While biopharmaceutical companies are using websites and third-party postings to provide information on medical products — despite a host of regulatory issues — social media use is in its infancy related to the design and conduct of clinical trials.
A recent report from the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) finds that sponsors are treading lightly in the use of websites, chat rooms and interactive online communications to support clinical research programs, focusing primarily on patient recruitment.
More guidance from the Food and Drug Administration would support such efforts, but so far the regulators have focused on online communications related to drug marketing and promotion. FDA recently issued a draft advisory on how pharma marketers should submit examples of online communications for review by the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER). The guidance addresses how and when pharma companies are responsible for information posted online about their products, based on the firm’s control of an internet site or relationship to third-party sponsors. FDA indicates that marketers may not be responsible for truly independent third-party communications about a product — an important clarification, but one that does not fully cover many situations where a marketer becomes entangled in online discussions.
CDER’s guidance agenda indicates that more advisories are in the works on Internet communications using site links, hampered by space limitations, and intended to address third-party misinformation about a product. But these documents are not expected anytime “soon,” as OPDP director Tom Abrams indicated at the recent Pharmaceutical Marketing conference sponsored by the Drug Information Association that FDA has met the Congressional deadline for social media guidance with this latest publication. And it’s not clear that this proposed approach for companies to track and disclose online communications will be workable and helpful — or a further impediment to practical industry use of the Internet.
Meanwhile, sponsors are seriously concerned about study participants utilizing social media to communicate with others about their experiences in a clinical trial, which can have serious consequences for a research program. Through discussions with a group of 20 pharma companies and contract research organizations last year, Ken Getz, director of Tufts CSDD sponsored research program, and colleagues heard reports of patients entering online chat rooms to discuss responses to treatment, adverse reactions, protocol details, and even offering to cut pills and share them so that other subjects are more likely to receive treatment instead of placebo. Such actions can introduce research bias into a study, distort adverse event rates, and encourage non-adherence and early drop-outs.
Despite these problems, Getz says that the use of social media in the research arena is “a runaway train,” and that sponsors need to find ways to engage with patients to gain feedback useful in planning research programs and designing protocols. A CSDD survey of patients indicates that they would like sponsors to solicit their opinions online when designing case report forms and testing procedures. More than half of the firms in the study said they plan to increase use of social media for recruiting patients in the U.S., and some firms will do so in Western Europe. Those companies taking this route are looking to track specific results, such as number of leads generated, patients screened, screen failure rates, and subject randomization rates.
Meanwhile, sponsors have to be careful that any interactions related to experimental products could be construed as off-label communications and get everyone into trouble.