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

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

CRITical Thinking Blog

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.

Read more

What Does a Pro-Patient, Pro-Public Health Regulatory Agency Look Like?

September 13, 2017
By Michael Carome

A pro-patient, pro-public health agenda for the regulation of medical products should, among other things: (a) ensure that these products are safe and effective for their intended uses; (b) maximize transparency regarding regulatory actions and the data used to support those actions; (c) spur the development of new treatments that truly meet the health needs of patients throughout the world; (d) minimize both industry bias in the development of medical products and industry influence on prescribing practices; and (e) ensure that medical products are affordable for all patients who need them and for society.

Read more

Federal “Right to Try” Legislation – perpetuating a misguided skepticism towards the FDA

September 8, 2017
By Jeanie Kim

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

Read more

Patient Advocacy Must Be Rooted in Evidence and Science Literacy to Make a Real Difference

August 31, 2017
By Fran Visco

An informed patient advocacy perspective is vital to ensuring the integrity and transparency of the research enterprise.

Read more

Pages