2011-03-01

The Society has undertaken numerous advocacy efforts to remove barriers to physician and patient participation in clinical trials. Specifically:

• An ASH-supported provision was included in the health reform law to require health insurance plans to provide coverage for routine costs associated with participation in clinical trials.

• ASH works with Congress to encourage NIH, FDA, CMS, and other federal agencies to collaborate to better harmonize existing policies and regulations on clinical trial operations in order to increase the initiation of new trials and patient access to new treatments.

The ASH policy statement on clinical research and trials (available at www.hematology.org/Advocacy/Policy-Statements/5835.aspx.) proposes recommendations to overcome critical barriers to conducting clinical research, including:

• Lack of harmonization of existing policies and regulations on clinical trial operations

• Insufficient insurance coverage for routine patient care

• Complex consent forms and language

• Inadequate support for benign hematology and rare diseases.