Register for FDA asks HHS Inspector General to investigate FDA-sponsored clinical trial
EthicsApril 14, 2003
The U.S. Food and Drug Administration (FDA) has asked the Inspector General of the U.S. Department of Health and Human Services to investigate significant concerns involving a clinical trial that FDA itself sponsored.
The trial, named "Bone 97, A Dietary Strategy to Maximize Bone Mass in U.S. Naval Academy Mid-Shipmen," was funded by the Department of the Army. The principal investigator is an FDA employee, and the coprincipal investigator is employed by a private foundation.
FDA is requesting this investigation because of apparent lapses that occurred during the conduct of this study and failure to safeguard information collected as part of this research which could result in divulging personal medical information in the study files to people not associated with the study. Specifically, FDA's Institutional Review Board (IRB) has found that the principal investigators could not account for the study files of at least 92 of the approximately 260 U.S. Naval Academy midshipmen originally enrolled in the study.
"As the institution of the federal government that oversees the integrity of much of the nation's clinical trials, FDA must be held to the same, if not higher, standards to which we hold others," said Mark B. McClellan, MD, PhD, Commissioner of Food and Drugs. "I am committed to helping assure that all clinical research conducted under our auspices is of the highest scientific caliber and meets every requirement designed to protect patients and their personal information. I am equally committed to ensuring that every effort is made to locate the missing records or to determine what happened to them."
In a letter to Janet Rehnquist, the Inspector General of the U.S. Department of Health and Human Services, McClellan asked that the investigation examine three issues:
* FDA's efforts to locate the missing records and whether more can be done to find them,
* whether FDA's current and planned corrective actions are sufficient to ensure that such problems do not occur again,
* the study's financial management practices and financial integrity
McClellan's letter also noted that FDA's Office of Internal Affairs is conducting a thorough investigation of the problems associated with this study.
The study, which FDA's IRB approved in April 1999, was designed to evaluate the effect of specially formulated nutritional products on the bone mass of the subjects. As part of enrollment, midshipmen completed specific questionnaires and provided additional medical information to the principal investigators. Although participants' names are not included in the missing files, FDA is concerned that the personal identity of study participants can be derived from information in those files. FDA is unaware of any harm to the study participants because of these problems. In addition, FDA has no knowledge that any of the information contained in the study participants' records has been divulged to any person not associated with the study.
Last November 15, the IRB became aware that at least 92 of the participants' files could not be located. On January 15, FDA's IRB asked FDA's bioresearch monitoring inspectors to inspect the study.
In addition to asking the Inspector General to investigate this matter, FDA is separately notifying study participants whose files are affected. FDA has also taken the following actions:
* instructed FDA's principal investigator to end all work on this study
* directed that no papers resulting from this work be published
To help prevent similar events in the future, FDA has begun or will soon start the following corrective actions:
* initiate an inventory audit of all clinical studies sponsored by or involving principal investigators from all FDA centers to ensure that all are being conducted in accordance with departmental and FDA regulations and policies
* require that all FDA centers examine current research monitoring programs and develop specific clinical research quality assurance programs
* make FDA center directors directly accountable for research conducted by their center and its employees
* instruct the IRB representative from FDA's Office of the Chief Counsel to help assure that clinical research reviewed by the FDA IRB is being conducted under the appropriate regulatory scheme for the product being tested
* increase funding for FDA's Office of Science to improve oversight of the agency's clinical research program, including initiating routine outside audits of FDA clinical research
* Establish a mandatory clinical research education and certification program for all FDA clinical investigators and key personnel. This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports.
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