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Integrated Approach Needed for Informed Consent Process in Clinical Trials

Dec 17, 2002
Reuters Health
New York

Data managers and patients would benefit from an integrated, multidisciplinary approach to the informed consent process in clinical trials, according to a report in the December 1st issue of Cancer.

Previous studies indicate that patients remain insufficiently informed despite the adherence to strict informed consent policies, the authors explain, but little research has been done regarding the consent discussions between patients and data managers, those often charged with educating patients about the clinical trials process.

William Loh from University of Sydney, New South Wales, Australia and colleagues conducted four focus groups at three large teaching hospitals in Australia in an effort to identify issues important to data managers actively involved in providing information about clinical trials to patients.

The 21 data managers interviewed identified three roles they considered primary-information provision, quality assurance and patient advocacy, and ongoing support during the clinical trial.

These managers spent considerable time providing information not yet supplied by the physicians, as well as tracking down answers to questions they felt unqualified to answer.

Because of their level of contact with patients and their families, the report indicates, data managers were also able to receive more information about treatment effects and side effects than they might otherwise have obtained.

Data managers noted, however, that problems arose when inconsistent messages were received from different team members; when they felt inadequately trained for certain ethical and legal responsibilities attached to their role; and when confronted with ethical dilemmas that arise in the course of any clinical trial.

"Data managers function within the clinical team," the interviewers note, "and their role will be effective only if appropriate communication with other nursing and medical staff is possible."

"The shortcomings identified reinforce the need for integrated, multidisciplinary research teams with good communication both with patients and with each other," the authors conclude. "Training needs to be targeted at these areas of need to ensure that patients on clinical trials receive the best care."

Cancer 2002;95:2414-2421.

© 2002 Reuters Ltd