Explore the advantages and challenges of decentralized clinical trials (DCTs) in light of the FDA’s new guidance. Learn about digital health technologies, patient engagement, and data management strategies.
FDA Issues New Guidance for the Conduct of DCTs
The Food and Drug Administration (FDA) has recently released new guidance on the conduct of decentralized clinical trials (DCTs). This guidance is intend ed to help sponsors and investigators who are interested in conducting a DCT.
DCTs: These are trials where some or all of the trial-related activities, including informed consent, may be conducted at locations remote from Traditional Clinical Trial Site. This includes using digital health technologies (DHTs) for data entering and managing, and utilizing telehealth to conduct virtual trial participants’ visits.
Existing regulatory guidance on DCTs, summarized by the recent draft from FDA already provides a framework for conducting a DCT with key considerations and how to address them.
Key Specifications & Suggestions on DCTs
Using DHTs to Persist and Query Data
Creating a decentralized-specific safety monitoring plan.
It includes all the stages like collection of data responsibly by using software that is reliable, secure, private and confidential.
The updated requirements and recommendations are intended to protect the safety and well-being of participants in DCTs. They also offer strategies for meeting the specific challenges of DCTs.
Benefits of DCTs
There are several potential advantages to DCTs compared with traditional clinical trials:
Trial participants have more flexibility.
Reduced costs.
Improved flexibility.
Increased efficiency.
Enhanced patient engagement.
Challenges and Drawbacks of DCT are Data protection, regulatory compliance, and managing participant safety.
Conclusion: Navigating the Future of Clinical Trials
In conclusion, sponsors and investigators with interest in running a DCT should read through the new FDA guidance. It discussed the important points to be considered for performing a DCT and also gave general guideline how these should be tackled.
Check out the new FDA guidance for more specifics if you are thinking about running a DCT. The advice is a really useful resource that allows you to plan and run an effective DCT.
This guidance is available from the FDA web site
The FDA’s new guidance on DCTs is a major step forward for this breakthrough methodology of clinical trials. If you are considering a DCT, we would recommend reading the guidance and getting in touch with the FDA for more details.
For all inquiries about the conduct of a DCT, please contact BioBoston Consulting
BioBoston Consulting offers assistance in the following areas:
DCT Protocol Development: BioBoston Consulting can work with you to develop a DCT protocol that will comply with FDA and other agency requirements. And they can help you choose the right DHTs and telehealth platforms too.
Data management and Processing: Assistance with the creation data management plan, incorporation of data entry systems, indexing systems and analysis techniques to ensure quality and security of your data. They can also analyze the data and produce reports for you.
Regulatory compliance – BioBoston Consulting can assist you in making sure your DCT is meeting any and all regulations for which it must comply. They can also assist you in making ready for government inspections.
To learn more about how BioBoston Consulting can assist with your clinical trials, e-mail us today.
