The Crisis in Clinical Trials: Recruitment AndEnrollment

S T R A T E G I C E - B O O K S T O M A K E Y O U R J O B E A S I E R

✦ 80% of clinical trials fail to meet enrollment timelines

✦ 50% of research sites enrol l one or no patients ✦ $8 million in lost revenue for each day a drug is delayed

“Despite widely publicized contro-versies that have damaged the

public’s trust and confidence in the credibility of stakeholders in

clinical research, the desire for bet-ter health and well-being has not

diminished. The public has demon-strated remarkable tolerance for

mistakes. A unique but closing win-dow of opportunity exists for drug-makers to build collectively on this foundation in order to restore public

confidence and trust.”

—Kenneth Getz ,The Center for Information & Study on Clinical Research and Participation (CISCRP)

Patient Matters

Jean Paty, PhD

Many of us involved in the biopharmaceutical and medical device industry do not often consider regulators the people who lead the charge. Times have changed. FDA took the first step in 2009 in pushing us to focus on the patient. How? By releasing the final "Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" (or PRO guidance). FDA had previously released the draft version of this guidance in February 2006.

So, what's the big deal? FDA releases Guidance for Industry docu-ments all the time. This PRO guidance was different: it has almost single-handedly driven our industry to take note of the patient—to listen, understand, and document the patient's perspective during

FORWARD

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DISCUSS: A NAME BY ANY OTHER

1. Are those being tested in clinical trials volun-

teers participants, patients?

2. Is the term ‘subject’ derogatory? Most would

now use the term participants, and is ‘research

participants even better?

3. Patients sounds good. It sounds kinder. It sounds

like you are helping a world of people. True? A

predetermined and limited number of people se-

lect themselves into a trial. If you call them a pa-

tient, they think they are a patient—a person

seeking care. A clinical trial is research. And par-

ticipating in research has its own rules. 

4. Am I arguing semantics?

Lisa Henderson, Editor in Chief Applied Clinical

medical product development. The momentum started building fol-lowing the release of the draft guidance in February 2006. In the almost three years between draft and final guidance, FDA regularly and actively communicated its key message: listen to the patient.

Since following the release of the final version of the guidance, sig-nificant strides have been made toward focusing on the patient during product development. Concretely, what has happened? The answer lies in how the specific recommendations in the guid-ance have had an impact on product development strategy. Here is how the story unfolded...

The guidance delineates FDA's current expectations for PRO in-struments (that capture data directly from the patient with no inter-pretation by a clinical professional) that will be used to support la-beling language in medical products. The recommendations from FDA are based upon the discipline of developing PRO instruments in psychology and other areas—psychometrics. There is nothing new or surprising in terms of what should be done to develop and evaluate PRO instruments.

The PRO guidance has legitimized PROs, elevating their impor-tance in product development planning. The mere fact that the FDA finalized this guidance has given a clear message to the in-dustry that the patient perspective is important enough to be a for-mal part of the regulatory-based communication of a product: the label. This has led many pharmaceutical companies to re-evaluate

their hierarchy of endpoints. In the past year, we have seen over a dozen pharmaceutical companies that have elevated PROs to be alongside other primary or key secondary biomarkers or physician-assessment endpoints. Such companies are seeking PRO-based labels for their new products. They have worked closely and collaboratively with FDA on the PRO instruments that will support these labels. These companies are taking advantage of the opportunity to clearly communicate the value of their prod-uct to the people who matter most—patients.

FDA almost single-handedly drove the

industry to take note of the patient, to

listen, to understand, and document

the patient's perspective during

medical product development

The elevation of PROs in clinical programs to endpoints that will form the basis of labeling claims had a follow-on effect within phar-maceuticals. When an endpoint, or class of endpoints, is regularly part of the label plan, or target product profile, it starts to be part of the strategic planning for pipelines within. In fact, some of the largest pharmaceutical companies have subsequently made con-sideration of PRO endpoints as part of their documented process for developing a product strategy. PROs are strategic. The patient benefits.

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It Takes An Army

By Jim Kremidas

Patient recruitment plays a major role in establishing the objectives and the ultimate success of clinical trials. Yet, targeting the right pa-tients and retaining their participation is one of the greatest chal-lenges currently facing the biopharmaceutical industry.

Traditional recruitment methods have proven inadequate, with the majority of trials failing to enroll a sufficient number of patients in a timely fashion. As the biopharmaceutical industry continues to face challenges such as increasing costs, reduced productivity, and shrink-ing pipelines, it can ill afford costly delays associated with recruiting and retaining patients for clinical research.

Historically, the responsibility for patient recruitment primarily be-longed to investigator sites. Today, sponsors and contract research or-ganizations (CROs) are partnering with sites and a broad range of stakeholders, including operations, site monitors, site staff, and re-cruitment specialists, to drive enrollment. Sophisticated planning and coordination among all parties is necessary in order to successfully carry out effective and efficient patient recruitment.

Strategies & Solutions

RECRUITMENT

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DISCUSS: WHAT’S TO BE DONE

1. Challenges to patient recruitment currently facing the

biopharmaceutical industry

2. The role of the sponsor and CRO in recruiting and re-

taining patients

3. The role of investigator sites in recruiting and retaining

patients

4. Communication strategies that best support trial sites

in patient recruitment efforts

5. The importance of each member of the trial team carry-

ing out his or her role for the benefit of the entire trial.

What’s Different

Patient recruitment is critically important to the health of bio-pharmaceutical research activities, and an area of growing con-cern. Challenges to patient recruitment have been exacerbated in recent years by a number of factors:

A dramatic expansion in the number of trials being con-ducted, which has heightened competition for patients.

More trials, same the number of new investigators:

Between 2000 and 2007, the volume of studies has in-creased by approximately 15%, and the number of new investigators has declined by 10%.

Increasing study complexity and eligibility cr

Over the past decade, the average eligibility criteria for clinical trials have increased by 58%, while volunteer patient enrollment rates dropped by 21%, retention rates fell by 30%.

Competitive Imperative

With a more competitive landscape, advances in recruitment practices must be implemented if the biopharmaceutical indus-try is to meet the growing demand for patient participants. In large part, that will require:

A thorough re-evaluation of the roles and responsibili-ties of trial professionals;

Each member focusing on mastering his or her particu-lar area of specialty in the service of the larger goal of the trial.

Get Tight With Your CRO

The sponsor, and by extension the CRO, plays a key role in facility ating a clinical trial site's patient recruitment activities.

Establishing protocol criteria. Overly complex or unrealistic protocols are one cause of trial delays and have a negative and costly impact on the ability to enroll and retain patients. The feasibility of a trial, therefore, must be carefully examined to ensure that assumptions made early on are supported by a com-prehensive set of data collected from multiple sources.

Supporting chart review. Allowing investigator sites to conduct a thorough review of patient charts as part of the planning proc-ess is an important step in identifying and enrolling appropriate trial participants.

Compensate investigator site staff for the process of carefully reviewing patient charts and evaluating them against protocol criteria requires a significant commitment of time on the part of investigator site staff. If the job is to be prioritized, the sponsor/CRO should consider compensating staff for this impor-tant task. Providing financial support for the time it takes sites

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to mine their medical charts for potential trial volunteers makes it possible for sites to invest the resources necessary to thor-oughly carry out chart reviews and focus on rapidly recruiting the most appropriate patients.

Use of EMRs. Leveraging electronic health data is a critical tool for establishing more sophisticated patient recruitment strate-gies throughout the industry and will play an increasingly sig-nificant role in helping to coordinate the efforts of trial teams as they are adapted across the medical profession.

EMR system can conduct feasibility assessments and identify appropriate patients. Some EMR vendors, for example, have the capability to write a trial protocol query that an investigator site can run against their patient database to identify potential trial participants. This can be a very effective way of identifying patients who might be appropriate for the trial, and is a tool that the sponsor should consider.

Using site communication materials. Approximately 69% of non-participation in clinical trials is the result of a lack of awareness that a trial is even taking place. That underscores how critically important effective communication is to the suc-cess of patient recruitment, and ultimately, to the trial itself.

Get theTrial Message Out

First, the sponsor/CRO should provide each investigator site with pa-tient communication materials. Brochures, posters, placards, and pocket tri-folds can accomplish two important objectivKeep the study top-of-mind for trial site staff so they remember to offer the study as an option for the patient

• Help facilitate communication between staff and patient

• Write without medical jargon and in terms that patients can easily understand, communication materials at the trial site play an impor-tant role in helping patients become more informed about what it means to be a trial volunteer.

• A well designed communication tools drive a 20% to 60% in-crease in consented patients willing to be screened. It was found that there is a greater benefit to distributing these materials early in the trial.

Your Boundries

Supporting sites in the effort to identify and recruit patients from out-side of a practice also relies heavily on well-crafted patient communi-cations and is an area in which sponsors/CROs should take an active role.

Today, it's more important than in previous years to help sites reach beyond their practices to find patients. Increased competition for pa-tients and recognition that advertising is not typically an area of ex-pertise at the site level requires communication professionals to join the team and establish the most effective channels by which to reach the patient population of interest.

As a starting point, marketing research is necessary in order to un-cover the key issues and questions patients have about participating in a trial. This plays a critical role in the development of appropriate messaging aimed at encouraging and enabling patients to seek more information about participating in a clinical trial.

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Sponsors/CROs can then make it easy for sites to advertise by sup-porting them with media buying expertise to ensure that the most ef-fective form of media to attract the target patient market is being de-ployed. To facilitate media buying, some CROs and sponsors provide sites with an advertising tool that allows investigators to select media online and then access the expertise of professional media planners and buyers to negotiate its purchase. Additionally, tracking the results of the campaign can be used to drive process improvement on an on-going basis.

The study coordinator or investigator

isn't necessarily the most effective at

choosing media or creating advertising

messages that are noticed by the target

patient population.

In some cases, an advertising account is established so that trial sites simply draw on a fund rather than submit invoices for each media buy. Sponsors/CROs can make available to sites opt-in databases of patients interested in participating in trials and help the sites pre-screen those patients ensuring only the most qualified applicants are referred. Pre-screening can be done by a call center or online ques-tionnaire that captures self-reported patient information. While it's not possible with this method to address all inclusion and exclusion criteria, basic parameters such as patient age and medications can be covered to improve the likelihood that the patients referred are strong candidates for the study.

Role of Investigator SitesNaturally, the investigator sites must also play an active role in recruit-ing patients for the trial they will conduct.

Standards of care information. Physician investigators, specifically, play a critical role in helping sponsors/CROs understand how pa-tients interact with the healthcare system and how they will move through a particular study. This kind of "on-the-ground information" is essential to sponsor/CRO efforts to establish protocols that are less complicated and maximize convenience for both patients and site coordinators. Investigators and clinical coordinators should also be involved in reviewing a draft of the study design and provide feed-back early on so important adjustments to protocols can be made. It is important to ensure that assumptions are based on data rather than anecdotal experiences.

Contributions to communication/education. By talking openly with patients early on about participating in a clinical trial, sites can so-licit feedback to help in the development of educational materials that specifically address patients' most pressing questions and con-cerns. It also provides an opportunity for site staff to educate patients about the specific benefits of participating in a clinical trial. For ex-ample, that their own health will be closely monitored, or that it's an opportunity to contribute to a body of scientific knowledge that may ultimately help treat other individuals who share their illness.

Leveraging recruitment tools. It's important for sites to recognize and leverage the tools and expertise provided by sponsors/CROs. Of-ten, investigators go it alone when it comes to recruiting patients, at-tempting to market and advertise the study themselves. Expertise re-

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garding how best to implement some of the necessary activities for successful patient recruitment is available through sponsors/CROs and should be utilized. The most effective sites work collaboratively with experts and adapt patient recruitment methods to fit their envi-ronment. They do not attempt to master them on their own.

Volunteer follow up. Following up with patients who come to the study through media or opt-in databases is another critically impor-tant aspect of successful patient recruiting for investigator sites. A fail

ure to contact patients in a timely manner reduces participation great-ly—one study found that sites that waited to follow-up with patients experienced a 68 percent decrease in participation as compared with sites that followed up within one day of referral. 6

Once recruited for a study, it is important for the investigator site to establish and maintain a relationship with the patient and to manage that relationship proactively. Study volunteers, after all, are giving up a lot of personal time and may be making a significant sacrifice. It's important that investigators keep this fact in mind and treat trial vol-unteers with a customer service orientation.

Hang Together As A TeamSponsors and CROs are increasingly working as partners with a range of research professionals to recruit and retain patients for clini-cal trials. In today's market, the responsibility for doing so cannot fall to one group of stakeholders, but rather, must be a team effort with all participants doing their job well and in coordination with each other. We all feel we understand what advertising is, for example, because no matter our profession, it's something we're all exposed to in our daily lives. But it's important to keep in mind that the study co-

ordinator or investigator, who plays a critical role in establishing rela-tionships with patients, isn't necessarily the most effective at choos-ing media or creating advertising messages that are noticed by the target patient population. With access to individuals professionally trained to carry out these functions, engaging their expertise in-creases the likelihood of a successful recruitment effort.

All trial stakeholders, from physician investigators to site monitors, communications experts to CRO monitors and managers, have an impact on enrollment. All parties must be clear about their specific responsibilities and deliver on their objectives in order to effectively recruit qualified patients and for the entire trial to be a success.

J

One of the greatest mistakes made

during patient recruiting comes when

professionals from all areas of a trial

step too far beyond their area of

expertise and attempt to carry out a job

that someone else on the team is better

trained to do.

Jim Kremidas is Vice President, Global Head of Patient Recruitment, Quintiles, 4820 Emperor Boulevard, Durham, NC, e-mail:

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—Kenneth Getz ,The Center for Information & Study on Clinical Research and Participation (CISCRP)

Engagement: eMedia

“A unique but closing window of opportunity exists for drug-

makers to build collectively on this good will in order to restore

public confidence and trust.”

Efforts to educate but also to change the perception of what it means to participant in a clinical trial in this YouTube video

A Success Story: Mayo Clinic

By Marylyn Donahue, Pharmaceutical Executive Magazine

Recruiting patients for clinical trials is increasingly difficult, espe-cially in the US, where many people remain uninterested in participa-tion. In many cases, drug makers are also hard-pressed to find ‘treat-ment naive’ patients - those who are not on other meds.

“Inefficient patient recruitment is among the primary causes for trial failure….We assume that the patients will be coming to the clinical centers after the announcement about a particular trial and there are no queues in particular regions of the patients with a specific disease waiting for this trial,” says Prof. Dr. Vladimir V. Anisimov Director, Re-search Statistics Unit GlaxoSmithKline, who believes the solution is a robust predictive methodology for recruitment projection and model-ing in clinical planning.

And he may well be right. Finding qualified patients for clinical trials costs pharma companies millions of dollars and often sets them months, even years, behind schedule. And most seriously, can deny suffering patients much-needed medications.

We took look at a successful instance of using social media for pa-tient recruitment for a pilot study on a rare heart disease at the Mayo Clinic last summer; a general overview of the pros and cons of using social media for trial recruitment.

Social Media and online networking proved to be a valuable tool for recruiting study participants to study a rare disease last summer at the Mayo Clinic.

Social ePatient Recruitment Media

SOCIAL MEDIA

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DISCUSS: HOW TO MAKE IT WORK

1. Despite widely publicized controversies that have dam-

aged the public’s trust and confidence in the credibility

of stakeholders in clinical research, the desire for bet-

ter health and well-being has not diminished.

2. The public has demonstrated remarkable tolerance for

mistakes. A unique but closing window of opportunity

exists for drugmakers to build collectively on this foun-

dation in order to restore public confidence and trust.”

Through patient-run websites dedicated to heart conditions and women's heart health, a team of Mayo Clinic cardiologists led by Sharonne Hayes, M.D., reached out to survivors of spontaneous coro-nary artery dissection, also known as SCAD, a poorly understood heart condition that affects just a few thousand Americans every year.

The Internet, however, has opened up

a new source of potentially willing

participants. If social media and online

forums like Facebook, Twitter, and

Foursquare, can reconnect you with

your friend from first grade then why

not try it for clinical trial recruitment?

A SCAD survivor inspired the pilot study. The woman approached Dr. Hayes asking how she could spur more research into the unusual condition. Dr. Hayes' research team then asked the survivor to help recruit participants through an online support community on the website for WomenHeart: The National Coalition for Women with Heart Disease, The SCAD survivor and Dr. Hayes already were affili-ated with the site.

Much discussion among researchers has taken place about how study recruitment through social media and online networks could help assemble large and demographically diverse patient groups more quickly and inexpensively than they could using traditional out-

reach methods, but just how and how well it would work has been in question.

The Mayo Clinic patient-initiative research and their generous shar-ing of their process and procedure definitely supplies some answers. A report posted online (and quoted at length in this article) in the Sep-tember issue of Mayo Clinic Proceedings gives a detailed accounting of their processes, successes, and limitations.

"Patients with rare diseases tend to find one another and connect be-cause they are searching for information and support," says co-author Marysia Tweet, M.D. "Studies of rare diseases often are underfunded, and people with these conditions are quite motivated."

SCAD is a traumatic cardiac event that often induces heart attack, but physicians have no clinical studies on which to base treatment plans, says Dr. Hayes, lead author of the study and founder of Mayo's Women's Heart Clinic.

"This is a completely different research model than Mayo Clinic is used to," Dr. Hayes says. "Investigators here typically rely on the stores of patient information from the clinic. This was truly patient-initiated research."

The study landed 18 participants in less than a week, six more than could participate in this pilot of 12 patients. The remaining volun-teers are eligible to participate in a new, larger study based on the initial study's success.

The new research sought patients through conventional and social media outlets and aims to build a virtual registry and DNA biobank of up to 400 SCAD survivors and their relatives. The database will help physicians conduct more detailed analyses of treatment strate-

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gies and factors that affect prognosis and better understand the possi-ble genetic basis of some SCAD cases.

Through its Office of Rare Diseases Research, the National Institutes of Health tracks 6,000 to 7,800 rare diseases such as SCAD that af-fect fewer than 200,000 Americans. NIH experts can only estimate the number of rare diseases because there's not enough data to know how many patients have them, let alone how to study or treat them.

"Patient leadership in this is huge," says study co-author Lee Aase, di-rector of Mayo Clinic's Center for Social Media. "Designing research protocols to study rare diseases and then recruiting enough patients to participate is extremely difficult for busy physicians, but patients with rare diseases are highly motivated to see research happen."

The study landed 18 participants in less

than a week, six more than could

participate in this pilot of 12 patients.

The remaining volunteers are eligible to

participate in a new, larger study based

on the initial study's success.

The report goes on to detail the pilot study setup: “After being ap-proached by several members of an international disease-specific sup-port group on a social networking site, we used it to identify patients who had been diagnosed as having at least 1 episode of spontaneous coronary artery dissection and recruited them to participate in a clini-

cal investigation of their condition. Medical records were collected and reviewed, the original diagnosis was independently confirmed by review of imaging studies, and health status (both interval and cur-rent) was assessed via specially designed questionnaires and vali-dated assessment tools.

“Recruitment of all 12 participants was complete within 1 week of institutional review board approval (March 18, 2010). Data collec-tion was completed November 18, 2010. All participants completed the study questionnaires and provided the required medical records and coronary angiograms and ancillary imaging data. Identifying and recruiting study participants with rare conditions such as SCAD can be a formidable challenge because no single medical center has ade-quate experience and/or patient volume. A formal multicenter regis-try will ultimately be necessary to recruit patients early in the acute phase of their condition, and subsequently randomized clinical trials may become feasible. Until it is created, however, this unique model involving self-organized patients with SCAD provides an excellent option for a virtual multicenter registry. The rapid enrollment of par-ticipants in this pilot study through a social networking platform sug-gests a way to harness patient enthusiasm and organize studies that have been heretofore impractical.

“Data that could be collected in this manner include clinically rele-vant information about demographics, natural history in survivors, and treatment patterns. We found the personal narrative prepared by participants about their disease and health care experiences to be ex-tremely helpful in filling in gaps in medical history, clarifying time lines and generally complementing the medical records in a manner similar to obtaining a face-to-face clinical history. As in other regis-tries, findings can generate hypotheses and future inquiry. Our report

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serves as a proof of concept, and extending enrollment to the almost 100 women with SCAD currently on Inspire.com will produce the largest SCAD registry to date and allow development of an imaging and DNA database to complement the retrospective assessment. Moreover, in the future this process could be extended via online sur-veys and development of electronic centralized data repositories with direct health record data transfer, assuming data security and Health Insurance Portability and Accountability Act compliance could be ensured.

Social networking tools have had

important health and humanitarian

effects ranging from crowd-sourced

epidemiology studies to earthquake

relief.

“Obtaining complete medical records is crucial for this type of re-view. Our participants were highly motivated to provide all re-quested records. We were impressed with the successful collection of original diagnostic coronary artery imaging for review in all of our pilot participants despite their geographic diversity, the challenges of our medical record retrieval system, and the lack of participants' pre-existing clinical relationship with the investigators. Several partici-pants asked their personal physicians to contact us to confirm our data needs, and 3 potential study participants' physicians contacted an investigator (S.N.H.) at the patients' request to ensure that our study was “legitimate.”

“Given the possibility of Internet scams and the fact that the patients had not yet received communication directly from the Mayo Clinic study team, this reflects appropriate caution. In future studies, post-ing key information available on Mayo Clinic's Web site for institu-tional clinical trials before the notice goes “viral” on the patients' so-cial networking site will be important.

“As an offshoot of and surrogate for in-person disease-specific sup-port groups, patients have organized online to share experiences and provide mutual support for well over a decade. The best-funded and most prominent disease-focused platforms tend to aggregate around more common conditions such as diabetes mellitus and breast can-cer.

“In-person support groups for conditions as rare as SCAD prior im-practical if not impossible. On the basis of current estimates of preva-lence, only a few dozen SCAD survivors are likely to reside in even a large metropolitan area. An online site with no geographic limita-tions.

Social networking tools have had important health and humanitarian effects ranging from crowd-sourced epidemiology studies to earth-quake relief. Projects such as Ushahidi ( have enabled populations affected by a mass incident to easily pool and organize their knowl-edge. New York University professor Clay Shirky calls platforms like these mechanisms for harnessing society's “cognitive surplus.” Our approach differed from these projects in that it applied social tools not in headline-grabbing localized events such as pandemics and earthquakes, but rather to an unusual condition unnoticed by the broader population because those affected are widely dispersed.

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Building patient registries has traditionally been costly, particularly for rare conditions in which multiple centers are needed to achieve sufficient size. Busy clinician investigators also have many compet-ing demands for attention that may hinder their ability to organize a registry, which requires outreach to other centers and convincing peers to cooperate, adding organizational overhead costs for coordi-nation. This pilot study strongly suggests that social networking tools can catalyze community action and that the energy and commitment of affected patients can overcome inertia and reduce registry costs. The singular motivation and focus of patients with little-understood conditions, combined with the natural organizing framework in a so-cial networking site, may significantly improve the timeliness and cost-effectiveness of research in these conditions.

Women, younger patients, and patients with uncommon medical conditions for which no consensus exists on etiology, treatment, and prognosis might be expected to search more broadly for answers to their questions on the Internet or through other less conventional sources of medical information compared with men, older patients, and those with more common disorders. After our study was under way, we were contacted by a number of persons with SCAD or their family members about clinical and research questions. They were not members or aware of the original Internet networking group. Al-though not systematically assessed, these persons reported that they had heard of our SCAD research from a variety of sources, including specific Internet search activity, personal blogs, Facebook, “word of mouth” through other SCAD patients, and Mayo Clinic Web sites. This suggests that the inherent interconnectivity of the Internet, com-bined with a strong drive to acquire hard-to-find health information, can be leveraged even more extensively in the future.

“Using lessons learned from this pilot study, we will expand our study to recruit eligible participants via standard methods as well as through communication with this and other heart disease-based so-cial networking sites. Ultimately, we aim to provide a higher-powered, descriptive database including prospective biospecimen and DNA collection, physical and mental well-being assessment of participants, and comparisons with age- and sex-matched controls. With collaborating centers, we plan to develop a prospective trial to further guide short- and long-term treatment because, as demon-strated by our cohort and others, significant variability exists in the short- and long-term management of SCAD.”

As an offshoot of and surrogate for in-

person disease-specific support groups,

patients have organized online to share

experiences and provide mutual

support for well over a decade.

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Patient Recruitment An Uphill BattleAll-told the Mayo Clinic’s pilot study recruitment using social media and online networks not only helped researchers assemble large and demographically diverse patient groups more quickly, but also they did it less expensively than they could through other means.

“This study is a prime example of patient-initiated research that could be used by other health care professionals and institutions,” conclude the authors of the Mayo report.

But can the Mayo Clinic’s pilot study really be used “by other health care professionals and institutions?”

Was the success of their social media recruitment so easily translat-able? Or was their pilot study the result of a perfect storm—A series of factors coming together to make it just the right opportunity for so-cial media recruitment, and anything but commonplace.

What made it Perfect Storm?In an article in Digital Strategy & Patient Recruitment for Clinical Tri-als, Rahlyn Gossen examines six key patient recruitment factors that resulted in the Mayo’s pilot study’s success and a perfect social me-dia fit. (Not to be overlooked in all of this is the Mayo Clinic’s sophis-ticated, savvy, and deep appreciation of social media).

Gossen, a former clinical research coordinator who now has her own firm, Rebar Interactive, lists these six factors (see box) (Read Gossen’s analysis here

“In some cases, clinical research professionals can mimic the factors contributing to Mayo’s success,” says Gossen. “But in most cases, the possibility for successful social media recruitment will largely be

Social Media

ONLINE ENROLLING

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A PERFECT STORM

1. Research focusing on a rare disease

2. Concentrated and organized patient population

3. Patient-initiated research and ownership for success

4. Favorable demographics for patient recruitment via so-

cial media

5. A concentrated and organized patient population

6. Patient-Initiated Research and Ownership for Success

7. Widespread Positive Brand Awareness (Mayo Clinic)

8. Lack of geographic constraints

the result of static factors like therapeutic indication, patient popula-tion, study design, and geography.

But can the Mayo Clinic’s pilot study

really be used “by other health care

professionals and institutions?”

“Before undertaking a social media campaign for patient recruit-ment, it’s imperative that clinical research professionals identify perti-nent variables and determine whether those variables are well-aligned with a social media recruitment campaign,” says Gossen.”

It is also imperative that whomever is behind the effort is equipped with the social media skills enjoyed by the Mayo Clinic (You only have to go to their Website for a glimpse of their media expertise and sense of design). They must also be motivated by more than just a de-sire to sell a social media service.

“The reality is that, in many cases, patient recruitment via social me-dia will be an uphill battle,” says Gossen. “But all is not lost. You can still recruit patients who frequent social media sites with advertising on those sites, thereby eliminating the challenges of patient recruit-ment on social media websites.”

Gossen told Applied Clinical Trials that it is important to distinguish between social media and advertising on social media platforms. “This is an area where I find there to be some confusion, and that confusion tends to muddle the discussion about social media in pa-tient recruitment,” she said. “Social media is by nature a dialogue and requires a very different strategy and skill set than online advertis-

ing, which is more of a one-way broadcasting medium. An example of this distinction in practice is the difference between, say, putting up a Facebook page and conversing with those who are commenting versus putting up ads on Facebook. This distinction, I've noticed, is unclear regarding terminology.”

Social media is just that social, and it requires long term engagement between participants that runs counter to say a study specific goal and just putting out the word from outer space that’s there’s a trial go-ing on.

Whereas a tactical advertisement on Facebook can be targeted among the site’s hundreds of millions of users. Its offerings for adver-tisers also can be highly targeted to specific geographic areas. And with such a large population, Facebook can reach a high percentage of potential patients across all levels of income and education. Tradi-tional media can’t even touch those results.

Groups like mePeer influence to generate interest in participating in a trial is another method to generate trial recruitment. PatientsLikeMe hosts all kinds of disease communities where patients can track their medications, symptoms, and health outcomes and can learn from other patients whose profiles resemble their own. It allows the industry to look at aggregated data from its communities. And now it allows them to partner with pharma companies to announce clinical recruitment trials through its online communities. Other patient sites like Inspire and armyofwomen.org do the same.

Nevertheless, the uphill battle in social media recruitment Gossen referred to earlier was confirmed last spring by a survey conducted by Blue Chip Patient Recruitment and shouted out by Ed Silverman at

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Pharmalot. Silveman adds a caveat: “The company is a division of Blue Chip Marketing Worldwide, a marketing agency that is, of course, attempting to promote its expertise by conducting the survey and disseminating the results as a worthwhile snapshot.”

Nonetheless the study found: Of 179 adults, who were queried through postings in online health communities, 84 percent have never participated in a trial. Twenty-two percent would enroll if a drug offered a cure and 21 percent if they could help find a cure.

Online or offline, safety also presented an issue to the survey partici-pants:

• 41 percent reported that trial safety is a primary concern

• 36 percent cited the credibility of the trial information found on-line

• 88 percent would prefer receiving clinical trial info online from a doctor. And when asked where they would first go to learn more about a trial:

• 6 percent pointed to doctors

• 24 percent said search engines

• 70 percent were comfortable receiving clinical trial messages from a healthcare association rep - the example offered was the American Diabetes Association

• 53 percent were comfortable hearing from an online support group

• 36 percent cited a live online chat

• 32 percent cited a web site message board.

• Fewer than 20 percent were most comfortable receiving clinical trial messages by way of a Facebook wall or a Twitter profile. Meanwhile,

• Only 30 percent were aware of key clinical trial websites, with

• Only 18 percent were specifically alert to ClinicalTrials.gov.

“The reality is that, in many cases,

patient recruitment via social media

will be an uphill battle,” says

Gossen.“But all is not lost. You can still

recruit patients who frequent social

media sites with advertising on those

sites, thereby eliminating the

challenges of patient recruitment on

social media websites.”

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