Navigation Links
Clinical Trial Fraud Exposed by Coast IRB
Date:3/11/2009

WASHINGTON, March 11 /PRNewswire/ -- On Friday, March 6, 2009, Coast IRB notified Criminal Fraud unit of the U.S. Department of Justice, the FBI, the FDA, and the Commonwealth of Virginia Department of Health Professions of a fraudulent clinical test. Coast Independent Review Board discovered that a protocol submitted for review of a medical device called Adhesiabloc by Device Med Systems of Clifton, Virginia, was fraudulent in violation of federal and state law. Upon receipt of proof of the fraud, Coast IRB and its CEO, Daniel Dueber, ordered immediate termination of the clinical trial, referred evidence to federal and state authorities for investigation and prosecution, and instituted measures to prevent a recurrence.

Coast IRB has urged authorities to investigate and prosecute the perpetrators whose actual identities remain unknown. Several felony fraud violations and potential RICO may have been committed. "We are informing the media in the hopes of alerting those who might otherwise become study subjects that this appears to be a fraudulent trial," said Coast IRB CEO Daniel Dueber. "We are also doing so because we want other institutional review boards to learn of our experience and avoid review of this trial pending the result of federal and state investigations".

Coast IRB discovered the evidence in a routine audit of the trial. Coast IRB discovered that credentials for the principal investigator were forged and that neither the principal investigator nor the medical director was licensed in Virginia. The Department of Health Professions from whence the forged license was allegedly issued reported no record of granting license to the person involved, no record of the license number listed on the forged credentials, and no issuance of licenses in the history of the Commonwealth in the format presented by the study sponsor. Coast IRB further discovered through on-site visit the address for the clinical trial organization where testing was presumably taking place, was in fact a strip mall. A 510(k) FDA number given for the medical device did not exist in FDA's records.

Coast IRB is one of the largest independently owned IRB's. Its mission is to protect the rights and welfare of subjects in clinical trials by providing ethical and thorough review. It is located in Colorado Springs, Colorado.

    CONTACT:
    Diane Morrow    dmorrow@tbbmedia.com
    800-927-1517


'/>"/>
SOURCE Coast IRB
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Radiologists encouraged to look beyond cancer for clinically unseen diseases
2. Clinical depression linked to abnormal emotional brain circuits
3. Preclinical study suggests organ-transplant drug may aid in lupus fight
4. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
5. Good Clinical Practice Journal Awards: Winners Announced
6. Microsoft Helps Developers of Clinical User Interfaces Improve Efficiency, Patient Safety With Free Toolkit
7. Study Questions Dead-End Cancer Clinical Trials
8. Genomic Health Announces Multiple Studies on Oncotype DX(TM) Presented at 2007 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium
9. Clinical trials present better alternatives for dialysis patients
10. Mirixa Debuts New Clinical Technology Solutions for Enhancing Patient Care
11. IMPACT initiative looks to improve patient participation in clinical trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... that was developed to enhance the health of felines. The formula is all-natural and ... main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are ...
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, ... design, development and manufacturing of collagen and mineral ... announced today that Bill Messer has ... Marketing to further leverage the growing portfolio of ... devices. Bill joins the Collagen Matrix ...
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
Breaking Medicine Technology: