Should an Institution That Has Commercial Rights in a New Drug or Device Be Allowed to Evaluate the Technology 英文参考文献.docVIP

Open access, freely available online The PLoS Medicine Debate Should an Institution That Has Commercial Rights in a New Drug or Device Be Allowed to Evaluate the Technology? Ross McKinney, David Korn B passage of the Bayh–Dole Act in 1980 encouraged ackground to the debate: In the United States, the universities to license inventions for commercial development. Although this ?nancial incentive can stimulate academic researchers to discover new drugs and devices, there is concern that the possibility of monetary reward could distort investigators’ objectivity. Ross McKinney’s Viewpoint: Universities Should Be Allowed, Provided the Trial Is Approved by an External Review Board One of the principal missions of an academic health center is to advance the understanding and treatment of disease through clinical research. In this pursuit, there is a need for checks and balances. When Jesse Gelsinger, a relatively healthy young adult, died in Philadelphia during a clinical trial of a novel adenovirus-based genetic therapy for ornithine transcarbamylase de?ciency, it was a tragedy [1]. In retrospect, there were many clues that there were problems with the adenovirus vector, clues that neither the investigator nor the institution pursued. DOI: 10.1371/journal.pmed.0020009.g001 The PLoS Medicine Debate discusses important but controversial issues in clinical practice, public health policy, or health in general. An external IRB could provide independent oversight of the trial (Illustration: Giovanni Maki) PLoS Medicine | 0005 January 2005 | Volume 2 | Issue 1 | e23 | e9  Attorney Alan Milstein made the case that the investigator and institution were both blinded to these problems by their heavy ?nancial investment in the technology, an investment worth millions of dollars [2]. Though the legal case was settled out of court, it created a de facto standard that institutions with commercial rights in a new drug or technology should not be allowed to pursue clini