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Biopharmaceutical companies are treading lightly in the use of websites, chat rooms, and interactive online communications to support clinical research programs.
Biopharmaceutical companies are treading lightly in the use of websites, chat rooms, and interactive online communications to support clinical research programs. While there’s more activity—and comparable concerns—about promoting medical products through company websites and third-party postings, social media use is in its infancy related to the design and conduct of clinical trials, according to a recent report from the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu).
The main use of social medical by research sponsors is patient recruitment, reports Ken Getz, director of Tufts CSDD sponsored research program. Through discussions with a group of 20 pharma companies and contract research organizations last year, Getz and colleagues found that more than half plan to increase use of social media for recruiting patients in the US, 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.
At the same time, sponsors are concerned about patients utilizing social media to communicate with others about their experiences in a clinical trial, which can have serious consequences for a research program. Studies’ participants are 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 dropouts.
Despite these problems, Getz says that the use of social media in the research arena is “a runaway train,” and advises sponsors to use it to engage more with patients and learn how to avoid these pitfalls. Such interaction can provide feedback useful in planning research programs and gaining insight into the feasibility of a protocol design, Getz points out. A CSDD survey of patients indicates that they would like sponsors to use social media to solicit their opinions when designing case report forms and protocol procedures for scheduling patient testing.
At the same time, patients should bear more responsibility for their communications about experimental studies, Getz notes. Informed consent, he added, can be used by sponsors to remind subjects of the damage that can result from careless disclosures, both to the integrity of the study and to the privacy of trial participants.
More guidance from the Food and Drug Administration would support such efforts. While FDA has issued an initial advisory on use of social media related to pharmaceutical marketing, nothing has appeared relevant to clinical research, and sponsors are concerned that providing information on experimental products to patient groups can be construed as illegal promotion.