By Deb Borfitz
July 20, 2009 | Clinical trial sponsors are largely unaware of the conflict that arises when dealing with the new, increasingly Internet savvy e-patient who is highly motivated, well educated, self-advocating, and self-informing. “Most sponsors want to control information because they’re looking for scientific validity and want to protect their commercial interests,” says Bonnie Brescia, founding principal of patient recruitment company BBK Worldwide. “But the Internet is undermining that whole model.”
At some level, we’re all e-patients. Most of us, “the well,” use the Internet sporadically to look for information on nutrition, prenatal care, or some other topic of personal interest. About 35% of e-patients, “the chronics,” casually but routinely visit (perhaps even develop) helpful websites and online communities for disease-specific camaraderie.
But it is “the acutes,” representing only about 5–6% of all e-patients, who are the most significant users of online health resources, says Brescia. These folks spend endless hours online trying to cope with an acute illness or a recurrence or flare-up of a long-term condition. If necessary, they enlist the help of family and friends to quickly find the answers they seek.
E-patients typically love to share information and often do so without any apparent privacy or confidentiality concerns, says Brescia. These include trial participants who “unblind” themselves online so they can compare notes with other study volunteers and perhaps figure out who is and isn’t getting the placebo. To them, the Internet is an appropriate forum for broadcasting everything reportable about a trial—including the frostiness of a particular study nurse or how onerous they find the repeated blood draws.
The reality, says Brescia, is that “information control” in the Information Age is an oxymoron.
So how are sponsors to engage e-patients? First, by acknowledging that where people “live” online is where they want to stay. “Live where they live and reinforce the use of that medium,” says Brescia. Recruitment ads in any medium should provide an online mechanism for e-patients to get more information about a study and do an online screening to pre-qualify. Ideally, online ads also include a zip code locator search so e-patients can immediately identify a nearby study site.
Brescia also says, don’t be fooled into thinking the U.S. is the only place where the Internet really matters. North America accounts for only 17% of worldwide Internet usage; Europe, 26%; Asia, 40%; and Latin America, 10%. “The sophistication of e-patients transcends their physical location,” she says.
E-patients are more likely to “take action” based on information they collect about a trial and to make an informed decision to participate, the same characteristics that make them more committed to completing trial requirements later, says Brescia. Outreach also has a multiplying effect because they share knowledge with one another.
The challenge for sponsors is dealing with this empowered but “demanding” audience and anything they might want to say on social networking sites or open, uncensored blogs. “Even if there’s a confidentiality clause in informed consent documents, at what point does that conflict with patients’ right to information about their own health care?” says Brescia.
Brescia’s advice is to view all the online chatter as a partnering opportunity. Sponsors can use Google Alerts to keep tabs on what’s getting posted online about their company, compound, and trials to find out “what people are worried about and the types of questions they ask each other, and address them.”
Another partnering opportunity is provided by Community Builder, an adjunctive tool to BBK’s patient recruitment management system TrialCentralNet (TCN) 5.0, which allows sponsors to warehouse data on patients screened but unable to qualify for a current study. On subsequent studies, they then have an owned, pre-populated database from which to pull subjects.
TCN 5.0 itself functions as a social networking tool, in that it facilitates information-sharing between trial-specific communities of sites and sponsors, says Brescia. It also tracks what proportion of referrals come from which kind of online media, knowledge that can be used to refine recruitment campaigns or banked for future studies in a similar patient population or therapeutic area.
The “transparency dilemma” for sponsors is “finding the right balance between sharing information and partnering with e-patients and protecting scientific validity and proprietary knowledge,” says Brescia. “This is a revolution. You can participate in it, but you cannot control it.”