Data Integrity Issues in Clinical Trials due to Fraud by Patients
[Posted on: Thursday, January 26, 2017]
Most discussions about data integrity revolve around misconduct by sponsors and CROs. An often silent topic is fraud by patients participating in trials. Recently there were reports of extensive fraud by subjects participating in Phase 1 clinical trials in China. Subjects would routinely manipulate biological samples, use fake IDs to get around recruitment restrictions, and lie on the clinical trial forms. The main reason was financial; participation in clinical trials offered significant financial compensation to the participants and acted as an inducement to commit fraud to keep participating in more trials even when it would be medically unsafe. These issues are not limited to China. Similar fraud by patients has been reported in India, Europe and the US. Most regulations and clinical trial ethics requires that a given subject only enroll in one study at a time and have a reasonable gap (usually at least 3-6 months) before participating in a subsequent trial. However absent a reliable way to find out subject clinical trial participation history, it is nearly impossible for sponsors to find out if the subject lies during recruitment and hides other trials that he/she may be currently enrolled in or recently completed. The fraud by patients is more likely in Phase 1 studies with healthy subjects and in bioavailability-bioequivalence studies for generic drugs since they are perceived to be lower risk and require healthy subjects. However, patient fraud in also seen in other trials particularly in drug accountability by patients and patient diaries. Questions have always been raised for financial compensation to subjects in a trial. A simple online search shows many CROs and sponsors offering financial incentives for participation in trials. However, is paying a subject for his/her time really unethical? Most of clinical studies that pay subjects are ones that would be practically impossible without such compensation. It would not be possible to find subjects willing to participate. That is why compensating patients for participating in trials is legal so long as it is approved by IRBs. However, sponsors need to be extra diligent when compensation is high enough to be an inducement for fraud by certain patients even with IRB oversight. The final responsibility for subject safety and data integrity resides with the sponsor even if the subject deliberately lied to the sponsor in the first place. There is a silver lining. Professional patients tend to visit the same clinical trial centers repeatedly within a geographic region, which means that such clinical centers maintain database of subjects for repeat participation. Clinical centers can establish mutually exclusive agreements where every time a subject shows up to participate, they can verify if the same subject is also participating at another center or recently completed another trial. There are concerns for competing centers but it’s likely less worrisome than having an injured subject or unreliable results as was seen at sites in China. If you believe such incidences can only happens in China, you cannot be more wrong.