How Doctors Can Avoid Getting Caught Up in Pharmaceutical Clinical Research Trial Fraud

Pharmaceutical clinical research trial fraud has been a major focus of the federal government in recent years. Before a new drug can be prescribed to the general public, the U.S. Food and Drug Administration (FDA) requires that clinical research trials be conducted on human subjects to determine the efficacy of the drug in treating a medical condition, and if it poses a risk of serious side effects. The facilities which conduct the testing are called clinical research laboratories. Unfortunately, some of the facility owners and employees fail to follow the FDA regulations and guidelines for conducting these studies, which results in inaccurate or outright fraudulent data being submitted, which poses a threat to the public. 

The majority of clinical research trials require that a licensed medical doctor act as the principal investigator and oversee the study. Unfortunately, medical professionals may unknowingly be participating in a fraudulent scheme by relying on owners and employees of the research facilities to conduct portions of the study, but don’t engage in the necessary oversight. For example, when a principal investigator delegates the screening of the human test subjects, individuals who do not qualify to participate in the study may be allowed in. This can lead to falsified data being created and submitted to the pharmaceutical companies which rely on the accuracy of the test results. Nevertheless, the ultimate responsibility  to insure the integrity of the study remains on the principal investigator. Failing to uphold that duty can result in criminal charges, potential loss of your professional license, significant fines, and even prison.

Don’t Delegate Tasks Which Are Your Responsibility

Many doctors acting as principal investigators also have their own medical practices. The demands placed upon them may result in the doctors inability to focus on the study and delegate tasks to employees of the research facility who do not follow the required protocols and commit fraudulent acts.  The research facilities are compensated well for conducting the studies, so they will often attempt to lull the principal investigators into a false sense of security by promising to meet with the subjects, collect all the data, fill out the necessary reports, and do the work that is actually the responsibility of the doctor. Odds are there are no licensed medical professionals on site and the facility is instead falsifying data and using subjects who would otherwise be ineligible to participate in the trial.

Fulfill Your Duties as a Medical Professional

As noted above, the facilities will often try to convince the principal investigator that the proper protocol is being followed during the trial. This is a recipe for disaster! Principal investigators need to be involved  by meeting with the subjects (as is required by the law), assessing whether or not they’re eligible for the trial, discussing informed consent with each subject, reviewing the 

data, noting any side effects and adverse effects of the drug and making sure that accurate test data is provided to the pharmaceutical companies. 

One of the tasks which may typically be delegated is the actual administration of the drug. The doctor does not have to be at the facility giving patients the drug, but the rest of the responsibilities required by law must be fulfilled by the principal investigator and only the principal investigator. Signing reports and charts that they have not reviewed and allowing falsified data to be submitted could be devastating to a doctor’s professional career, reputation and freedom.

Rely on an Experienced Defense Attorney to Protect Your Work and Your Freedom

Participation in pharmaceutical clinical research trial fraud can result in severe consequences, ranging from administrative discipline against a professional license and fines,  to criminal prosecution. If you are being investigated or prosecuted for clinical research trial fraud your best course of action is to contact a pharmaceutical clinical research fraud defense attorney who understands the law in this area and can implement an effective strategy on your behalf.

Barry M. Wax, Attorney at Law, is dedicated to defending the licenses and rights of medical professionals  across the United States. If you find yourself under federal or local investigation for pharmaceutical clinical trial fraud, contact our firm right away. We are here to defend your rights when confronted with these allegations.