November 08, 2010

Lupus Foundation of America Announces Groundbreaking Initiatives to Encourage Urgently Needed New Treatments for Lupus

LFA’s platforms will analyze data from previous lupus clinical trials, establish outcome measures, and standardize lupus assessment tools

(Washington, DC) Fifty-two years since the last new drug approval for lupus, the Lupus Foundation of America (LFA) today announced three groundbreaking initiatives that aim to overcome the barriers that have plagued clinical research and the development of new, safe, effective, and more tolerable treatments for lupus, a potentially life-threatening and life-altering autoimmune disease.

Working with key scientific leaders from academia and industry, LFA’s platforms have been developed to help standardize and improve clinical trial design, allowing future studies to be completed more successfully. Improved clinical trials will ultimately lead to the development of an arsenal of new, safe, effective, and more tolerable treatments. From defining what is a lupus flare, to training clinical investigators on lupus assessment tools, to mining of scientific data from previous clinical trials, the LFA‘s goal is to bring lupus under control and improve the quality of life for people living with lupus.

To further expand the medical research effort on lupus and ensure that the development of new lupus therapies continues and grows, the LFA has partnered with key stakeholders to:

Analyze Data from Past Clinical Trials
The LFA is working with partners from industry and the scientific community to collect and analyze data from previous lupus clinical trials. This initiative will provide needed insight on patient response and the challenges with lupus clinical trials.

“This data initiative is an important program and the first of its kind in lupus,” said Jane Salmon, M.D., Collette Kean Research Professor, Hospital for Special Surgery. “Analysis of data from past lupus clinical trials has the potential to provide data which will allow the lupus community and our partners in industry to improve the design of our clinical trials.”

Reach a Consensus Definition of a Lupus Flare
More than 120 international lupus experts from 11 countries have reached a consensus definition of a lupus flare, a period of increased disease activity. A standard definition is a significant achievement in establishing a potential outcome measure to demonstrate efficacy in clinical trials, where previously none existed. The study will be published in the internationally peer-reviewed medical journal Lupus.

Launch Standardized Investigator Training Program
Inconsistencies in training investigators on the use of the instruments to assess disease activity have impacted the outcomes of lupus clinical trials. In response, the LFA developed the LFA Professional Online Instrument Training Program™ (LFA POINT), a web-based training site for researchers and biotechnology companies, as well as investigators and staff participating in multi-center trials.

To read more, please visit our online statement.

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