Welchol Investigator Gets FDA Warning Letter

Thomas O'Barr, principal investigator with Sestron Clinical Research, failed to keep adequate records, FDA says.

An investigator in a clinical trial of Daiichi Sankyo's diabetes and cholesterol drug Welchol (colesevelam) has been warned by FDA for failing to keep case report forms and other data.

Thomas O'Barr, principal investigator with Sestron Clinical Research, Marietta, Ga., is listed on the NIH clinical trial registry ClinicalTrials.gov as one of the investigators in a currently recruiting, randomized, controlled Phase III study investigating Welchol as add-on therapy to Taekda's Actos (pioglitazone). The aim is to improve glycemic control in subjects with type 2 diabetes not adequately controlled with Actos alone or in combination with either metformin or a sulfonylurea.

The study is being conducted at Sestron and 131 other sites. Details of which study O'Barr was cited for are redacted out of the version of the warning letter FDA posted online Oct. 12, but it does mention patients' blood glucose levels, and the Welchol study is the only one for which O'Barr is listed as an investigator on ClinicalTrials.gov. However, Sestron says on its Web site that it is recruiting for two other diabetes studies.

O'Barr, Daiichi Sankyo and Medpace, the contract research organization listed on ClinicalTrials.gov as the contact for the Welchol study, did not respond to requests for comment.

In its Sept. 30 warning letter to O'Barr, FDA says that during an inspection conducted Sept. 16-30, 2009, the researchers was "unable to provide case report forms ... for any of the 20 subjects screened or 10 subjects enrolled into the study," and that no source documents whatsoever could be found for one subject.

In an Oct. 2, 2009 response to the inspectional observations, O'Barr told FDA he had "counted on the study coordinators to make sure that the source data adequately represented and documented" subject information and that he "clearly should have looked at the records [him]self to ensure that they had been done appropriately."

The agency rejected this response, telling O'Barr that, "as the clinical investigator, it is your ultimate responsibility to ensure that the study was conducted according to the requirements set forth in the investigational plan."

Similarly, FDA found inadequate or conflicting information on various subjects' glucose levels, visual analog scales and clinically significant abnormal lab values. O'Barr responded that he didn't think any of the lab values were abnormal in a clinically significant way, but admitted he lacked documentation to prove this, FDA says.

Finally, FDA found discrepancies in the drug disposition records for the trial. O'Barr attempted to blame this on the study coordinators as well,

but again, FDA said, "As the clinical investigator, it is your responsibility to ensure the maintenance of adequate records of the disposition of the drug."

-Martin Berman-Gorvine ( [email protected] )