FDA Launches Program to Support Clinical Trial Enhancement Tools
The FDA is pilot-testing a new program to develop two to four innovative projects that can help improve remote or decentralized trials or increase the use of wearables in trials.
The Innovative Science and Technology Approaches for New Drugs (ISTAND) program is designed to incentivize trial approaches that don’t fit under the FDA’s existing Drug Development Tools (DDT) program, which qualifies such tools as biomarkers and clinical outcomes assessment.
Just like the DDT program, once a new tool or approach is approved under the ISTAND program, future trials will be able to use it without first applying to the agency for permission.
Examples of ideas the FDA would like to support include using patient-performed digital photography to communicate dermatological developments, artificial intelligence-based algorithms that help evaluate patients, develop novel endpoints or inform trial design, and digital technologies for patient assessment, such as wearable devices.
For information on applying to the program, click here: https://bit.ly/2LMuebR.