Patient Recruitment: Sites key to patient search - ICON plc

Patient Recruitment: Sites key to patient search
Even as new tools emerge for patient outreach, better engagement with trial sites is a must if
rising enrollment demands are to be met
by Michael D. Christel
Several converging forces in the world of clinical development are causing drug sponsors to
aggressively retool strategies in patient recruitment, as traditional outreach approaches can no longer
guarantee desired results and meet rising enrollment demands. With the evolution of personalized
medicine, pharmaceutical and biotechnology companies are increasingly emphasizing biomarkers in
their clinical trials, thus segmenting patient populations and adding complexity to already complicated
protocol designs. In addition, even as more clinical trials shift to emerging markets to improve patient
access and reduce study cost, the increasing competition in these regions for the same untapped
treatment markets has posed yet another challenge to recruitment strategies.
Meanwhile, sponsors and contract research organizations are dealing with growing pressure from
safety-sensitive regulatory authorities to produce more complete data packages. This means higher
patient enrollment is needed in many late-stage trials. Also, FDA and others are asking drugmakers to
deliver greater outcomes data on new drugs in real-world patient settings.
These mounting challenges have compelled sponsors, CROs, and patient recruitment agencies to
explore more creative methods in patient outreach and retention, as well as better approaches in
training and engaging science-focused sites and investigators on a recruitment campaign from the
onset. Experts also point to the growing role of digital-based recruitment, where the use of social media
is drawing particular attention, in reaching harder-to-find patients and investigators.
With these pressures, the pharma industry has been pushed from simply acknowledging the longdocumented
woes in patient recruitment and compliance to addressing the problems with new
solutions. Even with these efforts, slow recruitment or inadequate retention of trial subjects continues to
be a leading cause of study delays, with 85 percent of clinical trials failing to retain enough patients and
the average patient dropout rate across all clinical trials being around 30 percent.
Overall, two-thirds of sites fail to meet original patient enrollment requirements for a given trial,
according to the Tufts Center for the Study of Drug Development (csdd.tufts.edu).
Some acknowledge that broadly blaming low enrollment numbers on the perception that the general
public is disenchanted with clinical research can be misguided, and that there may be more practical
factors at fault.
“For individuals that participate in a clinical trial, to a large extent most of them have a passion to do
that, because they want to help fellow sufferers of their particular disease state try to find potential
cures or treatments that will alleviate a number of the symptoms,” says Terri Cooper, Ph.D., principal
and national leader, Life Sciences R&D Practice, Deloitte Consulting LLC (deloitte.com). “They’re
pretty keen to be involved. But I see some of the life sciences companies or study teams don’t give
enough thought to what is the additional amount of pressure that you’re putting on somebody to
participate in a clinical trial.”
Those pressures can include burdensome patient visit schedules, multiple blood tests, and in some

cases requirement for biopsy samples to evaluate biomarkers – demands that usually fall outside of
standard treatment care for a typical patient.
Although a balance needs to be sought between easing demands on patients and generating complete
enough data on the efficacy and safety of a proposed drug, the root problems for patient recruitment
usually arise much earlier. With an increasing number of drugmakers focusing on more complex
disease areas like oncology, the pool of available subjects for clinical trials has dwindled, and, thus, the
job of finding treatment-naive patients has become more daunting.
Patient-site alignment
As a result of smaller patient pools, it is imperative, experts stress, for sponsors to clearly define the
given patient population for a study and therapeutically and logistically, match the right physician
investigator and hospital setting with the right subjects. This is a feat that is not as easy as it sounds.
“That’s where a lot of times there are gaps,” says Kim Boericke, global VP, site services and strategic
outsourcing, i3 Research, the CRO division of i3 (i3global.com). “You either have access to the right
patient population, but you have the wrong physician, or you have the right physician but you don’t
have access to the right patient population. If you can connect those two, then the whole concern about
patient recruitment starts to go away, because you’ve got the right foundation and the right building
blocks to create that successful environment.”
The basic job of identifying qualified investigators and sites, however, can be difficult. The number of
physicians willing to conduct clinical research has dipped steadily in recent years, with recent data
estimating that as many as 70 percent of investigators only conduct one trial. The declining involvement
can be attributed to negative experiences running a clinical trial, unwieldy schedule demands for
already time-strapped doctors, as well as a lack of understanding from sponsors and CROs on the
reasons driving an investigator to participate.
“At times, there’s still too much of an emphasis from a life sciences company to think, ‘Well, [the
physician] needs to do this study; we expect you to drop everything,’” Dr. Cooper says. “You really
have to think about how are you driving the motivation of the investigator, and how are you going to
primarily keep them engaged and interested that they want to start another study.”
Achieving those results requires the close involvement of sites when forming outreach campaigns and
tailoring clinical trial advertising to local communities. Carmen Gonzales, manager of strategy and
communications at patient recruitment provider Healthcare Communications Group (hcg.com), says
there needs to be a uniform application of strategy among sponsors, study coordinators, investigators,
and clinical research associates around a patient recruitment program, even before the actual outreach
begins.
This includes training sites properly in introducing a study opportunity to a prospective patient and how
to support that patient during the screening process.
“If they don’t evaluate a patient properly at the beginning, down the road they’re going to have a
retention problem,” Ms. Gonzales says.
Therefore, she contends that patient selection should not end when a subject meets a study’s
inclusionary requirements, but regular follow-up is necessary to identify any potential conflicts that
might arise, such as family objections to study involvement or logistical or transportation issues that
could interrupt scheduled clinic visits.

“Without being trained and going through that proper evaluation process, you can really upend an
entire recruitment effort,” Ms. Gonzales says.
Due to those possibilities, sites also need to be willing to take on added assistance that they might not
have received in past studies, particularly in helping to identify the unique drivers for patient or
caregiver motivation in the target population. When a specialist recruitment provider or CRO are
brought into the process, sites often think it is due to inadequate performance, but experts stress that is
usually not the case.
“Lots of times, the clinical team looks at it from the perspective of, ‘Here’s probably a superior new
treatment and we just expect that everyone would know about it and be enthusiastic to enroll,’” says
Frank Kilpatrick, president, Healthcare Communications Group. “In our world, it’s a lot more of a
nuanced process, where we really need to identify the very specific patient motivations. Because it’s
less than immediately obvious what’s going to compel people to even consider participating.”
To aid sites in these determinations, several CROs and recruitment agencies are now routinely
conducting Web-based training for patient enrollment for all of their trials involving a recruitment
campaign. In addition, many companies have ongoing relationships with sites and employ their own
patient recruitment project managers that are in charge of helping and supporting sites in addressing
issues around enrollment. They also provide site management technology, allowing clinical research
teams to communicate directly with the CRO, who, in turn, can keep track of enrollment progress.
“There are lots of reasons why sites might not be able to recruit patients,” says Martin Lee, M.D., VP of
site and patient recruitment, PPD Inc. (ppdi.com). “It might be lack of sufficient patient populations, lack
of ability to identify the patients, or lack of ability to reach out or knowledge on how to reach out. So, we
really try to troubleshoot what are the issues of individual sites, and what can we do to support those
sites to improve their recruitment.”
Tammy Ice, director, patient recruitment and investigator services, INC Research (incresearch.com),
manages a team at the CRO that tracks and analyzes recruitment initiatives and patient enrollment
performance for clinical studies and identifies areas or sites requiring attention and improvement. Her
team monitors the recruitment effectiveness of all techniques recommended for a study, and interacts
with principal investigators and field study monitors as needed for site-specific planning.
In evaluating site recruitment performance, INC Research uses four basic criteria, according to Ms. Ice.
One, did the site generate sufficient interest in the trial program, including evidence of hits to studyadvertised
Websites, messages to the call center, or in-person visits to the site location? Then, if there
was significant interest, did the interest result in patients being screened for the study and ultimately
enrolling in the program? Lastly, did the subject complete the entire study or did they have to drop out?
Marketing agencies such as Blue Chip Marketing Worldwide (bluechipmarketingworldwide.com)
have also stepped up support services around subject enrollment. Tracy Slutzky, the agency’s director
of marketing, says the study coordinator plays a particularly vital role in the recruitment effort, because
they are usually the first human contact prospective patients have with the site.
“They are not usually trained in sales or customer service, but that’s a big part of their job, in being
successful and enrolling patients into the study,” Ms. Slutzky says.
Neil Weisman, executive VP and general manager, Blue Chip Marketing, describes the relationship a
step further, calling coordinators “gatekeepers” for study enrollment. He contends that the trial
coordinator is usually the one who will ultimately make or break a patient’s decision to participate in

clinical research. Influencing factors include how sensitive are coordinators to patient concerns, are
coordinators well informed about the study, and are they willing to problem solve if a patient has any
challenges and fears about the trial?
“They have to be equipped to answer all of those things,” Mr. Weisman says. “They have to be
equipped to manage those conversations and get them motivated or else the study will fall apart. If you
don’t have a good coordinator who knows how to connect with patients, I don’t care how many [referral]
leads you send them and how efficient they are, they’re not going to get anyone into the clinic.”
It is crucial, therefore, to focus significant time on upfront training at sites to raise enthusiasm about the
trial among the clinical team and set expectations around what kind of outreach will be required,
according to Ms. Slutzky.
One technique Blue Chip uses in this area is creating a study-specific brand, not only to appeal to
potential patients but also help study coordinators and physicians feel good about the trial and their
pursuits in developing potential therapies that could help patients.
Feasibility factor
Despite efforts to more effectively engage sites in patient outreach, investigators are, often handcuffed
by unrealistic feasibility assessments. Many consider this type of assessment to be the first step in the
patient recruitment life cycle. This process begins with an analysis of previous study metrics and
applying those to the planning and design of a new feasibility analysis. The lessons learned are then
incorporated into the planning of the next study.
Feasibility needs to be a dynamic process that recognizes changed parameters and allows the
recruitment plan to be adapted to reflect the changes, according to Janet Jones, Ph.D., senior director,
project information & feasibility, Icon Clinical Research (iconclinical.com), another CRO that provides
patient recruitment and site services. She says one of the big hurdles in delivering effective feasibility
studies for enrollment is that the analysis is often conducted on an early and incomplete protocol
synopsis.
“This is a frequent comment from sites – that they are asked to give recruitment estimates without
seeing the final protocol,” Dr. Jones says. “It is therefore important to ensure that the analysis is
considered as a dynamic process and any changes during the development of the protocol and
associated feasibility studies are fully evaluated and the impact of changes assessed in order to define
the final recruitment plan.”
Dr. Jones says it is also crucial that the sites know when the data that they provide will be used as a
benchmark of their planned recruitment performance.
Producing quality feasibility metrics in the first place, however, has long been a difficult task due to a
lack of accurate patient population data, Dr. Lee says. Historically, feasibility for patient recruitment has
been mostly done through surveys. Investigators will typically commit to enrolling a certain amount of
patients, yet there often is little data available to support that they even have access to the target
patient population, unless a CRO or a sponsor has worked with that site in the past on a trial for the
same disease indication.
“What we’re really trying to do is get away from [investigator] surveys as much we can when we do
enrollment projections, and we’re using a lot of different techniques,” Dr. Lee says. “The most useful
technique is certainly prior performance of clinical trials. So when possible, we’re choosing to go to
investigators that previously performed well on clinical trials in the same indication and possibly in the

same setting.”
PPD and others are also increasingly conducting direct investigator interviews, where they can discuss
the protocol in greater detail, challenge recruitment estimates, and settle on a more reasonable
enrollment projection for the trial.
Dr. Lee points to the steadily rising adoption of electronic medical records as another avenue to help
aid feasibility measurements for recruitment. Though issues of patient privacy and confidentiality could
slow their accession, access to electronic medical records will help clinical trial sites search for patients
faster and more methodically and enable sites to rely less on nurses and doctors to supply patients
who fit the parameters of a particular study.
In addition, the use of aggregated medical records can be a major advantage in realistically assessing
the impact of eligibility criteria when quantitating the patient population at a specific site.
“If you look down the road at how we’re going to be doing feasibility in 10 or 20 years, I think it will be
almost exclusively through electronic medical record data,” Dr. Lee says. “But right now, the amount of
data that’s available just isn’t sufficient to support that.”
Nevertheless, the incorporation of other metric tools, whether proprietary databases or various data
mining technologies, is increasingly becoming a standard norm for feasibility and site identification,
according to Ms. Boericke. Many companies have built home-grown clinical trial management systems
that allow them to track and manage performance on a trial.
Using these tools, data can be extracted on past site performance to identify which ones have had low
query rates or strong data generation, among several other metrics. Ms. Boericke says the increasing
availability of these data assets for CROs have helped uncover more accurate real-world estimates for
a potential recruitment program.
“What we’re starting to see as an industry is that data is leveraged and combined with publicly available
information – literature searches that have shown recruitment rates all over the world in certain
indications – and we’re able to leverage those pieces of information together to create a data asset that
gives us high potential sites,” Ms. Boericke says. “Then we go out and actually hone those high
potentials to get it down to sites we know are going to be able to perform successfully on trials.”
Access to this data can also arm companies with more sound information when developing clinical trial
protocols, which have long been criticized for often being overly complicated.
Ms. Boericke contends that protocols typically include too detailed or restrictive inclusion/exclusion
criteria. She says fewer patients who have pre-existing comorbidities are being sought for a trial
indication. As an example, Mr. Boericke points to oncology, where sponsors conducting advanced
cancer trials often seek subjects that have normal or close-to-normal liver function. In reality, however,
in many late-stage cancer cases, the disease metastasizes to the liver.
Such limitations could hamper sponsors in defining their “normal” patient population and ultimately
result in numerous dropouts when prospective subjects fail to meet the inclusion/exclusion criteria.
FDA, the European Medicines Agency, and other regulatory agencies only allow drug developers to
analyze patients that meet their protocol requirements.
“If you are so narrow in how you’re defining your patient, you’ll never be able to meet the overall
recruitment,” Ms. Boericke says. “That’s in a lot of ways what delays our recruitment timelines well past
what the pharma or anybody else said is the enrollment [deadline] for the trial.”

This means CROs contracted for a study must get involved from the beginning stages of protocol
design, according to Shaheen Limbada, senior director of clinical operations at CRO Cetero Research
(cetero.com). Mr. Limbada oversees clinical trials conducted at Cetero’s 76-bed facility in Toronto,
which focuses on testing allergy and asthma therapies.
He says in many cases, Cetero actually writes the protocol.
“Sometimes, the folks that are coming up with the theory behind [a protocol] have some great science
behind it and some great questions, but if a site or a CRO does not get involved in the process to kind
of balance that, it can lead to recruitment struggles,” Mr. Limbada says. “We end up finding a good
balance where we can get the answers they want, but also make it something feasible that we can
achieve here.”
Mr. Limbada acknowledges that in Cetero’s focus indications, the number of patients who do not qualify
for a study has risen sharply in recent years due partly to stringent protocols.
“With the race to first-to-market being so important for pharma companies, many sponsors are looking
for early signals in their clinical studies, which help them make decisions about their drug candidates,”
Mr. Limbada says. “As a result, we’re seeing more complex designs with stricter criteria for which
patients to include.”
Digital driver
Amid such challenges as protocol complexity, patient recruiters have had to become more inventive in
reaching intended subjects, including increased efforts around digital recruitment. A growing number of
patient referrals have been generated by online sources compared to traditional print or TV/radio
outreach. Varied e-recruitment tactics continue to emerge on the scene, including most notably social
media, but also online screeners, as well as more nascent Internet tactics such as Web listening.
In addition, with the growing popularity of mobile devices, use of text messaging and smart phone
applications has become more widespread. Many organizations are using expert providers of short
message service, such as the solutions company Exco InTouch, to affordably and more efficiently
target patients for study enrollment. Exco InTouch (excointouch.com) has used its applied phone
technology to send SMS text blasts among client databases to promote study awareness.
Cetero recently made the Website at the company’s Toronto clinic smart-phone friendly. Called
sneezetoronto.com, the site provides detailed information on trial oppotunities at the facility, as well as
live chat capability, where prospective patients can communicate directly with a call center
representative.
iPhone and iPad applications in patient enrollment have grown in number. For example, in March, PPD
launched its Clinical Trials Mobile application for use on those devices to help potential clinical research
participants and investigators find trials across various therapeutic areas. The application provides
keyword search menus, allowing users to search the U.S. National Library of Medicine
ClinicalTrials.gov database of more than 100,000 clinical studies. Users can customize their search by
location, gender, age and other search criteria. The application also provides details about specific
trials, such as eligibility criteria, trial locations, and contact information.
E-recruitment methods are generally considered to be more cost-effective than traditional media tactics
for outreach. In most cases, using digital tools to generate early milestones, such as respondents and

pre-qualified referrals, is more cost-efficient than traditional tactics across many therapeutic areas,
according to Scott Connor, VP of marketing for patient recruitment provider Acurian (acurian.com).
“However, e-recruitment alone will not produce enough volume to fill the enrollment needs of most
large studies,” Mr. Connor says.
Still, employing online advertising for enrollment can provide a major boost to target goals, if performed
properly. When creating content for Web recruitment, it is crucial for sites to first consider the call to
action, as well as the value proposition of a trial and how to best engage the Internet user, according to
Abbe Steel, executive director of trial enhancement, United BioSource Corp. (unitedbiosource.com).
She says messaging should be crafted around a strong set of medical and lifestyle keywords and
compelling text. Ms. Steel notes that studies have found that people generally need to hear messages
at least eight times to take action.
It also may take several more advertising impressions to get the attention of someone browsing online.
Ms. Steel, who leads a team at UBC focused on designing multimedia initiatives to identify and enroll
clinical trial patients, says advertisements that are credible, clear, an provide useful medical information
typically have better response rates than the more flashy advertisements.
Though no official regulatory guidance exists yet, existing rules covering the proper and ethical conduct
of digital recruiting methods are similar to those governing traditional media outreach. For example, the
process to ensure institutional review board-approved messaging is no different than the process for a
direct mail letter or TV spot, in that the online advertisement must go through the same central or local
IRB channels.
“The advantage of online is that you can produce multiple versions cheaply, and any changes from the
IRBs can be implemented quickly,” Mr. Connor says. “But there should be no circumvention of the IRB
process.”
Online advertisement can also be easier and faster to track audience response compared to TV or
radio spots.
Many drugmakers, however, remain cautious when navigating opportunities in e-recruitment,
particularly around social media, as FDA has been slow in releasing promised guidelines on the use of
this communication by drugmakers. After originally planning to issue guidelines in 2010, the agency
delayed the release again early this year, now estimating that the guidance will not be ready until 2013.
Regardless, experts in patient recruitment believe FDA’s advice will likely touch very little on clinical
trial practice, but serve more to address commercial concerns that social media interaction with
patients could breach direct-to-customer promotion rules.
“I believe guidance will be nebulous at best, and it will be iterative in nature,” Mr. Connor says.
“Whether or not this heightens or reduces sponsor concerns remains to be seen. It will come down to
each company’s compliance and legal interpretation, and appetite for risk. If the guidance even
remotely touches on patient recruitment, I will be surprised. I think the big focus will continue to be on
the commercial side because big money always commands the attention.”
Guidance uncertainty aside, Mr. Connor says existing regulations require that best practices, privacy
policies, and regulated communication standards be consistently applied regardless of the online or
offline nature of the recruitment channel.

Social spotlight
Although there are several forms of digital media recruiters can tap in the search for clinical trial
participants, none have captivated and cautioned companies more than social media.
With the numbers of people seeking health information online increasing at a rapid clip, sponsors and
CROs are using additional avenues of outreach to widen the recruitment funnel, with some exploring
the use of popular social networking channels such as Facebook, Twitter, MySpace, and YouTube,
among others. These communication platforms provide alternative and more open avenues to reach
and in some cases interact with potential patients, to support and inform patients, identify patient
influences, and make study information easily accessible. In recent years, patient recruitment
companies in particular have had success creating social network advertisements, where companies
buy demographic placement that match the requirements of the clinical studies they are looking to
enroll.
Some recruitment organizations, such as Acurian, also provide their own proprietary social media
interface designed to raise clinical trial awareness, boost patient access to relevant trials, and expand
sponsors’ access to interested patients.
A recent study by the Pew Research Center (people-press.org) indicates that 61 percent of american
adults look online for medical help, suggesting greater use of social media in this area. In turn, life
sciences companies, realizing the opportunity for new audiences, are increasingly pursuing social
media on a strategic level, though the adoption has been slow. More than 65 percent of industry
professionals say their company uses or plans to use social networks at a company level in some
capacity and 73 percent expect the budget for them to increase in the next three years, according to a
recent report by Deloitte. At the same time, however, the survey did reveal that 35 percent of life
science companies report no plans to use social media in that capacity.
The latter figure is largely attributed to still-undefined FDA guidelines, consumer privacy concerns, and
a lack of a clearly demonstrated return on investment from social media. Another drawback is the risk
of data contamination. Although access to engaged and active patients is unparalleled compared to
other recruitment outlets, the dialogue between community members in social media networks is not
controllable. This can result in discussions where a participating subject influences others subjects,
chatter that may also skew a potential patient pool.
Recruiters, meanwhile, who under current rules must have every post or message IRB approved ahead
of time, are limited in the management of the dialogue. Having to resubmit even slightly changed
message scripts can add significant time to a social media program and create other cumbersome
issues, leaving some choosing to avoid engaging in dialogue with patients on these sites.
“We can only push information out,” says Diana Anderson, Ph.D., president and CEO, D. Anderson &
Company (dandersoncompany.com). “Let’s say two patients are involved in the same trial, and they
figure that out, and start talking about placebo control or adverse events or other issues. That could be
a challenge for us. ... We are in the business of tightening awareness of our trials through social media
and then linking them in most cases back to our Website. They can then opt-in to screen, get further
information, and so on.”
That tactic has resulted in as much as a 400 percent increase in traffic to D. Anderson’s Website,
according to Dr. Anderson, whose company was acquired in March by Imperial (imperialcrs.com), a
provider of supplies and printed materials to investigative sites in 80 countries.

Even as Website traffic may benefit from social media outreach, accurately forecasting and measuring
return on investment from the practice has been a tricky task, with little case model data available.
In efforts to uncover markers for social media success, Blue Chip Marketing launched an online survey
earlier this year to collect patient insights into how social media can be most effectively used in patient
recruitment. The survey seeks to better understand which social media and health-related sites users
most frequently visit; which conditions they research online; reasons why users would participate in a
clinical trial; and from which online portals users would feel most comfortable engaging in clinical trialsrelated
dialogue.
Stanton Kawer, CEO of Blue Chip Marketing, says the company has accumulated large amounts of
historical data on how different media approaches influence patient recruitment, but such data specific
to social media has never existed.
“We had to bridge that gap very quickly if we were going to be best practice in developing an
understanding of insights quickly that will help us deliver success for social media,” Mr. Kawer says.
“We look at it as it’s not any different than broadcast television, than other forms of media. But we need
to have that data so that we’re able to provide a proper risk assessment for the pharmaceutical
sponsors.”
Blue Chip Marketing, which in crafting its survey, reviewed and analyzed hundreds of social media
communities, has not formally started tabulating the results, but has uncovered preliminary data. As of
last month, 85 percent of respondents said they were engaged in their healthcare or health related
social media community, either daily or weekly. In addition, 40 percent of those surveyed indicated that
they are not just reading posts, but are posting their own information and sharing a dialogue with
others. About 20 percent of the respondents to the survey said they have already participated in a
clinical trial. Ms. Slutzky notes that this figure is almost three times as much as the national U.S.
average for participation, which is about 7 percent of the population.
“It’s all about making sure that our programs are grounded in facts and insights and what will be used
and what will be efficient at the sites,” Mr. Weisman says.
The collection of metrics from online campaigns using social media, while potentially costly, are
valuable in identifying which disease indications such initiatives might work best in.
The first step, according to Ms. Steel, involves analyzing how similar populations are engaging online –
what information is being exchanged and how it is being communicated. The multiple sclerosis
community, for example, is widely known for its active social networks, which use online communities
to share information on a wide range of topics, from comparing side effects to lifestyle tips.
Popular nonprofit groups such as PatientsLikeMe (patientslikeme.com), a health-data sharing
company, provide a social media forum where patients can share and learn real-world, outcomesbased
health data. Resulting discoveries can be significant for clinical research. For example, a recent
observational trial run by PatientsLikeMe with members of its network found that lithium did not slow
progression of amyotrophic lateral sclerosis, the deadly neurodegenerative disease. The study,
according to published reports, was based on data contributed by 596 patients with the disease. The
study showed that lithium did not alter progression of the condition, contradicting a study in 2008 that
suggested such a benefit was possible.
Large pharmaceutical companies including Pfizer Inc. (pfizer.com) and Novartis (novartis.com) have

purchased advertising space on Websites such as patientslikeme.com.
“It’s important to determine which groups, forums, and networks matter most to your study’s target
population,” Ms. Steel says. “For example, does your patient population belong to a Facebook page?
Are they active in a patient advocacy group? Are they looking for a new treatment or drug delivery
system?”
If it is determined a patient population is engaged online, sites should then create an online presence
long before beginning study outreach, a process that takes two to three months, according to Ms.
Gonzales. She says that presence could involve simply providing general medical kits, article links, and
notifications on conferences or medical meetings in the area.
“If you’re posting that information, you’re creating that trust,” Ms. Gonzales says. “You need to gain that
traction first and then you’ll have an audience through which to submit study awareness messaging. If
you don’t have anyone to talk to yet, if no one is following you, you’re speaking in a vacuum.”
Ms. Gonzales and others caution, however, that although opportunities from social media may
potentially transform recruitment practice, the tool is not a panacea, but only one component in a
overall digital-based strategy. With still uncertain privacy and ethical boundaries and little proven data
on overall effectiveness, social media’s true emergence as a patient recruitment aid may take a while.
In addition, sometimes overlooked is the potential extra burden social media programs may place on
sites, with increased referrals and issues around a site’s willingness and ability to follow up with the
patients and to convert referrals into study patients. Social media may seem like a relatively costeffective
method in creating increased trial interest, Dr. Jones notes, but to be successful, there will
need to be an interface put in place to manage referrals. For example, study Websites with
prequalifying functionality, interactive voice and video response systems, or traditional call centers may
need to be employed to ensure that the referrals being sent to sites are of a high quality.
“The devil is in the details after a social campaign launches,” Mr. Connor says. “Neither sites nor CROs
have this kind of post-launch expertise. The fundamental issue with sites is, will they see a pre-qualified
referral generated in a timely fashion, regardless of where that referral came from? That is the linchpin
of a successful recruitment effort.”