Managing clinical trial fraud

Darshan Kulkarni

Kulkarni law firm

There have been numerous instances of fraud on sponsors in the context of clinical trials. This fraud may be caused by CROs or sites. Despite the impact on sponsors, and potential multi-billion dollar drugs, sponsors continue to be hesitant to discuss fraud within the Industry.

Fraud by sites

There have been numerous instances of fraud by individual sites (examples can be seen here and here). Typically, these instances of fraud are attributed to greed by individual doctors and their clinical staff. While there may be a significant impact on sponsors due to such fraud, this fraud usually only affects an aspect of a clinical trial, which in certain cases may result in a trial’s results being unusable.

CRO fraud

Fraud by a single CRO may result in multiple studies for a single drug to be deemed insufficient. Unlike sites, the impact of CRO fraud may often be significantly further reaching.

"...these instances of fraud are attributed to greed by individual doctors and their clinical staff."

Cetero was a Stage One Clinical Research facility based in Texas. The facility allegedly fraudulently falsified study results. Cetero primarily attributed these fraudulent results to over eager members in the facility who were trying to get overtime and hence mislabeled study results.

Unfortunately, the FDA reviewed the records and noted that it is unable to determine which study results were actually impacted and the extent of the impact. Resultantly, the FDA has warned that it would scrutinize multiple studies that were performed at the Cetero facility. Such actions would have a significant impact on drugs that are in the process of being approved or have already been approved.

Question: How should companies address situations where study results may have been obtained by fraud?

Answer:

Short Answers

A. Plan for fraud / FDA regulatory actions in the Master Services Agreement with the CRO and / or site.

B. Review the exclusion lists for organizations and individuals.

Master services agreements

Most master services agreements tend to be general and address issues like fraud in a non- specific capacity e.g. "this contract shall be deemed void in the case of fraud". Such language is non-specific and does not address what happens in the event of such a "void". A robust contract must, if appropriate, address matters including:

1. What would constitute fraud?

2. What monies must be exchanged in the event of fraud? Options may include:-

• Attorneys fees

• Regulatory filing fees

• Cost of additional testing

• Cost of additional FDA reviews

• A refund of monitoring fees

• etc.

3. Will these fees differ depending on whether the CRO or the site commits the fraud?

"Such actions would have a significant impact on drugs that are in the process of being approved or have already been approved."

Why do these discussions not happen?

Planning a relationship with a potential partner is like planning a marriage between two individuals. Planning and negotiating the agreement often feels like planning the divorce. While it is often prudent to have these discussions, it is difficult to do when planning a long-term relationship. However, doing so is often the smartest way to plan for the future.

Review exclusions and debarments

The FDA continues to maintain lists of individuals who are, either temporarily or permanently, not allowed to participate in clinical studies. The lists have a variety of goals and are hence categorized in multiple ways. The Department of Health and Human Services (HHS) and the Office of Inspector General (OIG) continue to also maintain similar lists for an expansive list of categories. HHS also maintains a more searchable database for simpler searches. It is imperative that Sponsors check against these lists to help avoid the risk of using repeated fraud offenders and hence risking invalidating their own study results.

DISCLAIMER: The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and / or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney-client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.

About the author:

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.