Trial subjects have emergency help
MedicAlert charms warn docs of participation
What would happen if one of your clinical trial participants appeared in an emergency department (ED)? How would physicians know the potential impacts of study medications on their treatment? How could they know whether the patient was having an adverse reaction to the study medication or some other problem?
Now there is help available. RapidTrials, a clinical trial accelerator firm has linked with MedicAlert Foundation to provide emergency medical information services for study subjects.
There are an estimated 1.5 million such participants in the United States, about 15,000 of whom will show up in an ED as a result of a serious adverse event (SAE). Others may appear in an emergency department for other reasons, unable at the time to even disclose they are part of a research protocol.
According to Tracy Blumenfeld, MBA, president and chief executive officer of RapidTrials, some 80 people a year die as a result of a drug used in a clinical trial. Some of those deaths may well be because they show up in an ED and either can’t tell the physicians about the trial they are in, or don’t have information available to them that could assist that doctor.
Under the new program, RapidTrials will offer customized MedicAlert membership benefits to study subjects. The national program will be made available through participating sponsors and research sites conducting clinical trials in the pharmaceutical, medical device, and biotech sectors.
MedicAlert’s emergency medical information service, featuring 24/7 live response, will be provided to each subject through the duration of a study.
Upon enrollment, study subjects will register with MedicAlert and be provided with a personalized bracelet or necklace bearing a coded serial number linked to their particular study. In the event of a medical emergency, first responders can call the MedicAlert 24-hour Emergency Response Center and have access to each subject’s electronically stored medical record. The confidential records will include a patient’s vital health information, contact information for the principal investigator of the study, and any study-specific medical details.
The goals are twofold, says Blumenfeld. First, due to the nature of blinded clinical trials, emergency responders are often unaware of risks posed by unforeseen drug interactions or medical interventions they may give to study patients. In addition, the program can lead to quicker approval processes for medications being studied by making sure that safety data is complete, she says. "Look at the drugs that have been recalled recently because they didn’t have the total picture on safety. If we can get more information in a more timely manner, we can speed things up."
The cost, covered by the sponsoring company or institution, depends on the length of the study and the number of participants, but is generally about $100 per participant, says Blumenfeld. So far, there are several studies have signed up their patients, including one study with more than 300 subjects. As of press time, there had been no incidents of a subject needing to use the system. But says Blumenfeld, that’s a good thing, since in the best of worlds it wouldn’t be used at all.
"This offers a safety net," she says. "We work with about 600 study sites on a regular basis. We kept hearing that SAEs are an issue, that they don’t hear about them in a timely manner, or they don’t hear about them at all. We were trying to come up with ideas to help them get more information on a timely basis. MedicAlert was a natural."
Source
For more information on the program, visit the MedicAlert web site at www.medicalert.com, or the RapidTrials site at www.rapidtrials.com.
• Traci Blumenfeld, MBA, President and CEO, Rapid Trials, 1008 Upper Gulph Road, Suite 100, Wayne, PA 19087.
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