Posted 05 April 2017
By Zachary Brennan
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).
Following an inspection at the clinical site between 15 August 2016 and 14 September 2016, FDA says in the letter that Indianapolis-based Cassandra Curtis, MD, failed to adhere to the investigational plan’s protocol requiring certain subjects to be excluded and other requirements on the use of certain medications.
"We are concerned that the majority of corrective actions appear to represent actions taken by American Health Network (AHN) and do not reflect corrective actions that you personally have taken," FDA said. "Although you indicated that on October 3, 2016, you notified AHN that you no longer ‘intend to serve as principal investigator for any future research studies at AHN’ and that you ‘will continue to serve as principal investigator for my only current open study, which is a registry study,’ you did not provide details on how you personally plan to prevent similar violations in any future studies you may conduct at sites other than AHN."
FDA inspectors also found Curtis failed to maintain adequate and accurate case histories, including the failure to adequately document summary diagnosis records, compromising "the validity and integrity of data captured at your site."
In addition, inspectors found discrepancies between the amount of drug given to subjects at study visits, the amount of drug taken and the amount of drug returned for several study subjects.
"Your failure to maintain adequate and accurate drug accountability records, including documents recording drug return, raises significant concerns about the adequacy of your oversight and control of investigational drug, which could impact the validity and integrity of the data at your site," the letter says.