ABSTRACT

All survey respondents were also asked about the impact of European Union Directive 2001/20/EC on direct-to-patient outreach. “It is particularly important to note that Directive 2001/20/EC mentions advertising. By simply including this word, the directive acknowledges the role of direct-to-patient outreach and education in furthering clinical research and development and opens the doors to expand efforts in this regard. As such, ‘advertising’ should best be interpreted as the use of communications to inform, educate and build trust among patients, investigators and sponsors of clinical research,” says Kibby. Regardless of the implications of the directive on global clinical trial patient recruitment, Ethics Committee respondents appeared to be noncommittal about the directive, most citing that they had “not considered” its implications for these issues.