What is going on with Duke? Last year the U.S. National Institutes of Health (NIH) suspended seven grants to Duke University following “allegations of research misconduct…and…potential issues concerning clinical research irregularities, now exposed due to a letter from NIH to Duke. Follow the link below to the actual letter from the NIH to Duke.
TrialSite News covered Duke’s recently settled a whistleblower case with the U.S. government alleging scientific misconduct for $112.5 million. The next reported issues involve a different department.
In March 2018 the NIH sent a letter citing a previous letter that Duke had sent to the NIH in December 2017 in which the university disclosed allegations of misconduct against Duke investigators within the psychiatry department as well as clinical research irregularities.
The March 18 letter stated:
“Due to a lack of details concerning patient and welfare and safety and with no further communications from Duke, in a letter dated January 31, 2018, NIH asked Duke to respond to NIH’s overarching concern for the welfare and safety of research participants as well as several pertinent questions concerning the reported research irregularities,”
Apparently according to a letter sent to the Duke Chronicle the grants have been reinstated with no findings of research misconduct during an investigation in response to the “anonymous allegations” noted Michael Schoenfeld, Duke’s vice president of public affairs and government relations.
The Chronicle reports that this unfortunately is starting to represent a pattern of potential misconduct allegations the universities has been subjected to over the past decade. They include the following:
- March 2018 the NIH placed restrictions on Duke demanding that researchers seeking grants to submit detailed budgets as well as seek NIH approval when carrying unused research funds to the next budget period.
- In March TrialSite News reported that Duke had paid the federal government $112.5 million to settle litigation that accused Duke secured $200 million in research grants based on faulty, doctored data.
- In 2015, Joseph Thomas, a former lab analyst filed a legal claim under the False Claims ACT, alleging that the University utilized falsified data to secure grant funds. What was this about? Apparently Erin Potts-Kant, a pulmonary, allergy and critical care development researcher, had 16 papers retracted after the data she compiled was challenged.
- In 2015 Anil Potti, a former Duke cancer investigator, faked research on how a patient’s genes predict and impact a patient’s ability to respond to cancer drugs and the probability of relapse, based on a report from the federal Office of Research Integrity. This report declared that Potti’s data was utilized to form the basis for clinical research. TrialSite News includes the report here.
Root Cause & Corrective Action
- Duke has undertaken a range of measure to improve research integrity. This includes the following:
- The appointment of Geeta Swamy as associate vice provost and vice dean for scientific integrity
- The creation of an advisory panel on research integrity and Excellence
- Mandatory research conduct training and improvements in clinical research oversight through the Clinical Quality Management Program
TrialSite News doesn’t doubt the authenticity of the accountability and responsibility its leadership has expressed in light of these findings over the past few years. The Duke leadership undoubtedly maintains the highest of expectations and standards for clinical research grant awardees.
But undoubtedly there has been a breakdown within the various departments and divisions of clinical research at some level. Clearly at least some clinical researchers have succumbed to considerable pressure to take materially questionable short cuts. Organizations lose track of why they are conducting research in the first place. Should leadership establish financial goals for research units, challenges within departments can ensue. We have already placed Duke on TrialSite News’ Site Watch to monitor progress.
TrialSite News contributor Larry Kennedy wrote an important perspective on “Is Bureaucracy Strangling Clinical Research? A Quality Guru Chimes in.” In highlighting some of the challenges in clinical research Kennedy reminded the reader about a quote from Dr. Greg Koski, founder and CEO of the Alliance for Clinical Research Excellence & Safety (ACRES) in which the prominent investigator noted “we’ve striven to achieve a culture of compliance, but we more certainly needs is a culture of competence and conscience that will take us beyond meaningless metrics, inspections, document reviews, checklists, monitors and the repeated calls for doing better that have been repeatedly offered in the kabuki theatre of clinical research improvement.”
Profound words with important considerations for Duke as they apply their “Clinical Quality Management Program” in pursuit of “fixing” a few bad actors from the past. Perhaps there is a deeper systemic flaw that merits a more fundamental look at vision, mission and purpose.