Specifically, the FDA is interested in how healthcare providers are using consumer-generated data to efficiently conduct clinical research. It also seeks stakeholder perspectives on possible barriers to implementing these technologies and methods to conduct clinical investigations.
“Creative uses of technology in conducting clinical investigations have emerged over the previous decade and include advances that have the potential to improve recruitment, participation and retention of trial participants,” wrote the FDA in its notice.
“Some of these technologies and methods may be used regardless of the trial participant’s location and may include, for example, mHealth technology, telemedicine and remote sensors.”
In addition, the FDA is interested in obtaining information and comment on ways it could encourage adoption of these technologies and innovative methods in the conduct of clinical investigations.
Among the issues being targeted by the FDA are methods for improving consumer engagement in clinical trials, identifying barriers – perceived and real – that keep certain populations from participating, the success or failure rates for different types of technology, specific conditions or populations that benefit from the use of mHealth technology, and methods for ensuring the integrity of data used in the studies.
The notice states that the “FDA is soliciting public input from a broad group of stakeholders regarding technologies and innovative methods for using technology to more efficiently conduct clinical research. The FDA is interested in identifying new opportunities to study medical products, as well as receiving comments on barriers, challenges, and relevant considerations that may affect a medical product clinical investigation that uses these technologies and methods.”
The FDA is also looking into projects that collect data from a number of different devices – calling this the BYOD model for clinical investigations – and efforts made by researchers to connect and work with participants who have little to no computer literacy or limited access to mobile technologies.
Comments are due by 28 December 2015.