In September 2024, the Food and Drug Administration (FDA) issued its final guidance, 'Conducting Clinical Trials With Decentralized Elements,' providing recommendations for sponsors, investigators, and other interested parties. This guidance aims to clarify and advance the use of decentralized elements in clinical trials, fulfilling a mandate from the Consolidated Appropriations Act, 2023.
Decentralized clinical trials (DCTs) leverage digital health technologies (DHTs), local healthcare visits, and direct shipping of investigational products to participants, enabling remote participation. This approach has the potential to increase access to more representative patient populations and improve trial efficiency, particularly for rural or rare disease populations.
The guidance provides recommendations for DCT design, conduct, and oversight, including the use of local healthcare providers and remote visits, and the implementation of DHTs. Exponent's expertise in digital health, human factors, and regulatory compliance positions it to assist pharmaceutical and medical device companies in designing and executing compliant and effective DCTs.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.