As we discussed in our webinar, Trends in Clinical Trial Site Selection and Patient Recruitment, while enrolling patients is vital to the success of a clinical trial, it can be a major source of research expense and start-up delays. As a result, multiple methods are used today to recruit patients, combining traditional tactics with an escalating adoption of newer media forms.
To gain an understanding of just how many of our webinar attendees have begun deploying advanced tactics to recruit clinical trial patients, we asked them: What’s your experience recruiting subjects through the use of clinical trial registries and health-focused social media?
The results of our poll:
- 50% said they hadn’t deployed these tactics yet.
- 27% said they found the process difficult to manage.
- 12% said trial registries were one of their best sources.
- 11% said other, and included additional notes of finding success through using online recruitment applications and trial-specific websites.
With 85 percent of U.S. adults using the Internet and 72 percent of those users looking online for health information within the past year, according to a survey by the Pew Research Center, it’s no surprise that it’s time for sponsors and CROs to get on board with going online for patient recruitment.
However, what does come as a surprise is that half of our attendees are not yet using online resources such as clinical trial registries and health-focused social media sites to find and recruit patients. And of those that have ventured online in social media for patient recruitment, 27% have found the process difficult to manage. Perhaps part of the frustration in either scenario can be attributed to questions and uncertainty regarding the use of social media—especially from the IRB perspective and other regulatory angles.
While we’re starting to see guidelines for social media and other “interactive promotional media” get framed both at the federal level and local level, most IRB and ethics committees are still reluctant to include studies on social media networking sites. This is likely due to a combination of factors, including a prospective review limiting a researcher’s ability to engage in spontaneous dialogue, and the fear that communication through social media may violate basic principles and requirements regarding communications to/with study subjects.
However, as researchers and IRBs strive to work closely together, they are developing communications plans with prepared messages and responses to post to social media that are both appropriate and carefully reviewed.
As for regulations from a federal standpoint, the FDA recently released the long overdue guidance, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” describing how companies can submit their advertising and promotional materials to FDA for review. While it still leaves many questions unanswered, we believe these guidelines are helping subside some of the fear and unknowns surrounding the use of social media, and predict guidance directly targeted at the clinical trial industry will soon follow. In fact, the FDA is currently working towards a July 2014 deadline to publish guidance on its policy towards internet and social media promotion.
For more information on trends in site selection and patient recruitment, feel free to download the slides and related eBook. Also be on the lookout for an upcoming infographic. If you’d like to be alerted when it becomes available, please leave your contact information in the comments section.
Joanna is the associate director of global site management services at Clinipace.