FDA is soliciting input from a broad group of stakeholders on the use of technologies and other innovative methods to conduct clinical trials. FDA faces challenges in recruiting and retaining sufficient numbers of trial participants to conduct a trial in a reasonable amount of time. This can contribute to the cost and complexity when conducting trials.
FDA is looking for new technologies and communication infrastructure to collect data wherever the trial participant is located in order to obtain data more frequently. This would make it possible for the sponsor of the trial to better understand the safety and effectiveness of drugs, biologics, and medical devices. This would also increase additional meaningful data gathering, minimize missing data, and maximize trial participation and retention.
The technologies and methods used may include mobile health technology, telemedicine, and remote sensors. Online web-based eligibility screening, informed consent, and communication between investigators and participants may also contribute to the success of clinical trials.
FDA is specifically interested in comments from stakeholders on:
- Technologies, communication infrastructure or innovative methods that are currently used to do clinical investigations
- Challenges that stakeholders anticipate when adopting new technologies or methods
- Potential trial participant acceptance of the technology related to privacy
- Specific patient groups or therapeutic areas that could benefit from new technologies or methods being used
Go to https://federalregister.gov/a/2015-27581 for more details. For more information, contact Nicloe Silva, at the Center for Drug Evaluation and Research (CDER) at 301-796-3419. Comments must be submitted by December 28, 2015.