An Indianapolis doctor who was studying Pfizer Inc.’s nicotine addiction treatment Chantix enrolled patients last year in a clinical trial who didn’t meet the necessary requirements, and failed to keep accurate records and proper case histories, Food and Drug Administration inspectors say.
The FDA sent a warning letter to Dr. Cassandra Curtis, informing her of “objectionable conditions” at her clinic, following an inspection last year. The letter said Curtis and her staff failed to adhere to the drug’s investigational plan.
Reached by IBJ early Friday afternoon, Curtis declined to comment.
According to the drug’s protocol, patients who participated in the study must have smoked an average of at least 10 cigarettes a day during the past year, as well as during the month before the initial screening visit. In addition, they must have exhaled more than 10 parts per million of carbon monoxide at the screening.
However, Curtis enrolled three patients who did not meet those requirements. One patient smoked an average of six cigarettes per day during the previous month, and another smoked an average of five cigarettes. Yet another had a carbon monoxide reading of 8 parts per million.
In addition, Curtis enrolled a patient with chronic obstructive pulmonary disease, despite a protocol that requires investigators to exclude patients suffering from that disease.
In addition, Curtis or her staff failed to maintain adequate and accurate case histories on several patients, and to record accurate information about dates, quantities and use of the drug by some patients, the FDA said.
“As a clinical investigator, you are required to ensure that your clinical studies are conducted in accordance with the investigational plan,” said the FDA warning letter, which was dated Jan. 27 and placed on the FDA website this week.
It added that the violations “jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site.”
The FDA gave Curtis 15 days to respond, outlining actions she has taken to prevent similar violations in the future, or face unspecified “regulatory action.”
A representative for Pfizer told IBJ that the company through its own monitoring had become aware of "potential data quality issues at this investigator site during the study."
"This led to Pfizer conducting a sensitivity analysis of the main study outcomes to determine if the data from this site had an impact on the overall study results," the representative said. "The analysis confirmed that the overall results were not impacted."