Arnold Ventures has submitted a letter in response to the Food and Drug Administration’s draft guidance on decentralized clinical trials for drugs, biological products, and devices.
The FDA believes that decentralized trials may enhance convenience for trial participants, reduce the burden on caregivers, and increase clinical trial enrollment among populations with limited access to traditional trial sites. This will help improve the engagement, recruitment, enrollment, and retention of a study population that could reflect the patient population that may ultimately use the product.
However, in order to ensure strong approval standards by the FDA, AV recommends that decentralized trials take into account particular considerations when designed, conducted, and monitored, such as:
- Defining which medical products are most likely to benefit from this approach;
- Delineating specific patient health outcomes where the decentralized trials approach provides more accurate or less error-prone outcome assessment; and
- Designing data collection that is consistent and standardized across trial sites.
For more information, read our entire letter here.