Clinical trial fraud is not an uncommon problem. Though it is difficult to comprehend, it’s something that should not be ignored.
Despite the problem, there is some hope. According to industry insiders, regulatory scrutiny is starting to ramp up. For example, in 2021 Arun Rao, a U.S. Department of Justice Deputy Assistant Attorney General, announced that identifying clinical trial fraud would be a key area of focus in the coming years.
Some types of clinical trial fraud are straightforward. For example, enrolling participants who don’t meet eligibility requirements. Others are more nuanced, like grant fraud, the practice of misusing government-awarded grant funds.
Regardless of the type of fraud taking place, sponsors need to take steps to prevent it from happening altogether. Luckily, there are several ways to ensure due diligence and significantly reduce the risk of fraud.
Tip 1: Do Thorough Due Diligence Before Hiring a Contract Research Organization (CRO)
Your CRO may be managing most aspects of the trial, but it’s you –– the sponsor –– who is ultimately responsible for how the clinical trial is carried out. Therefore, it’s crucial that you hire an effective CRO with the ability and resources to prevent fraud, particularly if you have multiple trial sites. It may be additionally valuable to engage a third-party vendor oversight firm.
Before contracting with a CRO, take time to do your research. Focus on CRO reputation, ask industry colleagues for references and recommendations and research their quality assurance and oversight practices. Set up interviews with multiple CROs. You may even benefit from partnering with a vendor selection firm to assist in some cases.
Tip 2: Regularly Audit Data and Trial Sites
Most clinical trial fraud occurs in one of two places –– at the physical trial sites or within the data itself. To catch problems in either area, you need to conduct thorough onsite audits as well as comprehensive data reviews.
Schedule these audits at regular intervals and without warning. This ensures you comply with federal rules and requirements, and lets you see what day-to-day operations are truly like.
Regular audits are only part of the equation. You also need to have protocols in place for identifying and addressing issues should you suspect anything fraudulent has occurred. A third-party auditing organization, such as Harbor Clinical, may be contracted to assist in developing an audit plan and conducting site and GxP vendor audits.
Tip 3: Increase Oversight of Decentralized Clinical Trials
During the COVID-19 pandemic, many biopharmas and medical device manufacturers transitioned to decentralized trial models. This protected participants by allowing them to enroll in studies from the comfort of home instead of having to visit trial sites in person.
The advent of remote wearables and in-home monitoring technology have made decentralized clinical trials even more popular. Not only are these studies convenient, but they’re also helping improve patient population diversity and recruitment.
Unfortunately, the decentralized model presents unique oversight challenges. Sponsors need to establish guardrails to prevent fraud. There’s no one-size-fits-all solution, but a mix of good research governance, clear systems for peer review activity, and mechanisms for investigating fraud and unethical behavior is a great launching point.
Preventing Clinical Trial Fraud – Takeaways
Clinical trial fraud is an all too common problem that affects the integrity of scientific and medical advancement. There will always be bad actors, but there are various things that sponsors can do to identify potential issues and subsequently build trust in research.
By taking your time to research and vet CROs, regularly audit data and physical trial sites, and increase oversight of decentralized clinical trials you’re much less likely to encounter fraud.
Need help? At Harbor Clinical we specialize in outsourcing clinical trial services with an emphasis on efficiency, quality, and value. Over the last decade, we’ve worked with dozens of sponsors to bring new drugs and therapeutics to market. Our commitment to open communication, integrity and quality have helped establish our reputation.
We also have a team of GxP auditors who can help you plan, manage, schedule, and conduct site and vendor audits.