Regulatory and Ethical Implications of DCTs

As DCTs gain traction, regulatory bodies worldwide are adapting their guidelines to encompass this new model. For instance, the U.S. FDA has been proactive in providing guidance for DCTs, focusing on data quality, patient safety, and the use of electronic solutions. Some other useful links regarding DCTs worldwide include:

• FDA Guidance On DCTs Webinar
• EU Recommendations for DCTs
• UK Guidance on DCTs
• Canada’s discussion of DCTs

In conjunction with regulatory changes, the increased prevalence of DCTs has prompted some ethical-related concerns. For example, consider the use of eConsent, which while helpful in a DCT, must still uphold the principles of traditional informed consent. Thus, an eConsent platform should not only ensure participant comprehension (e.g., via interactive modules, videos, and quizzes), it must provide an easy way for patients to contact study personnel for clarifications.

Another ethical consideration is that DCTs may unintentionally exclude those without access to technology or digital literacy. In those instances, efforts must be made to provide necessary resources (e.g., wi-fi) or alternative-participation methods.