FDA Warns California PI Over Eligibility Criteria, Case History Maintenance
Failure to adhere to trial eligibility criteria and properly maintain the case histories of trial participants has netted a California-based PI a warning letter from the FDA.
The agency’s October 2022 inspection of Desert Medical Advances, a site that was located in Palm Desert, Calif., at the time of inspection, led to two observations for Maria Greenwald, a rheumatologist in charge of at least three trials at the site.
The first observation outlined in the FDA’s warning letter, failure to ensure trials were conducted according to their investigational plans, centered on a lack of ensuring that patients met all eligibility criteria before being enrolled.
For example, patients were found to be enrolled in two trials simultaneously despite the trials’ eligibility criteria prohibiting concurrent participation, according to the agency. In addition, although eligibility criteria barred patients that used certain medications, patients on these medications were enrolled regardless.
The second observation, failure to maintain adequate and accurate case histories that document all observations and other relevant trial-related data for participants given the trial drug or assigned to a control group, notes instances in which patient case histories did not accurately reflect patient diagnoses and concomitant medications.
“We emphasize that as a clinical investigator, you are responsible for maintaining adequate and accurate case histories. Your failure to maintain adequate and accurate case histories, including your failure to document exclusionary diagnoses and prohibited medications, compromises the validity and integrity of the data generated at your site,” the warning letter notes.
Though Greenwald did address the observations in a written response, saying that the study records were corrected and that her site was initially unaware a participant was enrolled in two trials simultaneously, the FDA did not receive supporting documentation, assurances of corrective actions or a corrective action plan. In addition, the agency noted that “even after you became aware that [the] individual was participating in both studies concurrently, you failed to document … a concomitant medication.”
The warning letter directs Greenwald to address the issues and create procedures that ensure they do not occur again in ongoing or future trials. The FDA has asked that she inform the agency in writing, within 15 business days of receiving the warning letter, of the actions taken at the site to prevent similar violations.
Read the full warning letter here.