest while on the property," says Stephens. "We trained volunteers and tried to identify staff who would be on site anytime the building is operational."
The 2½-year study showed that survival rates from heart attacks were double in the sites that had PADs, he says.
Part of the IRB process included a waiver of informed consent because cardiac patients, obviously, are unable to consent to enrollment at the time they could become a subject, he says.
"It was the goal of the IRBs to approve the process that’s outlined under the waiver of informed consent," Stephens says.
There were 101 IRBs that approved the study, and the median time it took to achieve approval was 108 days.
The IRBs required study sites to conduct community consultation and public disclosure, as part of the regulations under 21 CFR 50.24, and investigators conducted nearly 12,000 activities to satisfy these requirements.
"Each IRB was responsible for their localized community," Stephens says. "Most IRBs requested about two revisions."
The IRB handling the UAB study site required clinical trials staff and investigators to hold a public forum to discuss the trial, several press releases, the distribution of letters and brochures, and media coverage in radio, print, and television, he reports.
"Our public forum was held at a centralized community meeting facility on the UAB campus," Stephens says.
The principal investigator spoke about the clinical trial and why scientists felt it important to research the topic, he recalls.
"We gave a brief presentation of the project and opened the floor to questions," Stephens says. "We addressed a few concerns, and the community was very supportive of our research endeavors."
The forum was advertised in radio, print, and television, and a few dozen people attended it. Also, it was covered by print and television reporters, who conducted follow-up interviews, Stephens recalls.
"At our site, we had a localized steering committee representative of the general public," he says.
Committee members included local physicians, community leaders, politicians, local clergy, IRB representatives, and local emergency services and fire agency responders, Stephens notes.
Since PAD has been on the market for decades, investigators easily could answer public questions about its safety.
"Anyone in a pulseless rhythm can have the device placed, even if they have a pacemaker," Stephens says.
Also, investigators and clinical trials staff addressed religious objections by training sites to not use the device on people who wear a wristband that identifies them as having signed a do-not-resuscitate (DNR) document, he says.
Of course, each state has different DNR requirements and so this method of identifying people who would want to opt out of the study would be handled differently elsewhere, Stephens adds.
The UAB media office assisted with writing and distributing press releases about the trial, and the UAB clinical trial office ran advertisements in a variety of newspapers, and other media, Stephens says.
"We had a great deal of coverage when the trial began," he says.
A flyer was developed that informed the community of what the trial was, and it was distributed at all of the clinical trial sites, including the control sites, Stephens says.
The flyers contained basic information about the trial, including how long it would take place, who supported it, and contact information for the IRB director, principal investigator, Stephens, and the research team.
"We had another flyer that was circulated through the media relations office to local media outlets about the training for the trial," he says. "And we had media coverage when the devices were placed on sites."
Since the trial was blinded, the clinical trials office could not advertise the lives that were saved by PAD, so all trial updates simply reinformed the public that the trial was ongoing, Stephens says.
"We did have one incident where a local high school that was unaffiliated with UAB and the study had a PAD save," he says. "During that media coverage, we notified the community that there was a nationwide clinical trial currently underway that as looking at automated external defibrillator placement in public."
The UAB clinical trials staff worked closely with the IRB and its director and chair to monitor this process and the study, Stephens says.
"For the first two years, our IRB required quarterly reviews; and after two years, they moved it back to biannual reviews," he says.
"The big thing is to have a close working relationship with the IRB office," Stephens says. "The earlier you can begin those discussions and help to identify the objectives and what the federal government requires and then collectively work toward meeting those requirements, the more efficient and effective the process will be."