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.

 

Tags

market exclusivity
CCI
FDA
meta-research
patient advocacy
trials
medical evidence
reproducibility
data sharing
Pharmaceutical Marketing
research integrity
YaleCRIT17
payers
regulatory approval
lifecycle evaluation
trial reporting
EMA
right to try
transparency

CRITical Thinking Blog

Appeals Court Rules in Favor of Transparency in Avandia Marketing Suit

May 15, 2019

The United States Court of Appeals for the Third Circuit adopted issued a decision adopting the reasoning advocated in an amicus brief submitted by CRIT.

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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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Postmarketing requirements: Additional transparency may be necessary to strengthen FDA’s lifecycle evaluation process

May 24, 2018
By Joshua D. Wallach, Joseph S. Ross

In the United States, the Food and Drug Administration (FDA) faces a challenging task—striking a balance between allowing promising new drugs to enter the market as quickly as possible and ensuring that they are safe and effective.

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Evaluating the evidence used by the US Food and Drug Administration during the drug approval process

May 18, 2018
By Joshua D. Wallach, Joseph S. Ross

Over the past few years, the US Food and Drug Administration (FDA) has faced continual pressure to accelerate the review and approval of new drugs, in order to promote innovation and provide rapid access to new treatments for patients with serious life-threatening conditions.

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