FDA's "evaluation agreement" between its device center and an online forum for health care practitioners is a sign of the agency's growing efforts to reach out to the physician community and improve adverse event reporting.

Though no drug-related collaborations are currently under way, the value of online interactivity to the users of agency-regulated products will be tested by Center for Devices and Radiological Health through the agreement, which allows the center to temporarily access Sermo's content.

Sermo, which calls itself the largest physician community, provides a communication network for the medical field, enabling practitioners and industry to collect timely responses to questions from a vast sample of professional opinions. It has about 30,000 participating physicians and said it gains 2,000 new members each week.

The agreement allows CDRH to "take time and kind of kick the tires, try out different things and see what kind of value can be derived," Alex Frost, Sermo VP-research initiatives, said in an interview.

The company will work with FDA "to explore opportunities and introduce new ways in which physicians can become efficiently involved in the surveillance of medical product safety," he said.

Though CDER's Office of Surveillance and Epidemiology has not entered into such an agreement, the department said it will be "interested" to hear about CDRH's experience.

OSE also said it has been "actively exploring possibilities with numerous outside organizations for potential collaboration in post-marketing safety."

A collaboration with Sermo could help the agency address two long-standing postmarketing concerns. The site would enable FDA to provide a more accurate picture of adverse events, drawing from the sample of first-hand physician reports that document medical problems as they are encountered, and the site would help the agency to communicate with physicians as potential safety signals emerge.

FDA is reaching out to physicians in more traditional ways as well, and is designing a phone survey to ask doctors about improving adverse event reporting and early risk communication. As part of the questions, the agency will attempt to gauge its "trustworthiness" among doctors (¹ Also see "FDA’s Risk Communication Efforts Include Surveying Docs On Adverse Events" - Pink Sheet, 23 July, 2007., p. 19).

FDA may see potential value in Sermo's ability to improve communication with physicians, introduce new surveillance options and gather a broad sample of data to address specific topics quickly, Frost offered.

Sermo, based in Cambridge, Mass., launched about a year ago and offers free membership to physicians, some of whom are compensated for their efforts as a way to "give back" in return for their expertise, though Frost said about 95 percent of Sermo conversations do not have financial value.

On the Sermo site, doctors make "observations from their daily practice and then - rapidly and in large numbers - challenge or corroborate each others' opinions, accelerating the emergence of trends and new insights on medications, devices and treatments," according to ² Sermo's Web site.

The site allows doctors to interact in linear discussion threads broken down by topics (initiated by members) and also lets them formulate quantitative survey questions to "provide insights into the bottom-line opinion ... of the practicing community," Frost said.

So, for instance, during a discussion about a certain type of adverse event, a participant could send out a survey question like "have you seen a similar issue" and the system will tabulate the results, he explained.

"The end result is not only a lot of discussion around the detail of these issues, but ... could be a simple poll that has 300 physicians responding and 72% saying they have actually seen similar cases in the last six months."

Sermo anticipates improvements and forthcoming changes to the site after a new round of financing, led by Legg Mason Capital Management, raised $26.7 million, the company announced Sept. 12. The funds will be used to foster growth plans for the forum, accommodate the increasing number of participating physicians and better handle new content.

- Carlene Olsen (c.olsen@elsevier.com) and David Filmore (d.filmore@elsevier.com)

FDA Closes Gap In Postmarketing Dialog With Physicians Through Online Site

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