This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market.
Journal Editor Calls for ‘Culture Change’ Around Clinical Trial Data
In this STAT article, Ike Swetlitz reports that the editor-in-chief of the NEJM, Dr. Jeffrey Drazen, is arguing that the research community needs to give more credit and recognition to scientists who produce valuable data sets that can be shared with others and analyzed. At a recent NEJM event, patients shared the Dr. Drazen’s sentiment and were surprised that data sharing efforts were controversial among some scientists in the research community.
Drugs That Work In Mice Often Fail When Tried In People
In this NPR article, Richard Harris finds that the reason most new drugs are unsuccessful during human trials is because researchers are erroneously assuming that during pre-clinical testing, animals can simply be seen as “human stand-ins.” Now, scientists like 2016 IACUC and Advancing Ethical Research Conference keynote speaker Joseph Garner of Stanford University, are pushing the research community to embrace and even design for increased variability in animal lab environments and to work harder to understand the biological differences between animals and humans.
U.S. Report Calls for Research Integrity Board
In this Science article, Jeffrey Mervis discusses a National Academies of Sciences, Engineering, and Medicine’s report that recommends scientific societies and academia set up and fund a nongovernmental “Research Integrity Advisory Board” to resolve disagreements and to promote good research conduct. Although the proposed board would not be directly involved in research misconduct investigations or making regulatory changes, the report’s authors believe its focus on improving research ethics would inspire institutions to change their practices.
FDA Approves More Drugs, and Faster, Than Europe, Study Says
Marilynn Marchione reports for the Associated Press that a new study, published in the New England Journal of Medicine, shows that the FDA not only approves more drugs than their European regulatory counterpart, but that their review process is also approximately two to three months faster. The study arrives at a time when the FDA is facing new political pressure to accelerate its approval process; however, experts emphasize that this study and others show that data don’t support the claim that the FDA lags behind other countries when it comes to approving new drugs.