Social Media's Impact On Clinical Trial Enrollment

By Cliff Mintz Ph.D., Life Science Leader magazine

Human clinical trials play a pivotal role in the development of all new prescription drugs and treatments. At present, there are more than 4,000 experimental new drugs in various stages of clinical development. And, at any given time, 70,000 clinical research studies are in progress. In 2008, total spending on clinical research grew to $94 billion with an annual growth rate of roughly 6.9%.

Historically, clinical trial recruitment by drug companies (sponsors) relied almost exclusively on print, radio, and in some instances, television advertising. However, in recent years, online clinical trial registries such as Clinicaltrials.gov and Centerwatch.com, company-sponsored clinical trials websites, and online patient recruitment companies have been added to the armamentarium to bolster clinical trial enrollment. Advances in electronic data capture, clinical data management solutions, e-diaries, and interactive voice response systems have also helped. Yet, recruiting patients into clinical trials continues to be a daunting challenge for most sponsors. Some of the reasons for the difficulties include: 1) increasing complexities of clinical trial protocols, including patient type or more rigorous inclusion and exclusion criteria, increased number of patient visits, and hospitalizations, etc.; 2) fierce competition for the “same patient type” because of an overlap in development of experimental drugs in certain therapeutic areas, including oncology, diabetes, cardiovascular, and neurodegenerative diseases; 3) negative publicity of experimental drugs because of recent highly publicized recalls and safety issues with approved products; and 4) a generalized lack of public awareness about the availability and access to human clinical trials. 

It is estimated that poor patient enrollment has delayed the start of almost 85% of all human clinical trials. And, these delays can be costly; reducing the length of a clinical trial by just one month can generate an additional $40 million in sales revenue for a newly approved prescription drug. Because of this, patient recruitment has become a big business. Last year alone, $2.3 billion was spent on patient recruitment, and the size of this market is growing 15% annually. The rising cost of patient enrollment has prompted many sponsors, CROs, and patient recruitment firms to evaluate new strategies to improve recruitment outcomes. Increasingly, many of these organizations have turned to social media to bolster patient enrollment.

Why Social Media?
The term social media means different things to different people. However, there is general agreement that it involves online interactions between individuals who share common interests and activities. These interactions are facilitated by online networking websites like Facebook and MySpace, microblogging platforms such as Twitter, video-sharing sites like YouTube, and a growing network of blogs, online bulletin boards, and e-forums. 

2010 study by the Pew Research Center found that 57% of Americans use the Internet to search for medical and health-related information, and 52% of adults aged 18 to 64 have a profile or belong to at least one social networking site. Recent estimates suggest that Facebook has more than 500 million subscribers, and Twitter recently surpassed 190 million users (who tweet 65 million times per day). “This represents a tremendous opportunity for clinical trial sponsors,” said Scott Connor, VP of marketing at Acurian, a patient recruitment company. He added that because social network users have actively opted-in to participate, “They are more likely to favorably receive and act upon messages received through the network than they would be through unsolicited communications and traditional advertising.” Bonnie Brescia, cofounder and president of BBK Worldwide, agrees with Connor. “Online outreach [including social media] offers tremendous relevance to patient enrollment and retention,” she said.

Despite the potential opportunities offered by social media, Lance Nickens, owner of The Patient Recruiting Agency (TPRA), cautions that it will not replace or supplant traditional methods used for patient recruitment and retention. “We have not necessarily seen a decline in the ROI for conventional or traditional recruitment methods,” he said. Nickens added, “We have found that when social media is integrated with traditional advertising methods, it can help to accelerate enrollment and reduce the overall cost per randomized patient for most trials. However, social media by itself may not be enough in most cases.” 

Acurian’s Connor is a bit more sanguine about the use of social media for patient recruitment. “It is not a panacea,” he said. However, like Nickens, he believes social media (if properly implemented) represents a highly targeted, low-cost, and flexible solution that can greatly enhance trial enrollment.

Social Media Recruitment Strategies
While there is no single social media solution that can guarantee a universal uptick in patient enrollment, a number of social media platforms, tools, and applications are being evaluated. These include: 1) online patient communities like PatientsLikeMe, Inspire, and WeAre.US; 2) social networking sites including Facebook, MySpace, and Twitter; and 3) software applications that enhance search capabilities and improve access to clinical trial information.

Patient Communities
Online patient communities are formed around websites that have been designed to allow patients with similar diseases to interact with one another and exchange information via chat, blogs, bulletin boards, and email. While the number of online patient communities has rapidly proliferated in recent years, one of the largest of these communities is PatientsLikeMe (www.patientslikeme.com). The site is composed of 19 disease-specific subcommunities ranging from diabetes to multiple sclerosis. The community is composed of more than 40,000 members who are able to discuss and share information about their diseases and learn about new treatments or clinical trials that may be available to them. Shortly after the launch of PatientsLikeMe in 2004, study sponsors recognized that the site represented a potential source of “motivated” clinical trial participants. Members of PatientsLikeMe understand that data about their symptoms, treatments, and medical outcomes will be shared (anonymously) with study sponsors who may be looking for clinical trial participants. 

Other online patient communities (or so-called social support networks) that help to bridge the gap between those offering and seeking participation in clinical trials include Inspire (multiple therapeutic areas; inspire.com), WeAre.US (multiple therapeutic areas; weare.us), NexCura (oncology; nexcura.com), and Sharing Strength (breast cancer; sharingstrength.ca). Finally, BBK Worldwide, the patient recruitment firm, has created online communities for diabetes, asthma, and multiple sclerosis to develop a pool of potential participants for sponsors that conduct trials in these areas.

Patient recruitment experts concede that one of the major limitations of many online patient communities is their small size. While this may present a problem for some sponsors, Natalie Douglas, CEO of Idis Pharma, believes these communities may be ideal for sponsors developing treatments for orphan diseases, mainly because the size of the trials required for approval of orphan treatments is much smaller than those for nonorphan indications. Further, Douglas believes the size of online patient communities will continue to grow and become more useful to trial sponsors.

Social Networking Sites
The sheer size and enormous potential reach of Facebook, MySpace, and Twitter suggested that these communities could be a rich source of prospective clinical trial participants. To date, advertising campaigns on Facebook and MySpace have proved to be the most effective in terms of cost and reach. This is because these sites offer the ability to target advertisements to individual users’ pages (based on the information that they provided about their age, gender, and other characteristics). For example, age can be an extremely important variable when recruiting younger subjects for vaccine trials or older persons for trials on Alzheimer’s disease. Further, trial ads or announcements have the potential to be rapidly and widely disseminated through users’ friend networks. Finally, Acurian’s Connor — based on several years of experimenting with online social networks — suggested that clinical trial advertising campaigns on Facebook generally outperform those on MySpace and are far superior to Google and Yahoo placement ads. 

However, he emphasized that one of the most powerful and cost-effective patient recruitment features of Facebook and MySpace is “geo-targeting.” This feature allows advertisers to precisely target and direct trial messaging within a specific radius of a city or to a zip code or even IP addresses. Connor points out that “this is huge” because distance to a clinical trial site is the main determinant as to whether or not most patients participate in a trial (a 30-mile radius is the upper limit for most indications except cancer). 

While placing targeted ads on Facebook, MySpace, and other social networking sites appears to work well to improve patient enrollment, the “jury is still out” said TPRA’s Nickens on whether or not a static Facebook page for a disease indication or a particular trial will be a cost-effective recruiting tool. “The investment of time, cost, and regulatory issues with this approach suggests that it may be difficult to match the effectiveness of simply advertising on these sites,” he said.

Twitter, one of the increasingly popular social networking sites, is also being vetted as a possible patient recruitment tool. Many patient recruitment companies have Twitter accounts and a few clinical trial listing sites, including ClinicalConnection (www.clinicalconnection.com) and Medpedia (medpedia.com), tweet about ongoing and active trials. Another company, TrialX (trialx.com), which attempts to match patients to specific clinical trials based on online patient-generated health records, also has an active Twitter presence. Patients can send a tweet to @TrialX describing the type of trial for which they are looking, and Trial X can then tweet back a link to a list of potential trials. 

Because of its newness, the ROI for Twitter as a patient recruitment tool has yet to be accurately determined. Nevertheless, Carmen Gonzalez at Healthcare Communication Group believes Twitter and other social media platforms will absolutely be required to bridge the gap between clinical trials and the next generation of patients, who rely almost exclusively on social technologies to communicate. To that end, she recently authored an article (http://bit.ly/bbziwl) that outlines a regulatory-compliant strategy to utilize Twitter as a patient recruitment tool. 

Software Applications
Clinical trial listing websites like ClinicalConnection and Medpedia offer services that help match prospective clinical trial participants to appropriate clinical trials. While these clinical trials matching sites are relatively new, they are growing in popularity as clinical trial recruitment tools.

Pfizer recently launched a video channel on YouTube called
PfizerClinicalTeamChannel to help raise patient awareness about its clinical research programs. While posting videos on the YouTube website is free, Acurian’s Conner and TPRA’s Nickens believe the high costs and time required to produce videos will preclude their use as cost-effective patient recruitment tools.

Last year, Acurian launched a social networking application for Facebook and MySpace called Click It Forward, which is intended to raise clinical trial awareness. The application can be installed on users’ Facebook and MySpace pages, and online friends can then be invited to “click it forward” by installing it on their profile pages (for each friend who accepts, Acurian makes a contribution to a cause that was preselected by the original user). The program automatically becomes a part of a user’s profile page, which subsequently allows Acurian to send the latest clinical research or trial opportunities to individual click-it-forward communities.

The growing popularity and increasing reliance on smartphones prompted at least one company to develop a mobile clinical trial recruitment app. MedTrust Online, in collaboration with GlaxoSmithKline, developed the Cancer Trials App for the iPhone. The app is intended to provide quick mobile access to registered clinical trial information for oncologists and cancer patients. Some of the information offered by the app includes trial locations (within a 500-mile radius) for 12 common cancers; description of the trial by phase, gender, age, and study type; and a complete review of the trial with contact information and a visual map that pinpoints a user’s location to the nearest trials. Genentech (Roche) recently announced plans to expand its BioOncology research app to include oncology clinical trials. 

Apple’s recent introduction of the iPad has prompted a variety of software developers to begin work on clinical trial recruitment apps for the device. This is because the device is rapidly gaining in popularity among healthcare professionals and patients alike. Many believe the iPad has the potential to revolutionize clinical research.

Challenges
One of the major challenges facing the adoption of social media as a patient enrollment strategy is the lack of clearly defined regulations to guide its use. Legal and regulatory concerns have caused many corporate sponsors to limit the use of social media for any purpose, including clinical research. However, BBK Worldwide’s Brescia believes the existing clinical guidelines for patient recruitment can easily be applied to social media. “The internal guidelines established for risk mitigation by sponsors are usually more restrictive and limiting than those established by external regulatory agencies,” she said. Further, she added that clinical trial personnel are very familiar with regulatory guidelines and understand the critical importance of maintaining and preserving regulatory compliance during the conduct of a trial.

Late last year, the FDA convened public hearings to collect information to begin crafting regulatory guidelines for the use of social media by life sciences companies. The last time the agency issued guidance about online interactions with consumers and stakeholders was in 1996. Consequently, it is anybody’s guess when the FDA will finally issue these highly anticipated guidelines. In the absence of these guidelines, it is likely that sponsors will continue to shun and limit the use of social media for patient recruitment activities.

Another concern of many sponsors is the perceived inability to manage trial messaging and conversations about a trial on social networking sites. Many believe this lack of control may seriously compromise the integrity of some clinical protocols and jeopardize accurate reporting of trial results. Still others fear that “rogue” trial participants or followers may falsely report adverse events or call attention to safety concerns that may impede or hinder approval of experimental medicines. Finally, some sponsors and advocacy groups contend the use of social media to enroll patients may compromise trial participants’ confidentiality and privacy rights.

Despite these challenges, many patient recruitment companies and online patient communities are forging ahead and continue to experiment with social media as a clinical trial recruitment tool. Idis Pharma’s Douglas contends that burgeoning patient demand for increased access to clinical trials will push many sponsors to recognize that social media is a legitimate communication channel for patient recruitment.

Recommendations
Although the patient recruitment world is abuzz with excitement about the use of social media, it is important to keep in mind that social media is just another tool that can be leveraged to improve clinical trial enrollments. “Social media may not figure into the mix for every single trial,” cautions Connor. When social media is appropriate, he generally recommends a mixture of direct mail (70%), social media (20%), and print and broadcast media (10%) for most patient recruitment campaigns. However, he added that because the patient requirements for individual trials can vary, the optimum communication mix should be determined empirically for each patient recruitment campaign.

There is a growing body of evidence suggesting that social media is helping incrementally improve patient enrollment in clinical trials. However, significant gains are unlikely until the general public’s understanding about the importance of clinical research is vastly improved. According to CenterWatch, a staggering 75% of the general public says they have little to no understanding about the clinical research enterprise and participation. Moreover, a Tufts University study found that less than 5% of Americans know where to find information about relevant clinical trials. Finally, a recent report by the Center for Information & Study on Clinical Research showed that only 2% of the U.S. population participates in clinical research studies.

Most industry experts acknowledge that online patient communities, clinical trial advocacy groups, and even ads on Facebook, MySpace, and Twitter are helping to raise awareness about the vital role clinical research plays in new drug development. However, until drug makers and clinical trial sponsors embrace social media and become part of the “conversation,” it is highly unlikely the real value of participation in human clinical trials will be fully realized.

Used with permission from Life Science Leader magazine.