September 2008

Prominent Clinicians Encourage FDA to Validate AD Biomarkers for Use in Clinical Trials

On September 24, 2008, Dr. John Morris, of Washington University St. Louis, Dr. Dennis Selkoe, of Harvard Medical School, and 19 other prominent clinicians sent a letter to the U.S. Food and Drug Administration alerting regulators to a growing consensus in the Alzheimer’s research community that select neuro-imaging and biochemical biomarkers are ready for accelerated validation and use in AD clinical trials.

Having biomarkers included in AD clinical trials would reduce contamination of research samples, improve the safety of patients participating in these trials, and help identify individuals for enrollment in phase III studies. It would also allow exploratory analyses as to whether a biomarker may serve as a surrogate endpoint for demonstrating a treatment’s efficacy.

The letter urges the FDA to play a more proactive role in encouraging the use of biomarkers in clinical trials by engaging in focused discussions with research leaders, patient advocates, and industry representatives to advance this agenda.

To read the letter and to see the full list of endorsements, click here.