William H. Danforth Will Chair Independent Review of Oversight and Monitoring of Clinical Trials at the Institute for Human Gene Therapy at The University of Pennsylvania

PHILADELPHIA --- William H. Danforth, M.D., chancellor emeritus and vice chair of the board of trustees at Washington University in St. Louis, will serve as chair of an independent review panel that will conduct a comprehensive review of oversight and monitoring of clinical trials at the Institute for Human Gene Therapy at the University of Pennsylvania, according to President Judith Rodin.

Dr. Rodin announced her intention to appoint a committee of "...distinguished research scientists with a wealth of academic expertise and relevant experience...." unaffiliated with Penn on Jan. 21, 2000. The committee will report directly to her.

Joining Dr. Danforth on the external review panel are:

  • Joseph B. Martin, M.D., Ph.D., Dean of the Faculty of Medicine, Harvard Medical School;
  • Edward J. Benz, Jr., M.D., Sir William Osler Professor and Director of the Department of Medicine, Johns Hopkins University School of Medicine;
  • Inder Verma, Ph.D., American Cancer Society Professor of Molecular Biology, The Salk Institute, La Jolla, California;
  • Rochelle Hirschhorn, M.D., Professor of Medicine and Cell Biology and Chief of the Division of Medical Genetics, Department of Medicine, New York University School of Medicine;
  • Daniel Callahan, Ph.D., Director of International Programs, The Hastings Center, Garrison, N.Y.

Dr. Rodin said that the committee will have "... a broad mandate to conduct a comprehensive review of every aspect of IHGT procedures for oversight and monitoring of clinical trials."

Specifically, she said, the committee will operate with the following charge:

1. To conduct a thorough, independent review in order to carefully evaluate and assess IHGT's oversight and monitoring of clinical trial programs, with particular emphasis on the FDA's findings about the OTC Therapy Trial and IHGT's response to those findings.

2. To recommend any additional actions necessary to ensure the highest standards are set and met in the conduct, oversight and monitoring of future IHGT clinical trials, including a framework for University monitoring of compliance with these recommendations.

3. To report findings of review to the President of the University of Pennsylvania and recommend issues to be referred to the University's faculty committee charged with reviewing human subject research.

'We intend for our research programs, particularly those involving human subjects, to meet the highest standards," Dr. Rodin said. "Nothing less is acceptable."

Dr. Rodin said that the external review panel is one of two reviews underway at Penn designed "...to achieve this goal and to respond to the important concerns raised by federal regulators." She said that "...we have been and will continue to be strongly committed to cooperating fully with the FDA, NIH, Congress and any other appropriate body as they review these issues."

President Rodin had previously appointed a committee of distinguished members of the Penn faculty, chaired by Provost Robert L. Barchi, to review "...carefully and completely..." all aspects of Penn's research using human volunteers. She said that the unaffiliated scientists reviewing IHGT's supervision of clinical trials will operate independently of the University review of research using human volunteers.