The success of a clinical trial relies on the integrity of the sponsors, vendors and other key decision-makers. While it would be nice to assume that all players uphold moral standards- particularly in an industry where the wellbeing of human subjects and cures for life-threatening ailments are at stake – unfortunately, that isn’t always realistic.
Case in point, the Department of Justice’s recent sentencing of two Florida-based CRO study coordinators to more than two years of prison each. According to EndPointsNews, the accused:
“entered false information in the case histories of subjects to make it appear as if the subjects were eligible for a trial, or they recruited patients into trials who were not eligible, and obtained personally identifiable information from third parties to enroll patients without their knowledge or consent…Three others affiliated with Tellus have previously pled guilty and are currently in prison after the scheme was uncovered.”
Unfortunately, this anecdote isn’t an isolated event. Over the last few years, there have been similar stories globally.
For example, in May, The French Medicines Agency filed charges against a local research institute for “serious breaches” that “might qualify as criminal,” and a recent analysis of trial manuscripts submitted to the journal Anesthesia, found that “upwards of 40% probably contained false patient data.”
Narratives like these are disheartening. But they also emphasize the necessity of quality control. Without systems in place to manage trial sites and monitor data collection, you run the risk of lawsuits and FDA regulatory enforcement, not to mention criminal prosecution.
Even so, fraud and misconduct don’t have to be part of the equation. If you understand where fraud is most likely to occur and select qualified vendors, you can avoid problems and stay within the confines of the law.
Scientific Fraud and Misconduct – Understanding the Differences
The Oxford English Dictionary defines fraud as “wrongful or criminal deception intended to result in financial or personal gain.”
In scientific research, that deception takes on different forms, including:
Intentionally falsifying or fabricating research data
Misleading reporting of the scientific results
Failure to follow established protocols, unduly influencing results
Fraud and misconduct are often mentioned together, but they aren’t the same thing:
Fraud is deliberately deceitful. For example, telling a lie.
Misconduct isn’t intentional, but instead, an act of poor management. Good Clinical Practice (GCP) guidelines were developed, in part, to help prevent misconduct in clinical studies.
Clinical Trial Fraud and Misconduct: Why Are They Such Problems?
There are several reasons clinical trial fraud and misconduct are growing problems. Let’s take a look at the three culprits that industry experts commonly cite:
1) Many trials struggle to find patients. 80% of clinical trials miss their enrollment deadlines and more than 30% of patients drop out. Many trial sponsors are so desperate to find qualified candidates, fraud prevention just isn’t a priority.
2) The structure of clinical trials. Data review occurs throughout the clinical trial process. If fraud isn’t caught early on, it can go undetected for weeks, months, or even years.
3) The internal politics at trial sites. For a clinical trial to succeed, sponsors and CRAs must build positive relationships with the administrators at each trial site.
It’s important you do your due diligence, making time to regularly check in, but you don’t want to be overbearing either. If there’s a lack of trust or respect between parties, it can negatively affect communication, data accuracy, and trial enrollment.
Prevent Fraud and Misconduct with Vendor Oversight and Site Selection
We aren’t sharing this information about fraud and misconduct as a scare tactic, but it’s crucial to be aware of these issues so you can put practices in place to prevent them from occurring. One way you can significantly reduce your risk or even prevent fraudulent activity from occurring is by partnering with a qualified vendor oversight organization.
At Harbor Clinical, we regularly provide vendor oversight and site selection services to help mitigate fraud and misconduct. Our capabilities include:
1) Cutting-edge technology
We regularly partner with technology vendors, like CluePoints, to provide remote monitoring services with an emphasis on fraud detection. The software uses an ICH and FDA-advocated approach to manage risk for the entire clinical trial lifecycle.
2) Experts trained in identifying fraud and misconduct
One CRA can’t do everything, which is why we assign each of our partners several. These specialists are trained in the key elements of fraud detection and know how to spot:
False identifiers (i.e. dates of birth, or visit/test dates)
Inconsistent source documentation practices
Inaccurate data entry
If we uncover anything unusual at any phase of the trial, we alert your team immediately.
3) Help with data entry
Data entry is one of the most important aspects of clinical research, but the numbers have to be accurate. Our vendor oversight program provides trial sponsors with a dedicated data entry specialist. These individuals have direct access to your patients and serve as an independent source of data entry.
4) Training to spot fraud prevention
Identifying clinical trial fraud can be difficult, especially if you don’t know what to look for. Our vendor oversight experts can teach you and your project team how to identify fraud and misconduct in the earliest stages. They can even help you establish a system of checks and balances, ensuring your patients are safe and the data collected is accurate.
Fraud & Misconduct – The Importance of Proper Oversight – Takeaways
Vendor selection and oversight are essential in protecting the integrity of clinical research. If you’re planning to launch a new trial in the coming months, now is the perfect time to implement an oversight program.
Partnering with a vendor oversight organization can save you money, help you stay compliant, and reduce the risk of misconduct and fraudulent activity in your clinical trials. To learn more about how we can help, contact us at [email protected].