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

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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Promoting Transparency in Clinical Research

November 3, 2017
By Margaret McCarthy, Jeanie Kim, Joseph S. Ross

Clinical research generates information that is critical to our understanding of medical products. Researchers and pharmaceutical companies conduct clinical studies to see if a promising biomedical discovery can lead to a safe and effective medicine for patients. Investigators start with laboratory testing and preclinical studies that provide basic answers about a treatment’s mechanism. Then, studies involving human participants provide a clearer picture of how the drug, biologic, or device will interact with the human body: Is the drug toxic or safe to use? What is the appropriate dosage?

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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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