Editorial Examines the Need for Changes in Clinical Trials
Dr. David Knopman, a neurologist with the Mayo Clinic, recently authored an editorial in the journal Neurology calling for a reformation in clinical trial process and outcome measurement for studies involving subjects with mild cognitive impairment (MCI). His article uses a recent trial as an example that showed no evidence of a drug having an effect on MCI. Knopman expressed that with more efficient and meaningful measures of progress, testing, and patient selection, the trial could have shown MCI improvement for patients taking the drug.
Knopman’s editorial in part reflects one of the major goals of ACT-AD-pressing regulators to clarify their policies on the use biomarkers as identification criteria for subjects in clinical trials as well as to qualify them as surrogate endpoints to demonstrate efficacy. In order for patients to gain access to novel Alzheimer’s treatments, change is necessary within the Food and Drug Administration’s (FDA). ACT-AD remains committed to working with clinicians and regulators where appropriate to ensure that regulatory policies are better aligned with current science to improve the development of more effective therapies for all stages of Alzheimer’s disease.
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Congress Acts on FY 2009 Funding for the Food and Drug Administration
An omnibus appropriations bill for FY 2009 was approved by the House of Representatives this week. The current version of the bill contains a $325 million increase from fiscal year 2008 funds for salaries and expenses at the Food and Drug Administration (FDA). It also allows for a $10 million increase in funds for facility maintenance and repairs. ACT-AD appreciates Congress’ continued commitment to providing adequate funding for the FDA. These increases in funds are necessary to ensure that FDA has the resources it needs to adapt to changing science and to properly evaluate new therapies to treat Alzheimer’s disease and many other fatal diseases. Congressional leaders expect to have the bill ready for the President Obama’s signature before the current continuing resolution expires on March 6, 2009.
Task Force Calls for Changes to National Institutes of Health Intramural Research Program
The National Institutes of Health’s (NIH) Intramural Research Program (IRP) provides funding and direction for studies conducted across government health agencies. A task force convened by FasterCures, an ACT-AD member, has made recommendations intended to revamp the IRP’s focus. Among these recommendations, the task force called for greater emphasis on translational, outcomes-based research that better integrates NIH resources with clinical research center. ACT-AD applauds FasterCures’ work with the task force and the overall focus of their recommendations to enhance translational research initiatives in the interest of public health.