Applied Clinical Trials
The opportunities and challenges social media provides in the realm of subject recruitment.
Recruiting participants for clinical trials can be difficult; therefore, sponsors and research teams should consider incorporating social media into their recruitment strategy. Recruitment plays a critical role throughout the product development cycle, starting with protocol development and continuing to the end of the process when the team reaches their final goal in enrolling their last subject. This process includes a feasibility study that helps the team understand who comprises their target population; the optimal geographic locations for recruiting these subjects; how to educate the subjects regarding the risks and benefits of participating in the trial; and how best to retain the enrolled subjects throughout the trial in order to reduce the dropout rate.
Recruiting subjects for a clinical trial usually combines a variety of approaches. A supplement to traditional methods, social media can enhance or complement a comprehensive strategy, by offering a stream of new, continuously evolving technological tools. These tools can help reduce recruitment times; minimize screen failure rates; and meet recruitment goals, thus allowing the research team to obtain valid, credible data results and outcomes that meet regulatory requirements.
Conventional recruitment methods. The difficulties encountered in recruiting subjects for a trial can result in unfulfilled recruitment targets, causing delays in starting the trial, increasing the budget, and ultimately producing an underpowered trial.1 When this occurs, the data collected for analysis are too weak for a proper evaluation, and the results are therefore, inconclusive.
Throughout the years, sponsors and research teams have used a variety of methods to attract and retain volunteers for their studies. Patient recruitment tools have traditionally consisted of print media, mass media, or grassroots efforts such as discussions between patients and doctors. Print media include such items as brochures, newsletters, posters hung in doctors' offices or clinics, and newspaper ads. Although this form of recruitment has enjoyed a degree of success, it has limitations that can affect how quickly a site meets its recruitment targets. The layout of the material must be designed and approved; the cost to print and distribute the material must be incorporated into the overall budget; the geographic reach is limited to a specifically targeted distribution area; and the quantity of material needed must be estimated reasonably accurately in order to avoid producing too little (failing to advertise sufficiently), or producing too much (wasting valuable resources).
Mass media elements of television or radio spots offer some advantages over print in that they can reach a wider geographical audience, as well as "speak" directly to the targeted patient via an actor explaining the situation and encouraging a subject to call or visit a website for further information. The drawbacks to TV or radio ads are that they are usually quite costly to produce and that they need to be aired during an optimal time slot in order to reach the intended demographic group. In addition, with the technology available today, many viewers opt to record a show (e.g., with TiVo® , a digital video recorder), and then fast-forward through any commercials, or watch programs from a DVD, and thus bypass the main stations altogether. With radio, listeners can now subscribe to satellite broadcasts offering stations with no commercial interruptions. And finally, people can also purchase iPods or MP3 players, download and record their favorite music, and thus circumvent mass media completely.2
Grassroots efforts such as doctor/patient discussions or word of mouth through family and friends offer the most intimate, and most likely, credible way of connecting to a potential subject. If a trusted doctor mentions a pertinent clinical trial to a patient, the latter is apt to be more receptive to joining that trial than by having merely read about it in a brochure. If a family member or friend hears about a trial, again, the interpersonal relationship can be a powerful element in motivating someone to consider volunteering.
Conventional methods of recruitment are mainly comprised of non-interactive tactics, a one-way communication from the sponsor to the potential volunteer. Likely subjects see a newspaper ad or hear a radio spot that instructs them how to contact someone for further information if they are interested in participating, by providing a telephone number or website address. While these techniques are useful and remain important components today, the evolution of the Internet and online tools has added a whole new dimension to recruitment.3
Defining social media. Social media or social networking sites (SNS), are web-based sites where a conversation can take place between two or more people where, in short, there is the opportunity to exchange information. People can belong to virtual communities that enable them to join various discussions and participate with others in the group. They often come together based on common interests such as a hobby, an educational interest, or a news event. The impact on society has been tremendous: People are connecting all over the world, holding conversations, sharing pictures, and exchanging information from anywhere they can connect to the Internet; SNS have been growing at an incredible rate.4 The impact is far-reaching and has radically changed how we conduct both personal and professional business.5 For instance, in the medical community, nurses can actually go to a meeting or a conference via Facebook, Twitter, or other SNS, and are able to get responses immediately from colleagues across the globe, not just those in a local conference room.5
Twitter is a website where users establish accounts and can then instantly broadcast information to fellow users who are also connected to Twitter.7 Users can share messages about what they happen to be doing at a point in time, opinions about news events, or just random thoughts.5 The messages they send are called "tweets," which are limited to 140 characters.7 They can also post pictures or links to websites that they would like their followers to check out.
Facebook, launched in 2004, is another website that people can sign up to belong to; boasting a membership of over 400 million users as of March 2010,8 it has rapidly become one of the most popular SNS worldwide. On this site, the person who establishes a Facebook page has the ability to accept or reject a friend. Each friend allowed into the user's Facebook page can see all the photo albums, videos, or posts that the page's "owner" has uploaded.9 This site offers several features that allow the user to convey a broad range of information. Facebook has gained a lot of ground over the years as corporations have joined in to take advantage of its popularity among Internet users. Companies have set up their own Facebook pages that allow them to advertise and sell their products to consumers who are able in turn to offer feedback on what appeals to them and what does not.5 For instance, even local news stations have gotten into the game by offering free items to any user who accesses their site and votes a thumbs up ("like") for the prize give-away of the day. This technique allows the station to collect marketing data on how many people view their site, watch their program, and other demographic information of interest. The Facebook page owner also has the ability to broadcast a news-feed message to all of the people who have been accepted as friends by that user.5
Another contemporary form of communicating is texting. When people send text messages, they are sending information from one cell phone to another, or perhaps to a portable hand-held device.10 This is a way for people to communicate rapidly to a mobile phone even if they lack access to the Internet.
The growth of interactive websites and web 2.0. As stated previously, original World Wide Web surfing was mainly a one-way form of communication with the site owner providing and controlling the content. A person or company puts information on a webpage, and other people then visit that site to learn more about that particular topic. This style of interaction is designated as web 1.0. However, with the evolution of interactive capabilities, the web has gone from a one-way street to a two-way interactive exchange of information. Now, not only can people visit a site to get information, but they can also post comments on it, provide opinions, upload pictures or videos, or ask questions about the content; this interactivity is referred to as web 2.0.11 Web 2.0 denotes the fact that users can now interface with a site and turn the one-way approach into a two-way conversation. Online communities have popped up that allow people to join a group defined by such things as an interest, a geographic location, or a religious preference. Some examples of web 2.0 tools include SNS such as Facebook; blogs; various forms of file-sharing sites; and Wikis.8 SNS have allowed organizations to achieve a unique form of customer intimacy like never before.12
Cost-effectiveness, speed, and efficiency. The advantages to using social media for recruitment are many. Social media offers a cost-effective approach that can give the biggest impact for the money.2 Once a website is created and the content entered, access to a potential audience is tremendous. With the push of a button, a sponsor can potentially be in numerous homes or doctor's offices across the globe. There is nothing to print out and physically mail. Sponsors can even reach subjects during a holiday period or late at night when brick-and-mortar businesses are closed. The speed at which word gets out is also a great advantage to sponsors. In the world of clinical trials, time is of the essence. Every hour saved translates into the potential to complete the trial on time or ahead of schedule, thereby getting a product to market faster, and thus realizing sales revenue sooner. This accelerated process can offer a tremendous boost to securing sales that will recoup the trial's costs.
When speed is a factor, Twitter can offer a great advantage to recruiting for a clinical trial. For those who have signed up to follow their Twitter account, a sponsor can reach potential volunteers in real time. Twitter can be used to share information quickly with people interested in their trials; gather real-time data and feedback; and begin to build relationships with subjects, truly engaging the target audience.6 It allows for the continuous exchange of information at rapid speeds not experienced through traditional recruitment methods.
Accessible, convenient form of communication. Today's technological advances render greater accessibility and convenience of communication and information than ever before. People can download medical information to their portable laptop, iPad, or iPhone with a few easy steps. By logging on to the Apple iTunes store, users can select the Medical category from a drop-down menu of options. Once there, they can select from any number of applications (called apps) that meet their needs, from infectious disease, to blood pressure, to human anatomy, just to name a few.13 Many apps are free, others charge a nominal fee. There are even apps designed specifically for clinical trials. By using the search feature and typing in "clinical trials," users can view a list of applications dedicated to this area that is useful to both volunteers and investigators alike. Apple has an app for searching cancer trials, one for searching Alzheimer's trials, and even one that provides an overall guide to clinical trials. The Guide to Clinical Trials app is designed specifically for people interested in becoming research volunteers. This app, a guide compiled by The Center for Information and Study on Clinical Research Participation (CISCRP), gives potential participants insight regarding what is involved.13 Within this app, there is a section dedicated to answering questions such as what to expect or how to decide if participating is right for you.14 The guide also provides a glossary of terms so that the potential volunteer can get a deeper understanding of the trial. The Mobile App category offers an application that allows a potential subject or an investigator to search for a specific clinical trial in a therapeutic area of interest. The search taps into the National Library of Medicine and can look for studies being conducted all over the world.14
For people who do not own an iPhone or portable laptop computer, social media sites containing relevant information on participation in clinical trials can still be obtained by visiting a local library. Public libraries offer free computer time in which a potential volunteer can surf the web for information or access an SNS to participate in a conversation on health issues or clinical trials.
Ability to target a specific patient population. Through social media sites such as Facebook, a sponsor can establish an account that specifically targets the patient population they seek. For instance, if a pharmaceutical company is developing a cancer drug, it can set up an account dedicated to this therapeutic area. It can offer links to a variety of cancer websites such as The American Cancer Society's page, www.cancer.org. The sponsor's Facebook page can be further tailored to describe the upcoming trial, what is involved, and how a potential volunteer can learn more.
Instant global reach. A tremendous advantage of incorporating social media into a recruitment strategy is the ability to instantly reach anyone around the globe who has access to the Internet.15 This is a change from the traditional methods of print media—such as a poster hanging in a clinic's hallway or a brochure available in a doctor's office—that were limited to particular physical locations. Recruitment via social media travels even beyond the boundaries of television, for a TV broadcast may only reach a limited geographic location.
Interactive capabilities. Social media's interactivity further increases its benefits. It is one thing simply to read information; it is another to be able to interact and ask questions. Potential volunteers may be intrigued, but may have questions that go beyond the information provided on the site. They may wonder about their eligibility; whether they would need to travel; the possibility of pain or side effects; whether they need to stop taking current medications; or if they could incur personal expenses. In this era of advanced communications technology, we have become accustomed to instant gratification: If people have questions, they do not want to wait long for an answer. Social media enables the research team to respond quickly so as not to lose a potential volunteer's interest. This lends crucial speed to the recruitment process. The sooner a sponsor can screen and enroll subjects, the greater the assurance that the site will meet their enrollment criteria so the trial can move forward. In addition, faster enrollment means more time and money will be saved in the long run, and the ability to get to market faster is greatly improved.
As noted above, historical methods were comprised mainly of non-interactive tactics, a one-way message from the sponsor to the potential volunteer. With the evolution of social media sites, the recruitment process has grown into an interactive platform that facilitates conversation with potential subjects; responses to inquiries; and gathering feedback on potential barriers to recruitment, thereby addressing such concerns early in the process with the aim of staying on target and meeting recruitment dates and milestones. Social media offers greater personalization than the traditional media of TV and radio because people can now "belong" to an online community.
Confidentiality concerns. Although the use of social media tools offers many options and opportunities to sponsors recruiting for a clinical trial, there are also challenges of which the team needs to be aware. As technology advances, more and more information is exchanged electronically, putting personal data at risk of hacking and confidentiality breaches—something we hear about all too often in the news. Advertising for volunteers with social media tools allows the potential subject to respond and provide information for screening purposes. This information will most likely contain data that is confidential in nature (e.g., disease state or date of birth—elements often outlined in the inclusion/exclusion criteria). The Health Insurance Portability and Accountability Act of 1996 was enacted to help protect private health information of patients.16 The risk of people hacking into a website is ever present; however, recruitment personnel can help reduce this risk by ensuring that they have the latest anti-virus software and watch over the site; a well-defined quality assurance process is an important part of maintaining integrity and confidentiality.16 Even if the site is not compromised, there still is the chance that some of the material may be vague or misleading, causing potential volunteers to get a false impression of what participating may be like or the benefits they feel they will gain. Consequently, promises of cures and monetary gain are strictly forbidden.17
The possibility also exists for corruption, deceit, and immoral practices as well. Because of this concern, guidelines must be developed within the medical community in order to maintain high professional standards, adhere to ethical practices, and maintain confidentiality.18
Lack of clear FDA guidance. In order to protect patients and volunteer subjects, regulations governing clinical trials have continued to expand throughout history. However, the government has been slow to respond to the explosion of the Internet and social media sites. Some hearings have reviewed this issue in the hope of providing specific guidance to sponsors and investigators, but concrete information has not emerged.3 This lack of guidance is a source of frustration for sponsors and regulators alike who want to ensure patient safety.
Information overload. With the plethora of websites at our fingertips, it is easy to become overwhelmed with the amount of material in cyberspace, and one can quickly become fatigued surfing the web. Enter a word or disease of interest into a search engine and a lengthy list of sites pop up. This swath of information can lead to frustration and confusion that might not have occurred in a traditional discussion between doctor and patient or with an easy-to-read brochure. When designing a social media patient recruitment strategy, the team must keep in mind and create a method that is clear and user-friendly. Subjects should not have to guess at how to obtain more information or take the next steps to enroll.
Reaching populations without computer access. Social media is cutting edge and becoming ubiquitous in society. However, it is not a useful tool if a volunteer does not have access to the technology that enables such tools. For instance, some elderly people may not have adapted to, or have a use for, a computer or cell phone. They may be more comfortable with the communication vehicles they grew up with, such as the landline phone, newspaper, or standard mail delivery. People who are impoverished and economically disadvantaged may not have the financial resources to invest in a computer or the ability to subscribe to a calling plan or purchase an iPhone. If these populations are required for the study, the recruitment team needs to include alternative methods in their approach.
The reality is that you may not get the necessary traffic to your particular website, Facebook page, or followers to your Twitter account. This growth takes time and may be achieved at a rate much slower than initially projected.
Recruiting subjects can be fraught with challenges, and close to 86% of the trials held in the United States do not actually meet their enrollment goals within the contractual period established prior to the trial start.19 Making the decision to incorporate social media into a recruitment plan needs to be done very early in the process. The research team or sponsor needs to identify the recruitment procedures and approach, and then incorporate them in the writing of the protocol.17
Ethical, legal, and regulatory considerations. Regardless of the strategy used to recruit patients, ethical and legal considerations must always be adhered to. Each study has its own unique criteria for inclusion and exclusion of study subjects or patients. Ethics dictate that the target population be evaluated to ensure that safety is of the highest priority, to determine if the population consists of adults or minors, and to figure out how to incorporate vulnerable populations or other groups requiring special consideration.
Institutional review boards (IRBs) help protect the well-being of every subject by providing an objective view of the research to be conducted.16 An investigator or sponsor may be very excited about a potential compound or device to be developed; therefore, it is critical to ensure that sound judgment is not eclipsed by passion and enthusiasm for the study. With the unlimited reach of social networking tools, the possibility of reaching vulnerable populations such as children, pregnant women, mentally challenged people, or folks who may be educationally or economically disadvantaged increases. It is critical to ensure that they do not fall victim to undue influence or any form of coercion.16 By reviewing the content to be used with the social media, an IRB can help maintain integrity and safety.
Protocol design. During the protocol design and writing stage of drug development, researchers must consider the inclusion and exclusion criteria of the subjects they will need for their product or device. They must also consider the logistics of how the patients will be recruited and the various methods to be enacted. Recruiting subjects for a trial goes hand-in-hand with the informed consent process.17 This is the first step in providing information to potential subjects, so this process must be accurate and not misleading. The protocol needs to include a section that outlines the strategy for recruiting patients, who will be targeted, the methods that will be used to reach those subjects (e.g., television, newspaper, etc.), and the rationale for those options.17 Along with the protocol, the tools to be used in recruiting subjects should be included when submitting information to the IRB, ethics committee, or appropriate regulatory board for approval.17
Standalone strategy or complement to other outreach tactics. Searching the Internet for health information has gained popularity over the years as more and more facilities and providers have come on board with such sites as WebMD or MedlinePlus. In an effort to educate people about the options available for their condition, pharmaceutical companies are providing information about their products along with material pertinent to the disease their product treats. People getting their information from these sites are known as eHealth or ePharma consumers.20
Phase III trials command the largest number of patients in order to meet specific data requirements of the various regulating authorities.21 With regard to securing a pre-determined statistically appropriate number of subjects, sponsors need to recruit above and beyond that level in order to accommodate dropouts, that is, subjects who do not complete the trial for various reasons (such as moving out of the area, death, diminished interest, etc.). A sponsor must consider how quickly they will need to recruit, the optimal geographic location that will enable the best potential recruitment, and the budget amount allocated for recruitment. These combined factors will help determine the tools used in recruitment. It is not unreasonable to consider using social media as a standalone tactic if there is a certain level of assurance that the targeted population can be reached with this method. Given the advantages and disadvantages of social media, the sponsor will need to decide whether that approach alone will reach their intended audience.
Many combinations of options can work for any given trial, and social media tactics can be blended with traditional recruitment methods.22 A TV ad may direct someone to a Facebook page containing details on the trial or doctors' offices may display posters that depict the various iTunes icons for applications that can be downloaded to smartphones. Although scientific in nature, clinical trial recruitment can benefit from applying a business model approach. The concepts of building a brand, product and market planning, sales strategy, and maintaining participation are at the core of the model.23 Social media is another tool that can aid with this model and approach.
Therapeutic areas and social media. When considering whether social media will work for a particular trial, understanding the patient population and therapeutic area are key elements. Not only does the sponsor need to know the specifics of the disease and indication, but they need to be aware of how the disease may impact potential subjects' lives. For example, if any patients have diabetes, will they be connected to sites that offer healthy alternative recipes? Will they be interested in exercises that can help them in their struggle? Where can they learn about other ways to manage their condition? Are there others out there fighting the same battle with whom they can share experiences? Once the sponsor identifies these elements, they can then tailor their social media accordingly so as to attract the proper audience for their trial.
Future options of social media within clinical trials. Social media has the potential not only to help recruitment tactics, but also to take a step further and support volunteers in the course of a trial, and even afterwards during follow-up. Once a sponsor has obtained the required number of subjects, it is critical not to lose participants during the study. Social media can help keep subjects motivated by posting reminders to their Facebook accounts, sending a text, or tweeting them at a particular point in time. Providing patient reminders will help keep subjects compliant with the treatment protocol. A simple text of "Hi Mr. Smith, don't forget to eat something before taking your medication this morning" can be very beneficial. In turn, patients can provide feedback on how things are going, how they are feeling, or ask questions about unclear items.
An advantage of using social media during a trial is that friends and family can join the patient's online community and offer words of encouragement or support. They can post pictures to the patient's Facebook page or upload a silly video offering comic relief. This capability is truly meaningful if a patient is confined to a hospital setting and not permitted outside visitors, a common scenario for first-in-man, Phase I trials. They can now "visit" with loved ones online, staying in touch with what is going on at home.
Throughout the trial, social media can enable patients to obtain additional information or ask questions. For instance, they may need further clarification of the instruction "do not eat prior to taking the medication." Does this mean immediately prior, an hour before, or several hours? Although they may have already received the specifics at the start of the study, once they return home they may realize that their understanding is not as complete as they had thought it was. A unique circumstance could arise that may prompt a question. For instance, a patient who had not planned to travel at all is suddenly required to take a trip for business.
Once treatment is complete, patients can post follow-up information on how they are feeling or any changes that may have occurred. They can even discuss the possibility of participating in future trials.
There are thousands of clinical trials taking place at any given time across the globe; in the United States alone, there are between 5,000 and 6,000 protocols responsible for conducting over 80,000 trials a year.19 According to the U.S. Food and Drug Administration, there are close to 4,000 active investigational new drug applications at any given time.19
Demographics. The Internet is a powerful tool that offers a large pool of candidates. According to the Internet World Stats website, as of March 31, 2011 there were two billion Internet users. The latest data estimate that there are 2,095,006,005, a number that is growing every day.24 There are 272,066,000 users in North America alone and another 476,213,935 in Europe.24
The Facebook user statistics show that there were 710,728,720 users as of June 30, 2011; 167,999,540 in North America and another 208,907,040 in Europe.24 The Facebook penetration rate is an astounding 48.4%, offering a tremendous universe of potential subjects; in Europe, the rate is 25.6%.24 English is the number one language used on the Internet with 565,004,126 users or 16.8% of the total languages. Chinese comes in second with 509,965,013 or 24.2% of the total.24
ePharma consumers are a rapidly growing segment of Internet users with over 100 million consumers as of 2009.2 Advertisers are now shifting their focus to these consumers. The reward is that research teams have found online options to be as much as eight times lower in cost compared to traditional recruitment tactics of print media, TV, or radio.2 For example, the average cost per referral for a CNS study using a radio ad is $595 and a newspaper ad is $664; by comparison, an online ad is only $175.2
As competition for clinical trial subjects continues to intensify, sponsors and investigators need to broaden their strategies for recruitment and retention. The advanced technology available today allows them to tap into a variety of social networking platforms. With increased use of these tools, sponsors will continue to get more creative and find ways to reach the necessary patients. Social media is an additional tool in the clinical research toolbox that allows for a cost-effective way of connecting to a large population. Sites can be tailored to each unique situation, and the research team can receive instant feedback. However, with any valid strategy, the advantages and disadvantages must be clearly outlined and weighed. Only then can the research team move forward with a level of confidence that will allow them to attain their desired recruitment goals.
Christine Andrews, MS-CRA, MBA is Senior Manager, Proposals at PAREXEL International, 195 West Street, Waltham, MA, e-mail: Christine_D_Andrews@Yahoo.com.
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