Are Humanitarian Use Devices studies eligible for accrual under Standard 1.9?

Humanitarian Use Devices (HUDs) are medical devices that are intended to benefit patients by treating, diagnosing, or preventing diseases or conditions affecting fewer than 8,000 individuals in the United States per year. According to the Commission on Cancer (CoC) Standards, studies involving HUDs typically do not qualify for accrual under Standard 1.9.

Standard 1.9 focuses on the eligibility criteria for clinical trials and the types of studies that can accrue patients. The primary aim of this standard is to ensure that participating studies contribute valuable data to improve care and inform future research. Given that HUDs are specifically designed for very rare conditions and often lack robust data on their safety and effectiveness, they generally do not align with the broader goals of Standard 1.9 regarding accruing patients to studies that can produce reliable outcomes applicable to larger populations.

Therefore, studies involving humanitarion use devices are not included under the accrual requirements set forth in Standard 1.9.