The number one challenge in keeping a clinical trial on track is subject enrollment. Subject enrollment is a topic that should be addressed when the clinical trial is first initiated at the investigative site however, subject enrollment goals and objectives are often thought of when goals and objectives fall quiet short of expectation. Perhaps, at the site initiation visit subject recruitment strategies should be discussed.
The Social Media Venues to be discussed;
The regulatory implication regarding the use of social media should certainly be discussed especially since it is the elephant in the room that everyone is trying to ignore. Usually, Institutional Review Boards (IRBs)/Ethics Boards will need to approve advertisement and recruitment material prior to their use; the aforementioned is considered advertisement. I have found many clinical research centers are very conservative and many times will not embrace new processes.
The following guidance http://alturl.com/8r2 is very familiar to us involved in Drug Development but as you are aware, the guidance has not been updated, given the social media platform of today. A survey conducted by the Tufts University Center for the Study of Drug Development “found that the use of social media in clinical research is minimal – so much so that most companies have yet to develop policies and practices in this area. FDA has made it very clear that they are not going to make platform-specific guidelines, like how to use Facebook, how to use Twitter, etc. for subject recruitment especially because they feel social media is still evolving. The Tuft survey found that only one in five firms that employ social media have used it to engage with patients, leaving it to third parties like patient advocacy groups or limiting their forays to banner advertisements.” Even though the majority physicians (> 85%) under 55 years of age use some sort of social media. It has been stated that “if industry wants to use social media, they have to embrace ambiguity” and of course, in the Pharmaceutical industry ambiguity is not embraced, so what is the answer? The key elements involved when dealing in ambiguity is to use your judgment. Pharma should begin the discussion regarding the use of social media for subject recruitment in clinical trials early, take the lead in developing guidelines and policies regarding subject recruitment in clinical trials and partner with Investigative sites, as well as with CROs