October 26

MedicAlert lifeline lent to patients in drug trials

MedicAlert lifeline lent to patients in drug trials

Thu, 1 May 2003

The Modesto Bee reports that MedicAlert Foundation International which maintains an electronic database of its members’ medical records which are accessible in to treating physicians and paramedics in emergencies, is venturing into the clinical drug trial arena. The company is establishing an arrangement with a Pennsylvania-based Physicians Clinical Research Solutions (PCRS)to include patients who are enrolled in clinical drug trials. PCRS estimates the number of subjects in drug trials in America to be about 1.5 million.

MedicAlert allows patients to communicate instantaneously. This service will enable research subjects to report any adverse effect instantly and confidentially. The service would also provide a safety valve if an emergency arises: treating physicians or paramedics would find out exactly what the person had been taking–thereby avoiding hazardous drug interactions. For clinical trial subjects the service would be paid by the sponsor.

If those maintaining the MedicAlert database, keep a healthy arms length distance from sponsoring drug companies, investigators and institutions conducting clinical trials, this continuous monitoring service may truly provide a much needed safety net for human research subjects.

It could also serve as a reliable database about the actual scope and nature of adverse events occurring in clinical trials– currently that information is kept secret. Ultimately, this may also provide the basis for restoring a measure of integrity to clinical trial reports which suppress negative findings.

Modesto Bee
MedicAlert lifeline lent to patients in drug trials

TURLOCK — MedicAlert, which provides quick access to medical records in emergencies, is taking on a role in clinical drug trials.

The Turlock organization is working with a company in Pennsylvania to sign up people who take experimental medicines under the supervision of researchers.

If a trial participant has a bad reaction or other medical emergency, a paramedic or physician could tap into MedicAlert’s electronic records and see what the person was taking. The information could aid in emergency treatment.

In turn, researchers would promptly learn about a drug reaction — information that could help refine testing.

“There seems to be increased awareness among (drug trial) sponsors to provide additional safety precautions for the participants while they conduct the studies,” said Ramesh Srinivasan. Srinivasan is director of marketing and business development for MedicAlert Foundation International.

The arrangement is with Physicians Clinical Research Solutions Inc. of Wayne, Pa., which helps plan and conduct drug testing with the goal of speeding approval by the federal Food and Drug Administration.

Srinivasan said the arrangement could add 60,000 to 80,000 U.S. members to MedicAlert over five years. The organization has about 2.3 million in the United States and about 1.7 million in other nations, all of them issued bracelets or pendants that identify them to emergency workers.

Tracy Blumenfeld, president and chief executive officer of PCRS, said MedicAlert membership could be provided to 1.5 million or so Americans who take part in drug trials each year.

“Since there’s nothing out there now that has these benefits that we know of, we hope we can get every clinical trial participant using the MedicAlert service,” she said.

Srinivasan said the program eventually could be expanded to drug trials in other countries.

Blumenfeld said trial participants sometimes do not let researchers know of medical problems that happen after the trials begin. The communication with MedicAlert will be “instant and confidential,” she said.

Another goal is preventing emergency workers from administering drugs that, in combination with the trial drugs, could harm the participants.

Drug makers and other sponsors of the trials will cover trial participants’ MedicAlert membership fees while the research is taking place. The participants could remain enrolled at their own expense.

Bee staff writer John Holland can be reached at 667-1227.

Posted on 05/01/03 05:00:15

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