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A Social Approach to Patient Recruitment

Better use of Web 2.0 sites like Twitter, Facebook and PatientsLikeMe could be a boon for enrollment.
By Deborah Borfitz

May 18, 2010 | Sponsors need to think about patients as partners that help them complete trials,” says David Williams, chief marketing officer of six-year-old patient advocacy site PatientsLikeMe. “It’s a sacrifice in a lot of ways, not part of their normal routine.” PatientsLikeMe fell into the recruitment business when study sponsors recognized it as a viable source of motivated trial participants. When joining one of the site’s 19 condition-specific online communities, members understand that anonymized data about their symptoms, treatment, and outcome will be shared with select pharma companies in search of real-world insights—and possible trial participants. The click-through rate to the online pre-screener is 42%, almost triple the industry average for email marketing campaigns.

Although average recruitment speed has improved over the past decade, from roughly 24 months to nine months currently, target recruitment timelines have tightened such that most clinical studies continue to take at least one month longer than planned to hit

enrollment goals, says Bonnie Brescia, co-founder and president of BBK Worldwide. And Jeanine Estrada, director of business development at CRO Clinilabs, points out that most if not all forms of traditional advertising are decreasing in effectiveness. Insufficient numbers of enrollees is the top reason trials get delayed or abandoned, but the problem may be largely correctable by tapping into the legions of health-conscious people in social online settings, says Leigh Fazzina, principal with Fazzina & Co. Communications Consulting. To be warmly received, sponsors need only engage patients in conversation and play by the rules of their gathering places.

Winning Approaches

Since recruitment accounts for only about 4% of its revenues, PatientsLikeMe has no incentive to “over-promise,” says Williams. The company also avoids hyperbole and even the term study “subject,” widely embraced in recruitment circles, believing it engenders distrust. “A patient is a person, not a mouse,” says Williams. PatientsLikeMe has a strict protocol-vetting process to ensure that trials promoted to community members are scientifically sound and clinically significant. Novartis says that PatientsLikeMe helped accelerate its trial of an oral medication for people with multiple sclerosis (MS). “We were more than happy to do that one because it was a breakthrough delivery system,” says Williams. “Treatments on the market today are only delivered by injection.” Less than 10% of initial trial promotion requests are honored, half the time due to the protocol. Other sponsors balk at the service fee, based on a combination of community size, disease prevalence, and ease of identifying qualifying patients.

Several social networking sites have the potential to bridge the gap between those offering and seeking a clinical trial, including social support network WeAre.Us, NexCura (oncology), and 23andMe (genetic testing)., a Canadian online resource and community for women with breast cancer, encourages researchers to post trial enrollment opportunities to patients. Clinical trial listing sites ClinicalConnection and Medpedia promote trials on Twitter, effectively driving people to their sites for screening. Among the most promising outreach tools are Inspire, which introduces trial opportunities to disease-specific communities, and Acurian, which distributes email solicitations to appropriate individuals in its opt-in database while raising trial awareness through an application on Facebook and MySpace.

Academic medical centers like UCSF, Vanderbilt, and the Mayo Clinic do a good job on a regional basis with a trial matching service. MD Anderson Cancer Center has cast a wider net by creating a web link from Facebook to whisk interested “friends” to information about its clinical trial offerings, says Carmen Gonzalez, communications manager at the Health Care Communications Group. Mayo also offers tutorials to help other health care providers “wet their feet in social media.”

Singapore- and Silicon Valley-based startup Bubble Motion is making a splash with Bubbly, a voice version of Twitter, in India and Brazil where telephony and mobile phone infrastructure outpaces web access. In the U.S., the non-profit Center for Information and Study on Clinical Research Participation (CISCRP) launched an iPhone application that stores trial-related educational and reference material, provides a link to an online newsletter, and connects users to CISCRP for customized trial search options.

Most CROs limit their technology adoption to online screeners and patient recruitment companies generally have a referral tracking tool. But BBK has an evolving, experience-based patient recruitment management system (TCN e-Systems) that also helps project managers pick the right sites and countries and sites approach patients about trial opportunities.

There are other players in the trial planning and design category, including DecisionView (Study Optimizer), Provisio (iTrials), Trialytics, and i3 (i3Cube), all of which have built databases aggregating information from clinical and non-clinical sources. Their relevance to a study may depend on the geographies and patient types represented in the underlying database.

The database solutions work largely by manipulating existing data to answer sponsor queries, but the information tends to be “relatively static” and therefore of limited value, says Estrada. “People are interested in participating in a clinical trial at one point in time” and by the time they’re identified in a database, their health status and life circumstances may have changed. Thus database products may require updating monthly to be truly effective.

That’s not a problem for Provisio’s iTrials database (DirectConnect), remotely accessible, in real time, to sponsors and CROs via cloud computing, says David Bender, head of sales and marketing at Provisio. It was built from scratch out of 80 million individual patient health histories and represents 500,000 health care providers and 100,000 treatment facilities in the U.S. For purposes of assessing protocol feasibility or predicting and recruiting more effective study sites, that gives study planners more than 15 billion relevant data points to run inclusion and exclusion criteria against. Physician data is organized to assess potential trial participation as an investigator or the likelihood of referring patients to trials. DirectConnect improves recruitment rates by at least 33% because patients are fully pre-qualified for a trial prior to being contacted about the opportunity.

DirectConnect is especially suited to more complicated studies, such as those involving a drug washout period or concomitant conditions, where intelligent decision making requires a high confidence level with speedy access to longitudinal health information, says Bender. Provisio recently helped a company conducting a juvenile growth hormone study identify patients who had just been diagnosed with a growth deficiency and not yet on a conventional therapeutic. Information in a re-purposed database would have been too dated to answer the query. BioMimetic Therapeutics reports that iTrials solutions saved it $1 million over 12 months by directing it to sites with pre-qualified patients.

All the major pharma companies have begun investigating the feasibility of using electronic health records (EHRs) to identify potential trial participants, says Williams. But outside of the data-sharing world of PatientsLikeMe, implementation could be tricky. People won’t necessarily respond favorably to a trial opportunity knowing they were identified by a scouring of their private medical records. Another complication is that EHRs were created to “improve care, reduce redundant procedures, and avoid medical interactions,” not to be queried in support of clinical research, adds Brescia.

A more immediate possibility is a smart phone that transmits personal health and activity data to digital health records via wearable sensors, an idea being researched at the West Wireless Health Institute in San Diego. The idea is to quickly catch and treat emerging medical problems, says Gonzalez, but it will also create electronic profiles of patients. In the aggregate, these patient profiles will allow clinicians to improve the treatment model for all patients. Gonzalez envisions the same information being used to identify patients who might qualify for a given trial.

Building Relationships

No one technology will cure all that ails trial recruitment and the best combinations of tools are disease- and audience-specific, says Brescia. “We’ve enrolled an entire study in less than one month using [strictly] an online strategy and in other cases to supplement the traditional [offline media] approach, bringing in no more than 10% of total patients.” Online outreach provides “tremendous relevance,” making it greatly more cost effective, but often can’t provide the reach of television.

Chris Trizna, president and owner of Clinical Site Services, hopes to address the potentially huge number of enrollees at stake and ease sites’ call burden with an automated phone screener system designed to weed out 30-40% of callers who don’t meet minimum study criteria or don’t want to travel to the trial site.

Investigative sites could be encouraged to build their own database and targeted email campaigns, says Estrada. They could potentially create online communities specific to their practice or trial participants, with linkages to the major social networking sites based on search terms like “clinical trial” and invitations to be a friend or follower of the group. Unfortunately, commercial institutional review boards (IRBs) have yet to develop specific guidance for investigators inclined to blaze the social media trail.

The strategy can nonetheless be effective over the long term, and not simply to rescue a single, recruitment-challenged study, says Estrada. “A community doesn’t get built overnight. It can take time for social networks to establish themselves, and someone needs to encourage them to grow.” The advantage of growing a social network at the site level is that it comes with a level of familiarity that breeds trust and spreads it virally. In the first months after Clinilabs established a Twitter account, 76 people became followers of a website developed for its clinical research unit, which provides regular updates about the two dozen or so trials it conducts each year.

Health Care Communications Group tutors sites about how to harness social media before promoting trials. Using third-party geo-location tools like Nearby Tweets, they can immediately respond with an IRB-approved recruitment messages when a Twitter user within a prescribed perimeter uses disease-related keywords like “back pain” or “Alzheimer’s disease.” Once sites start to see a “return on connections,” Gonzalez expects their efforts will be further supported by trial sponsors. Sponsors seeking to align their recruitment aims with patient needs are advised to support the online initiatives of patient advocacy groups, at “arms length” for transparency.

One sponsor client had surprisingly good results using social media, even though it insisted on shielding its identify and that of the study drug. “For every 80 messages, we received 20 visitors to the study web site,” she says. “People were very warm … [and] thanked us. Imagine what we could have accomplished if we had a rapport [with our followers] and were perceived as actively engaged.”

Recruiting for trials on Facebook has proven successful in certain diseases. Clinical Site Services found the site outperformed Google and Yahoo placement ads “five to one” for a sexual desire study targeting young females, says Trizna. For an HIV study, Facebook also produced at least twice as many clicks.

Pop-up advertisements can be triggered on Facebook based on keywords in an online profile, such as diabetes, or being a fan of groups like the National Multiple Sclerosis Society, says Williams. His advice to sponsors is to stop lauding the benefits of participating in research, because the advantages are neither immediate nor guaranteed, and stop assuming patients with a chronic illness feel lucky to be in a clinical trial. “They might be more willing to participate based on the severity of their condition, or because they have a rare disease, but those are few and far between. Perhaps most importantly, sponsors need to start engaging in online conversations to de-mystify the clinical trial process, aid informed decision making, and give hope. That’s what motivates patients to participate.”

Guiding Lights

The adoption of social networking sites as communication channels now outranks natural search engine optimization, but life science companies have been understandably cautious given their legal and regulatory constraints, says Fazzina. The last time the U.S. Food and Drug Administration (FDA) issued guidance about online interactions with consumers was in 1996—a year before the launch of Amazon. The FDA began a one-year, fact-finding mission last November intended to conclude with industry guidance related to the online marketing and social media communications of pharma and medical procedures and, it is hoped, information exchange about clinical trials and patient recruitment.

A letter submitted to the FDA by Fazzina, Gonzalez, and others entreaties the agency to craft “adaptive” social media communications guidelines following existing models governing live media interviews and media tours via television and radio. The advocated policy would maintain IRB sovereignty over content while providing latitude to answer unanticipated questions, use acronyms and abbreviated messages, and do non-study-related messaging in keeping with social networking etiquette. “Simply sending IRB-approved promotional messages about a clinical trial without using the medium in ways typical of a common user raises suspicions of spamming,” they point out. Separately, a few companies suggested FDA give its “stamp of approval” to all legitimate online postings.

Sponsors have to date used social networking venues cautiously and almost exclusively as a one-way communication vehicle, either to eavesdrop on patient conversations or to deliver information about health conditions. However, two-way communication is an even more potent means to raise trial awareness, particularly if sponsors understand that they can wield control by creating their own sites and limiting membership to people with a certain medical condition. The longer term task would be to build relationships with a growing base of followers, creating a pool of potential subjects for studies in a particular therapeutic area. BBK has online communities for diabetes, asthma, and MS for about 20% of the sponsors enlisting its recruitment expertise.

A simple hashtag in front of keywords like “clinical research” or “clinical trial” can effectively serve as a study search engine on Twitter, adds Fazzina. Social networking venues don’t come with an instruction booklet but nonetheless have their own language and rules. Any message sent out by a corporation needs to be consistently “spot on” and thus formulated by a single governing group—an apparent shortcoming of several CROs with multiple Twitter and Facebook accounts.

Dialogue about clinical research within social networking sites and blogs can be easily monitored and measured by social media monitoring services, much like a traditional news clipping service, to understand public sentiments and respond accordingly. “There is currently a lot of online discussion in social spaces about back pain and migraine headaches,” says Fazzina. Patients are looking for information and want options, she says, but she doesn’t see pharma getting involved and taking advantage.

While trial sponsors are under-utilizing the tool, some recruitment vendors are blatantly disregarding rules set forth by the Health Insurance Portability and Accountability Act by soliciting private health care information on social networking sites, says Gonzalez. These are “red flags” of overdue FDA guidance.

It may be years before FDA clarifies its position about trial recruitment via popular social networking sites. Existing subject protection principles and marketing guidelines for FDA-approved drugs are usually sufficient for the online environment. “The internal requirements and guidelines of sponsors, set up for risk mitigation reasons, are generally more restrictive than those of external regulatory groups,” says Brescia. Ironically, the companies moving most aggressively into the social networking arena have no corporate-wide rules for engaging people online. In their view, the potential gains in terms of product marketing and trial recruitment outweigh the peril of mixed messaging.

This article also appeared in the May-June 2010 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.

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