What Advice Do You Have For Preventing Fraud Schemes In Large Phase 3 Studies?

Source: Life Science Leader
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In my experience, this is very uncommon. However, to protect trial integrity at GSK, we employ safeguards reducing the likelihood for such a breach to occur. All study participants are subject to strict control of patient identification (ID), along with the use of unique identifiers. Clinical trial sites are expected to enforce patient identification both for their own records and for the clinical trial files. Any reoccurrence of a unique identifier such as birth date in the same study leads to a flag that triggers review. In other words, being able to enroll in a GSK oncology clinical trial more than once would require the forging of a government-issued ID to escape this process. Fortunately, such situations have not been frequent enough to pose a concern.

DR. AXEL HOOS is SVP, R&D governance chair, and therapeutic area (TA) head for oncology at GSK.