Clinical Trials Under Scrutiny - Pharmaceutical Executive


Clinical Trials Under Scrutiny
Do you know where your data comes from?

Pharmaceutical Executive

A good way to do that is through the clinical trial agreement (CTA), the formal document describing the research protocol, schedule of events, and all contractual arrangements for PI compensation. Compensation, of course, must pass the fair market value test—regardless of whether the PI's participation is full- or part-time. When lump-sum payments to PIs are involved, it is essential that the CTA define unequivocally the allocation for overhead expenses, administrative or support services, and data collection and analysis, as opposed to medical services and supplies. Clinical trial agreements should also guide community hospitals and PIs to disclose any expenses for which the subject may be responsible once enrolled.

In addition, CTAs need to clarify the disposition of residual funds at the completion of the trial. If there is no clear definition of what to do with the money, PIs will be tempted to keep it for themselves—and perhaps even bill payers for the cost of conducting the clinical trial.

Finally, over the last few years, companies have begun developing ethics offices and other corporate-responsibility positions. These are appropriate channels for companies to use in offering guidance to PIs, but also for investigators who have questions about conflicts of interest. The ethics office is an important place for companies to compile and disseminate that information. And while companies are building these offices, they also need to encourage PIs to access them.

While there are many economic reasons for moving research away from academic centers, companies need to be aware that do so, they also lose the benefits of a well-monitored environment for clinical trials. They take on additional risks—risks that most companies are not managing at this point.

The intensified scrutiny of clinical trials by regulatory agencies, the severity of sanctions imposed for noncompliance, and the ongoing attention of the news media have indeed raised the level of compliance obligation among pharmaceutical companies and the independent physicians who engage in sponsored clinical research. At the same time, these external factors have introduced a new obligation on the part of sponsors and CROs to support, monitor, and, to the extent possible, sustain compliance efforts by participating physician investigators. Such collaborative efforts will lead to properly structured research programs that help clinicians enhance patient care, mitigate risks, and add value to their enterprises.

Timeline: Clinical Trials Gone Bad

Almost every day, the news media report fraud and abuse in the clinical research industry. The following examples show a history of infractions as a result of the lack of oversight by the PI's employer, the sponsors, the CROs, or the site-monitoring organization.

2002: The Department of Justice investigates Biocryst Pharmaceuticals and the University of Alabama-Birmingham for the falsification of clinical research data in a lymphoma study. The physician investigator, who is actually an independent subcontractor from the university, is convicted of the charges; however, the sponsor has to help the PI pay for the settlement because it failed to provide sufficient oversight to prevent the falsification of this data.

2004: After a study coordinator raises concerns about the quality of data supplied by a private physician in Kentucky, subsequent investigations reveal the PI had engaged in apparently fraudulent human-subject-enrollment practices to augment compensation.

2004: Rush University Medical Center agrees to pay $1 million to settle allegations that it billed the government for services provided in connection with clinical trials for which it had been reimbursed by the sponsor.

2005: Gary Kammer, MD, from Wake Forest University School of Medicine, resigns after he is discovered to have created "ghost subjects" in an NIH grant application for systemic lupus research.

2006: Falsification of study data leads to the resignation of Elizabeth Goodwin, PhD, from the University of Wisconsin, with subsequent data retraction and study termination at great costs to the study sponsor.

2006: A PI at the Cleveland Clinic allegedly fails to fully disclose that he received ongoing royalties from a sponsor of his clinical studies. Such a lapse violates the FDA guidance on financial disclosures by clinical investigators, designed to assure the integrity of study data.

Dinh Nguyen is director of compliance consulting with Sinaiko Healthcare Consulting. He can be reached at


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