About this blog

CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

 

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CRITical Thinking Blog

Regulating Medical Products in the Interest of the Public

October 25, 2017
By Alain Alsalhani

There seems to be a deep confidence crisis in the US Food and Drug Administration (FDA) as an institution.

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Regulators Must Act In The Public Interest When Considering Real World Evidence: Examples from TB and HIV Treatments

October 16, 2017
By Marcus Low, Catherine Tomlinson

In general, fears about the potential harms of weakening evidentiary requirements through developments such as the 21st Century Cures Act in the US and so-called adaptive pathways in the EU, are warranted. These legal and regulatory changes increase the likelihood that the public will be exposed to unsafe and/or ineffective medicines. Unfortunately, the deregulation debate is more complicated than this, as shown by three examples relating to tuberculosis (TB) and HIV medicines, which highlight the need for regulatory approaches that allow for consideration of real world evidence when potential benefits outweigh harms.

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Supporting Evidence-Informed Practice By Improving Clinical Research

October 9, 2017
By Rita Banzi

How can we support evidence-informed practice if the vast majority of the research on drugs is flawed?

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Randomized Clinical Trials Will be Needed for the Foreseeable Future

September 26, 2017
By Susan Ellenberg

Platform designs and multi-stage designs do have the potential to increase the efficiency of identifying effective treatments, if not the efficiency of any particular 2-arm comparison, by utilizing a single control group and avoiding the time and administrative burden of opening multiple trials. At a time when new agents are rapidly being developed and coming out of phase 1, platform trials will indeed be an efficient way to prioritize agents for entry into confirmatory efficacy trials.

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