Earlier this year, the Food and Drug Administration’s (FDA) Bioresearch Monitoring Program summarized an inspection of principal investigator (PI) Susan P. King-Harris, D.P.M., who was conducting a sponsor-initiated clinical trial involving bunion surgery. Led by the FDA’s Andrace Deyampert, the agency reviewed the principal investigator’s conduct as the sponsor and PI of the clinical trial. After an unsatisfactory response from the PI, the FDA issued a Form 483 (inspection observations) Warning Letter to the Michigan-based podiatrist for conducting a clinical trial without confirming whether the study participants were eligible prior to enrollment. This represents a notable deviation from the investigational plan—in our view—evidence of an aloof behavior that by itself didn’t merit a write up in this media—till we read the excuse and that pushed us over the edge to comment.
The clinical research related to a bunion surgery procedure. The inclusion criteria required patients to have a bunion severity determined by the intermetatarsal angle (IMA), which requires to be between 10 and 15 degrees. Patients with greater than 15 degrees were to be excluded from the study. During the inspection, the FDA inspector found that PI King-Harris failed to perform IMA measurements for all 14 participants enrolled in the study between June 2008 and December 2014. The FDA concluded that exclusion of these critical measurements is a clear failure to evaluate and ensure patients’ eligibility prior to enrollment in a clinical trial.
The FDA reported that King-Harris was operating under their policies and standard operating procedures including 1) Responsibilities of the Principal Investigator and 2) Research Administration Oversight. King-Harris pointed to Beaumont’s quality management system as evidence she was conducting the research in a controlled and compliant location and that specific corrective actions would be expeditiously completed.
The FDA expressed concern that because King-Harris failed to specify corrective actions herself as sponsor and clinical investigator—to prevent similar actions in the future—but rather essentially tried to pass on the responsibility to the health system itself—that the principal investigator was not taking responsibility for her actions.
Beaumont Health, in fact, maintains quality management system, which includes a set of policies and procedures for any investigator conducting research there. These included policies for incidents of noncompliance—with procedures and instructions for mitigation.
King-Harris did conduct her research when she was a medical resident at Botsford Hospital. Botsford Hospital later merged with Oakwood Healthcare and Beaumont Health System. The new system is now known as Beaumont Health.
Now that Botsford is part of Beaumont, any future research conducted at Botsford (which is now renamed Beaumont Hospital, Farmington Hills) will need to be thoroughly reviewed and vetted by Beaumont.
Lack of Experience Doesn’t Get Sympathy
Apparently principal investigator King-Harris declared to the FDA inspectors that the mishap occurred due to 1) a lack of experience as a clinical investigator and 2) lack of exposure to the conduct of clinical trials. At the same time, the PI pointed to the host health systems’ (Beaumont) standard operating procedures and that due to that fact—that they are in place—that the specific incidents would be mitigated. This demonstrates an alarming behavioral trait that seems to become more commonplace in society. On the one hand, engage in an activity where there are clear and demonstrable requirements for participation and, on the other, state that the breach of any material rules is OK because of a lack of experience and understanding—while simultaneously pointing to the parent figure (the health system) that they will fix things. Sound familiar to any parents out there?
When the FDA shows up to the clinic, they expect that the PI and staff are adequately trained on the proper behavior and conduct associated with clinical research. Mistakes are made—own up to them; learn from them and put forth corrective plans to ensure that those mistakes don’t happen again. Quality isn’t so much as following a check-list to cover ones’ proverbial behind—rather it is a state of mind; a value-system that drives individuals to do the right thing.
Call to Action: Sponsors, make sure you carefully vet clinical investigators. There is, of course, the FDA inspection data base as well as other research tools. TrialSite News maintains an investigator database, which includes over 50,000 clinical investigators worldwide.