Social media can be an effective and easy way to connect with friends and professional contacts. However, it can also serve as a tool for institutions and principal investigators involved in enrolling subjects in clinical research to connect with prospective patients and subjects for clinical trial recruitment.
The research shows that, to-date, there has not been a significant amount of effective use of social media for the recruitment of patients and subjects for clinical trial research. Specifically, the Tufts Center for Drug Development at Tufts University reported on the use of social media in clinical trial research in June 2014 after conducting a nine-month study in 2013 (the “Study”). The Study results demonstrated that the majority of participating drug sponsors posted patient recruitment ads, but less than 1/3 interactively engaged in recruitment. While the Study only included pharma and biotech companies, it is reasonable to assume that device manufacturers and sponsors are also not effectively using social media to engage and recruit patients.
Given the enormous amount of time dedicated to patient recruitment for clinical trials, one would expect institutions to look beyond traditional recruitment methods, such as print, radio, and principal investigator relationships. The internet tends to be the first place that patients and caregivers go for medical information. Therefore, it should serve as a primary resource for information about clinical trials. Moreover, the benefits of recruiting online are numerous - lack of geographic constraints, the ability to access a larger patient population, obtain real-time adverse event reporting and improve feedback from patients, faster enrollment, minimize administrative burdens on sites, and cost savings.Institutions and principal investigators, however, have not jumped on the internet bandwagon for promoting trials for a number of reasons. One significant concern is the fear of navigating the legal regulatory landscape and not understanding the parameters of what is, and is not, appropriate. Fear of violating patient privacy and confidentiality is also of great concern.
The regulatory guidance on social media use in clinical trials is difficult to piece together, and it is not comprehensive or well organized. In fact, the regulatory guidance seemingly has been promulgated independently by several agencies, HHS/OIG, HHS’ Office for Human Research Protections and the FDA, and spans a period of about 12 years:
- HHS OIG, Clinical Trial Websites, A Promising Tool to Foster Informed Consent (May 2002)
- OHRP Guidance on IRB Review of Clinical Trial Websites (September 2005)
- FDA Guidance for Industry, Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human & Animal Drugs & Biologics, (Draft, January 2014)
- Recruiting Study Subjects – Info Sheet – Guidance for IRBs and Clinical Investigators (FDA website)
- FDA Guidance for Industry – Internet/Social Media Platforms with Character Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Draft, June 2014)
- FDA Guidance for Industry – Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about Drugs and Medical Devices (Draft, June 2014)
- FDA Guidance, Informed Consent Information Sheet – Guidance for IRBs, Clinical Investigators, and Sponsors (Draft, July 2014).
While some of the guidance is less informative than others, viewing all of it together provides a glimpse of the government’s perspective on the use of social media in clinical trials. The most significant take-away and recurring theme throughout the guidance is that the use of social media to recruit clinical trial participants may be part of the informed consent process. It should be noted that informed consent is mistakenly viewed as synonymous with a subject’s signature on the consent form. However, this is only part of consent process. Informed consent includes providing a potential subject with adequate information to allow for an informed decision about participation. Interestingly, while the government seems to suggest that social media can be an effective tool to recruit patients, it also warns about the use of Twitter and other platforms with character-space limitations. While social media presents opportunities for clinical trial recruitment, the lack of cohesive regulatory guidance presents challenges. Institutions, clinical research organizations or principal investigators interested in exploring the use of social media to improve recruitment into clinical trials, should consult legal counsel in order to ensure that the social media initiative complies with law.