On October 29, 2015, FDA issued a notice requesting comments on the use of new technologies – such as smart phones, tablets, and wearable technology – to recruit for and conduct drug clinical trials.1 FDA is soliciting input from industry on experiences with the use of these new technologies, communication infrastructure, and innovative methods in efficiently conducting clinical trial research, as well as on possible barriers to implementation of these new approaches.
FDA recognizes that challenges in recruiting sufficient numbers of participants, along with geographic and logistical barriers, often impede the efficient and successful conduct of clinical investigations. In that regard, certain more recent technologies may help improve recruitment and retention of participants, for example by providing convenience to participants, allowing for long-distance participation, and remote monitoring. New technologies may also allow sponsors to more frequently and efficiently collect data. Examples of relevant technologies include mobile health products, telemedicine, and remote sensors, as well as recruitment methods like online eligibility screening, informed consent, and investigator-participant communication.
To better understand the potential benefits and barriers of these new technologies and to identify new opportunities to study medical products, FDA is requesting comment on multiple issues, including:
- The benefits of these technologies for the conduct of clinical investigations and for study subjects;
- Regulatory or other barriers to implementing the technologies;
- The implications for patient protection and privacy, as well as data integrity; and
- The challenges presented by the “Bring Your Own Device” (BYOD) model – where study subjects use their own smartphones or similar devices for study participation – including how such devices can be validated, and barriers to pooling the data collected from various devices.
This information collection comes at a time when many companies are already evaluating the use of wearable sensors and other mobile technologies in the context of clinical trials. FDA’s acknowledgement that such technologies may provide value and efficiency in the clinical study setting is an important step forward. At the same time, numerous issues exist with respect to, for example, use of consumer-grade products for collection of medical data. Nonetheless, the request for comments from the Agency represents a first step on the road to potentially enhancing clinical study efficiency.
Electronic or written comments to this notice are due by December 28, 2015. This notice provides an excellent opportunity for pharmaceutical, biotechnology, and medical device companies to provide feedback to FDA on new and innovative technologies that the industry is beginning to use in its clinical development programs.