Clinical researcher nets 7-item 483 for improper IRB reports.(Clinical investigators)(Massimo Cristofanilli)

Failure to submit accurate reports to the IRB that reviewed and approved his clinical study resulted in a seven-item 483 to investigator Massimo Cristofanilli, M.D., Houston, TX. FDA inspector Patrick Stone from the Dallas District Office prepared the 483, the only document available at press time.

According to the report, the protocol abstract section titled "Treatment Agent" and in all other study title references, the study drug was improperly identified. Also, Stone wrote: "You erroneously state in protocol section 3.2--Pharmacological Dose, "The physical amount will be [undisclosed], which is a [undisclosed] dose,' when in fact the actual intended and administered dose was [undisclosed]."

Next, the informed consent document used for the investigation did not address all of the required elements of informed consent. For example, FDA documents stated:

"The informed consent document did not describe the risks or discomforts related to [undisclosed] other than [undisclosed]. The ... product used for the clinical investigation was chemical-grade for laboratory use and identified as biohazardous in the Certificate of Analysis you submitted to the IRB."

Also, the document did not disclose appropriate alternative procedures, if any, or specifically state that no alternative procedures existed. Further, the informed consent document did not describe any risks or discomforts related to the infusion of an undisclosed substance and the imaging scan. "It should be noted that in a memorandum dated Jan. 17, 2003, the IRB recommended that you add radiation risks to the informed consent document," the 483 stated.

In a related observation, the report noted that the informed consent document included statements that were not accurate. "The statement, "This study complies with all laws and regulations that apply,' was inaccurate. The study used a new drug ... which required the study to be conducted under an effective IND, [which it was not]."

Further, the clinical investigator did not maintain adequate and accurate study drug accountability records. "Study records show that [undisclosed] vials of [undisclosed] were synthesized and passed on for radio labeling," according to FDA documents.

In addition, Cristofanilli did not follow procedures and requirements governing the use of investigational new drugs. "Specifically, human subjects were infused with [undisclosed], a new drug, without an IND in effect," the FDAer wrote.

The researcher could not be reached for comment.

Massimo Cristofanilli, M.D., Houston, TX, 10/18-22, 11/3/04, Doc. 115347, $3 plus retrieval.

Massimo Cristofanilli, M.D., Houston, TX, Dallas District

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