Clinical Trial Fraud: Enrollment, Protocol and Data Integrity
Clinical trial fraud includes enrolling subjects who do not meet eligibility criteria, fabricating visits or data, concealing protocol deviations, and billing Medicare for items the trial sponsor should have covered. Each can support a False Claims Act case where federal money is involved.
Two distinct federal money questions
Trials touch federal funds in two ways. Federally funded research is paid by grant, which raises the grant fraud questions. And Medicare covers routine costs of qualifying clinical trials, which raises billing questions.
Billing Medicare for items the sponsor agreed to provide, or for services in a trial that does not qualify for coverage, is a false claim independent of any research integrity issue.
Where integrity fails
Enrollment pressure is the usual root cause, because site payments are tied to subjects enrolled and retained.
- Enrolling subjects who do not meet inclusion criteria, or concealing exclusion criteria
- Fabricating visits, assessments, or laboratory values
- Backdating consent or conducting procedures before consent
- Failing to report adverse events on the required timeline
- Unreported protocol deviations that affect data integrity
- Billing Medicare for investigational items the sponsor was to supply
Coordinators and monitors see it
Clinical research coordinators run the visits and hold the source documents. Monitors compare source to case report forms for a living. Both are well placed to identify fabrication, and both typically document their concerns in writing before escalating.
Frequently asked questions
Does the trial have to be federally funded?
No. A commercially sponsored trial can still generate false claims if Medicare is billed for routine costs improperly, or if the trial does not meet the qualifying criteria for coverage.
What if the deviation did not affect subject safety?
Safety and payment are separate questions. A deviation that did not harm anyone can still make a claim false if federal money was paid on the strength of protocol compliance.
Who is liable, the site or the sponsor?
Either or both, depending on knowledge. A sponsor that knew a site was fabricating data and continued to fund and use it can be liable alongside the site.
The attorneys who handle these cases
Related reading
Talk to a whistleblower attorney before you report
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