New recruitment system using patients medical records invites abuse
This is my site Written by Alex on June 20, 2010 – 10:50 am   

As an expert in clinical trials my first reaction when I read the article below in the Wall Street Journal was to say., “What? Is this a joke? Is someone kidding?” But no. Apparently there’s a new initiative to cross reference a patient’s electronic medical records with existing clinical trials that are recruiting. This would allow a doctor to “ask the patient if he or she was interested in participating” in the trial. It doesn’t seem to have occurred to anyone that if your doctor “asks” you to take part in a trial it’s tantamount, for many patients, to the doctor suggesting or recommending that you take part or that you at least seriously consider it. The old fashioned way of a subject seeing a flyer or hearing an ad about the trial and deciding with no influence from a medical professional who may pose a less than objective factor in their decision-making was too cumbersome and  time-consuming.

Nowhere in this article is there any mention of protecting patients from or informing patients about physicians who may have a financial interest in an ongoing trial; either through investment or because drug manufacturers are paying doctors a fee or “bounty” for every subject they recruit into the trial. The potential for conflicts of interest and abuse of patient confidentiality in the name of easy returns for doctors and drug companies is enormous with this new initiative. Anyone who doesn’t recognize that is either willfully ignoring how some trials function or stands to make a profit off the new, streamlined method of going into confidential patient records to recruit subjects into trials,

New Effort Launched for Clinical Drug Trials

By SHIRLEY S. WANG

New York state medical centers and drug makers are launching an initiative to address a nettlesome problem for clinical drug trials: getting patients to sign up.

More than 3,000 clinical trials are actively recruiting in New York state, and an additional 8,000 trials involving New York are already running or were recently completed, according to the government clinical trials registry. Patient recruitment is one of the top reasons that clinical trials are delayed or fail, according to the Tufts Center for the Study of Drug Development.

The new collaboration, known as the Partnership to Advance Clinical electronic Research, or Pacer, aims to create a more systematic way of identifying patients for trials by utilizing the electronic patient medical records that many medical centers already use, according to David Krusch, chairman of the Pacer leadership group and chief medical information officer at Strong Memorial Hospital in Rochester.

Currently, the methods used to enroll patients are “very manual” and “cumbersome,” says Dr. Krusch. Typically, trial operators would recruit patients from a hospital or medical center by hanging fliers in the cafeteria or in waiting rooms. The haphazard method often doesn’t yield the right patients or an adequate number in the needed time frame, according to Dr. Krusch.

Methods for patient recruitment have improved over time with more companies making use of recruitment specialists or patient databases, but “there is a lot of hype,” said Ken Getz, a senior research fellow at the Tufts Center who isn’t involved in the New York collaboration. Sometimes an approach works for one study and not another, he said.

Under the new effort, if a patient meets the inclusion standards for a clinical trial, the system would electronically alert the patient’s doctor. The physician could then ask the patient if he or she was interested in participating. Ultimately, the goal is to link up medical center databases across the region.

“Patients aren’t always aware that opportunities are available,” said Dr. Krusch.

To protect patient confidentiality, only the patient’s doctor would be alerted to the potential eligibility for a trial, and the patient would have to give consent, according to Kathleen Ciccone, executive director of the Healthcare Association of New York State, a nonprofit that represents health-care organizations and hospitals and is part of the Pacer coalition.

The Pacer group also includes the Hastings Center, a nonprofit bioethics group, and several medical centers and health-information technology companies.

The group, which says it receives funding from drug makers and health information-technology firms, hopes to come up with standard protocols for clinical-trial eligibility within the next six to 12 months and start rolling out some of the changes two years after that.

Write to Shirley S. Wang at shirley.wang@wsj.com

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