Improving Equity and Access to Health Care: How Nontraditional Organizations Can Help Increase Clinical Trial Diversity
As part of the American Diabetes Association’s health equity work, the ADA crafted a Health Equity Bill of Rights, a set of ten principles that continue to guide ongoing efforts to tackle systemic barriers to health and health care in the United States today. This paper will focus on the ADA’s efforts around the sixth principle, “The right to participate in clinical trials without fear.” Too often, the communities that most need the drug or medical product are excluded from clinical trial participation, potentially hindering the ability to gauge efficacy and safety. Read the paper.
Digital Technology-Enabled Care Models for Diabetes: A framework for developing quality standards and measures.
Diabetes is on the rise—and so are the numbers of apps, sensors and software created to help people manage the disease. Some are regulated by the FDA, others are not. Many lack high-quality clinical trial evidence of their efficacy. As a result, it can be difficult for patients and health care professionals to make informed decisions about how and which technologies to use as part of a care plan. The American Diabetes Association and the National Committee for Quality Assurance are taking steps toward creating the first-ever quality standards for diabetes digital technologies (DDT), as outlined in a this whitepaper. The paper draws on expertise from federal and state government officials, clinicians, digital therapeutics experts, academics, policy makers, and technology innovators. It defines categories for DDTs, criteria for assessing the categories, and lays out next steps to map the DDT assessment criteria to future standards and/or accreditation programs. Read the paper.