New FDA Guidance Provides Recommendations for Conducting Decentralized Clinical Trials
The Food and Drug Administration (FDA) has recently released new guidance on the conduct of decentralized clinical trials (DCTs). This guidance provides recommendations for sponsors and investigators who are considering conducting a DCT.
DCTs are clinical trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. This can include the use of digital health technologies (DHTs) to collect and manage data, as well as the use of telehealth to conduct remote visits with trial participants.
The new guidance from the FDA highlights the key considerations for conducting a DCT and provides recommendations on how to address these considerations.
Here are some of the key requirements and recommendations for DCTs:
The use of DHTs to collect and manage data.
The development of a safety monitoring plan that is specific to the decentralized nature of a DCT.
The ensuring that data collected using software is reliable, secure, private, and confidential.
These new requirements and recommendations are designed to help ensure the safety and integrity of DCTs. They also provide guidance on how to address the unique challenges associated with DCTs.
Benefits of DCTs
DCTs offer a number of potential benefits over traditional clinical trials, including:
Increased convenience for trial participants.
Enhanced patient engagement.
Challenges of DCTs
DCTs also pose some challenges, including:
The need for robust data management systems.
The potential for security and privacy concerns.
The need for careful planning and execution.
The new FDA guidance provides a valuable resource for sponsors and investigators who are considering conducting a DCT. The guidance highlights the key considerations for conducting a DCT and provides recommendations on how to address these considerations.
If you are considering conducting a DCT, we encourage you to review the new guidance from the FDA. The guidance is a valuable resource that can help you plan and conduct a successful DCT.
Link to FDA guidance document: https://www.fda.gov/media/167696/download
The FDA's new guidance on DCTs is a significant step forward in the development of this innovative approach to clinical trials. If you are interested in conducting a DCT, I encourage you to review the guidance and to contact the FDA for additional information.
If you are interested in learning more about conducting a DCT, please contact BioBoston Consulting at www.biobostonconsulting.com or by calling or texting 1-617-275-2418.
BioBoston Consulting can help you with the following:
Planning and conducting a DCT: BioBoston Consulting can help you develop a DCT protocol that meets the requirements of the FDA and other regulatory agencies. They can also help you select the appropriate DHTs and telehealth platforms.
Data management and analysis: BioBoston Consulting can help you develop a data management plan and implement a data management system that ensures the accuracy and security of your data. They can also help you analyze your data and generate reports.
Regulatory compliance: BioBoston Consulting can help you ensure that your DCT complies with all applicable regulations. They can also help you prepare for inspections by regulatory agencies.
If you are interested in learning more about how BioBoston Consulting can help you with your clinical trials, please contact us today.