Risk Management



Fraudulent Enrollment of Patient in Clinical Trial

Ryan Bucsi, OMIC Senior Litigation Analyst

Allegation:

Manipulating screening data for study eligibility, failure to supervise technician, and abandonment.

Disposition:

Case settled for $250,000.

Case summary:

An OMIC insured was the principal site investigator (PSI) at an OMIC-insured research center during a clinical trial comparing the effectiveness of an anti-VEGF drug, focal laser photocoagulation, and steroids for the treatment of diabetic macular edema. Enrollment criteria included at least one eye showing definite retinal thickening involving the center of the macula due to diabetic macular edema on clinical exam and OCT central subfield ≥ 250 microns. A technician completed the OCT study; the PSI noted that it was off-center but assumed the subject could not keep her head still. Since the PSI’s exam showed macular edema, the PSI accepted the subject for the trial, obtained informed consent, and proceeded to administer an intravitreal injection of an anti-VEGF medication in the right eye and a sham injection in the left. The patient was instructed to use an antibiotic drop as prophylaxis against infection. Two days later, the patient returned to the PSI complaining of a pressure ache in the right eye and decreased vision. The PSI noted CF vision and diagnosed endophthalmitis, which was treated with a vitreous tap and intravitreal and subconjunctival antibiotic injections. The patient’s condition worsened the next day and surgical intervention was needed. As the patient did not have health insurance, the PSI called the study coordinating center (SCC) to see if it would pay for the treatment. When the PSI learned that no funds were available, the PSI referred the patient to a county facility for further treatment. A culture ultimately grew out a heavy growth of strep viridans. Despite a vitrectomy, the patient was left with LP vision in the right eye.

The insureds reported the adverse event to the SCC. A year later, the research center discovered and fired an employee for embezzlement. One year after that, the SCC conducted a review and noticed a significant number of off-center OCTs, all apparently manipulated or substituted by the fired employee. The research center did its own investigation and clarified to the SCC that it did not offer bonuses for enrolling subjects but suspected that the employee falsified the OCT scans in order to enroll as many subjects as possible as part of her embezzlement scheme. The SCC’s review also concluded, based upon a review of the OCTs and fundus photos, that many of the subjects did not have macular edema, thus calling into question the PSI’s clinical skills. The owner of the research center wrote to all affected subjects. The letter to the injured patient stated that the fired employee had intentionally altered the testing to increase eligibility for the study, that the right eye did not require an injection, and that, if the injection had not been performed, the eye would not have developed an infection. The patient sent a written claim to the research center expressing an intent to file suit.

Analysis

OMIC’s retained expert opined that the claimant did not meet the criteria for either the study or off-label use of the drug. He also felt that the failure of the PSI to obtain a second OCT when the first was clearly off-center was below the standard of care. While the claimant alleged abandonment because the PSI did not provide all care needed for the endophthalmitis, the expert supported the PSI’s management of the complication itself (see Hotline for a discussion of what care must be provided by an investigator). The claimant ultimately accepted a settlement on behalf of the research center for $250,000.

Risk management principles

Ensuring that research subjects meet enrollment criteria protects the research subject, the investigator, and the data. The trial developers in this case built safety into the protocol for enrollment through redundancy: findings of edema were required on both clinical exam and OCT, so either a competent exam or an accurate OCT would have excluded this subject from the trial. A more cautious approach when faced with a questionable test result, such as repeating the OCT scan, may have helped the PSI determine that the patient was not qualified for the study. Improved employee oversight may also have helped the insureds ferret out the fraudulent actions of the employee and uncover the falsification of the OCT scans.

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