The NIH has a notice about a proposed rule that “clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database.” Comments are due on or before February 19, 2015. We may ask the NIH to consider expanding the trials registry to include more information on the economics of clinical trials.
Here is a link to the Regulations.Gov docket for the proposed rule:
http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003 Continue Reading
On November 24, 2014. the Union for Affordable Cancer Treatment (UACT) sent a letter to Anthony P. Monaco, Office of the President, Tufts University, with copies to Michael Baenen, the Tufts Chief of Staff, and Peter Dolan, Chairman of the Board of Trustees for Tufts University, regarding the Tufts University press conference to announce an estimate of $2.6 billion as the R&D costs for new drugs. Continue Reading
Leading up to the release of Professor Joe DiMasi’s latest study of the cost of drug development, KEI offered $50 to the individual who could most accurately predict the new cost for drug R&D.
We received 26 guesses, ranging from $1.157 billion to $5 billion.
Joel Lexchin’s estimate ($2.47 billion) was the closest to DiMasi’s number ($2.558 billion). It was also the 5th largest estimate.
A complete list of submissions is below.
Name & Guess
Charles Clift – 1.157 billion
Nicole H – 1.2 billion
Ronald Rader – 1.55 billion
Wouter Deelder – 1.655 billion
The Tuft Center for Study of Drug Development (CSDD) has just concluded a press conference, and issued a press release about their new study of drug development costs. The key number is $2.558 billion.
When the new Tufts study on the costs of R&D for development of a new drug is released Tuesday at 10AM, here are 10 things to look for:
We will be sharing some data on 2005 to 2014 oncology approvals, including the size of the trials cited in the medical review, and the orphan status.
The spreadsheet we are working on updating is published here:
A copy of the research note is also available here as a pdf file: /wp-content/uploads/kei-rn-2014-3.pdf
KEI Research Note 2014:3
Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
November 17, 2014
On 14 March 2014, KEI published “Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules” in which we provided an analysis of the Global Fund’s plans to create a global framework for tiered pricing enforced by the rules of the World Trade Organization (WTO). Continue Reading
The following intervention on patents and health was delivered by KEI during the 21st session on WIPO’s Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.
Statement of Knowledge Ecology International (KEI)
Item 7: Patents and health