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.


CRITical Thinking Blog

Prospective registration among trials published in specialty society journals: We can do more to promote transparency and research integrity

August 23, 2018
By Joshua D. Wallach, Anand D. Gopal, Joseph S. Ross

In order to improve the integrity and transparency of medical research, there has been a growing movement toward prospective clinical trial registration.

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Federal Judge Rules in FDA's Favor in Dispute Over Pediatric Exclusivity: A Win for the Agency, Patients, and Clinical Evidence

February 21, 2018
By Jeanie Kim, Amy Kapczynski, Joseph S. Ross

On February 17, 2018, a federal judge in the D.C. District Court affirmed the U.S. Food and Drug Administration's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster drug cinacalcet (Sensipar).

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Seven Thoughts on the History and Present Practices of the FDA and Uses of Prescription Drugs

January 31, 2018
By Donald W. Light, Joel Lexchin

From before 1906, when the Pure Food and Drugs Act was passed, through the Vioxx crisis in 2004 to today, organized pharmaceutical lobbying has consistently tried to undermine Congressional efforts to protect patients from unsafe and ineffective drugs, often with considerable success.

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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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