By Deb Borfitz
As of this year, Eli Lilly and Company is converting to a new operating model designed to streamline drug development and better “capture the value” of a record-setting number of new medicines in its pipeline…read more
Faced with the challenge of falling success rates in drug development, clinical development teams must find new ways forward. Tessella and Berry Consultants believe that designing smarter clinical trials is part of the solution. We believe that better trial design can help:
• Maximize the impact of your clinical trials on your drug development process.
• Ensure your trial [...]
Yili Pritchett of Abbott was able to show real data from a trial we ran for them between 2007-2009. Read more.
By Parloop A Bhatt
Traditional clinical trials, in which a protocol is designed according to certain assumptions and strictly followed throughout the study, have numerous inefficiencies. Because there is no opportunity for researchers to adapt a protocol to reflect their increasing understanding of a drug as a trial progresses, the outcome may be inconclusive if the [...]
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue [...]
A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is in preparation; this article is an Executive Summary for that full White Paper, and summarizes the findings [...]
Two Drug Information Journal articles on planning and executing response adaptive clinical trials state savings of 2 to 5 months and $1 million to $14 million when using adaptive trials versus using more traditional designs. The Journal’s articles are available on-line: article one - The Process page 710 and article two - Case Studies page 725
- Efficacy and safety data supports advancement to a comparative trial as a strategy to support registration -
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Tessella are proudly sponsoring SMi’s 4th annual conference in Adaptive Designs in Clinical Drug Development. The conference and workshop are being held on February 3rd – 4th 2010, at the Crowne Plaza Hotel, St James, London, UK.
Tessella’s Tom Parke, head of clinical trial solutions, will be presenting Adaptive Trial Design for Oncology Trials on Wednesday [...]
Life Science Leader Magazine – Erie,PA,USA
In 2004, the FDA unveiled a project called the Critical Path Initiative. As then Commissioner of Food and Drugs Andrew C. Von Eschenbach, M.D., later explained to Congress, “This project has the potential to transform the way medical products in the United States are designed, developed, tested, and used.” more
