Solving Patient Identification and Enrollment Challenges in Clinical TrialsHow a Patient-Centric Approach Combined with Novel Technology Results in More Qualified, Engaged Patients

In an effort to control escalating costs and avoid expensive study delays, clinical trial stakeholders are looking at novel approaches to attracting and retaining larger pools of qualified trial participants. In addition to implementing innovative technologies to improve the identification of potential participants, sponsors and clinicians are seeking ways to better address the needs of patients, such as making trials more accessible and convenient to larger segments of the population.

A patient-centric approach can control study costs, as well as create greater participant

diversity and make trials more readily available to certain patients who previously had limited

opportunities to participate in life-enhancing and potentially life-saving clinical trials.

What follows are several approaches that sponsors and contract research organizations

(CROs) should consider to make clinical trials more patient-centric, including involving

community physicians; making trials more accessible to more patients (including targeting

previously underrepresented patients); and making trial participation more convenient.

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Involving the doctor

Leveraging the physician-patient relationship makes for a more patient-centric and positive experience that leaves the patient

feeling that he or she is surrounded by a team of caring and motivated providers. Patients are grateful when their community

physician proactively brings trial opportunities to them and helps them through the process, since their doctor is familiar with the

patient’s disease state/s and medical history. Not surprisingly, nearly three-quarters (72 percent) of Americans say it’s likely they

would participate in a clinical trial if recommended by their doctor.1

Physician-referred patients are also more likely to remain in a trial for the duration and to be adherent with the study protocols.

Traditionally, about one-third of patients drop out of studies before completion.2 When community physicians are involved in the

process, they have the opportunity to fully review patients’ medical records in advance to determine the likelihood of meeting

study inclusion and exclusion criteria. Physician-referred patients also are more likely to remain engaged in the trial process

because they continue to see the physician for their routine healthcare needs during their clinical trial participation.

THE EPATIENTFINDER CLINICAL TRIAL EXCHANGE™ PROCESS

SUBMISSION

QUALIFICATION

CONNECTION

PUBLICATION

NOTIFICATION

THE EPATIENTFINDER MODEL: PROVIDER PARTICIPATION IS KEY

The ePatientFinder® model for clinical trial identification and

enrollment is based on the assumption that patients are

more likely to participate in clinical trials if their physicians are

involved in the process. This approach includes automated

outreach to referring physicians when relevant trials

become available in their area, or when a newly diagnosed

patient appears well-qualified for an existing trial.

Alternatively, referring physicians have the option to run a

pre-configured query of their own electronic health record

(EHR) databases to find qualified candidates.

Participating physicians provide the ePatientFinder program

with secure, compliant access to their EHR databases.

Databases are accessed regularly to identify qualified

patients and their treating providers. This visibility also

provides researchers with critical insights into how to attract

a larger percentage of qualified participants, such as

optimizing protocol designs or establishing study sites in

a specific geographic area.

Meanwhile, the ePatientFinder model compensates

physicians for their participation and pays them at a rate

comparable to what they would receive for regular patient

care. CROs and sponsors benefit from the ability to tap into

an greatly expanded population of qualified patients that

have never before participated in trials.

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Making trials accessible to all patients

A patient-centered approach helps make clinical research trials more accessible to a larger cross-section of patients. Unfortunately,

community physicians—and their patients—are typically less involved in the clinical trial process than those at large academic medical

centers because they have less visibility to active studies. This means a large segment of the population never has the opportunity

to gain early access to the advanced therapies offered in clinical trials. However, the widespread adoption of EHRs and the use of

sophisticated analytics is making it possible for physician sites to identify all potentially eligible patients. For example, because EHRs

typically contain codified fields that match various study inclusion and exclusion criteria, practices can easily pinpoint those patients

that may be protocol-eligible.

A patient-centric model can also improve the diversity of study participants. According to the Food and Drug Administration (FDA),

minority patients—along with elderly patients and women—have historically been underrepresented in clinical trials.3 African-American

patients, for example, comprise 13.2 percent of the population, but only 5 percent of clinical trial participants, while Hispanic patients

represent 16 percent of the population, but just 1 percent of participants. Meanwhile, Caucasian patients account for 67 percent of the

population and 83 percent of research participants.3

Ethnic diversity is critical in the trial process because different ethnicities respond differently to the same disease and to different

therapies. Consider the blood thinner clopidogrel, or Plavix, which FDA approved in 1997. Today we realize that about 50 percent of

Asian patients and 75 percent of Pacific Islanders lack the enzymes required to activate the drug.4

Similarly, certain classes of hypertension drugs have recently been found to be less effective in African-American patients, while

African-Americans with a certain common genetic variation require lower doses of the blood thinner warfarin compared with

Caucasian patients.5,6

Traditionally low clinical trial participation rates among minorities have been fueled by feelings of mistrust among potential participants,

as well as an overall lack of awareness of potential trials. Language barriers can also create an obstacle. Researchers who adopt a

patient-centric approach to trial enrollment—especially by working directly with the patients’ physicians—are more likely to work to

increase overall patient trial awareness, as well as address potential misgivings on the part of patients.

THE TUSKEGEE SYPHILIS STUDY

Past mistakes on the part of the government have contributed to feelings of mistrust among clinical trial potential participants, especially among the African-American community. Perhaps the most famous and well-documented example of unethical clinical research involved the U.S. Public Health Service and its Public Health Service’s Tuskegee syphilis study.7

The study induced 600 African-American men to participate in various experiments over a 40-year period. Participants who were diagnosed with syphilis were never informed of their condition, nor were they offered treatment. Many died of the disease, infected their wives, and/or passed congenital syphilis to their children.7 As a result, residual mistrust of clinical trials remains today among many members of the African-American community.

4©2017 ePatientFinder Inc. v.6.09.17.1www.ePatientFinder.com

Target groups of patients

In order to manage study costs and increase efficiencies,

researchers prefer to locate studies in areas where there

are large concentrations of potentially protocol-eligible

study participants. However, researchers have traditionally

had difficulty identifying how many patients with specific

medical conditions reside in specific areas. As organizations

seek to make studies more patient-centric and accessible to

larger numbers of potentially qualified patients, innovative

heat-mapping tools that leverage EHR data are making the

identification process easier.8

Heat-mapping helps researchers identify areas where

clusters of potentially eligible patients exist. With the

integration of powerful analytics, heat-map data can be

made actionable and individual patients identified. Study

organizers can then reach out to patients on an individual

basis to advance the trial enrollment process.

Make participation convenient

Researchers must work to ensure that trial participation is as convenient as

possible for participants. Participants are more likely to remain engaged in

the process if participation is convenient, which means organizers may need

to make accommodations to minimize certain practical burdens.

To increase accessibility, study organizations may opt to provide special

assistance when a patient has difficulty making appointments because

he or she is responsible for dependent children or has other responsibilities

that could limit participation. Researchers also may want to offer evening or

weekend appointments for participants who are unable to make appointments

during regular work hours. If transportation is an issue, study coordinators or

organizations that support them may opt to coordinate a car or medical van.

For example, ePatientFinder works with a company, Circulation, that arranges

transportation via Uber for patients who need transportation to trial sites

during the identification and enrollment process.

+

Learn about the GeoPrecise partnership with AllScripts >

5©2017 ePatientFinder Inc. v.6.09.17.1www.ePatientFinder.com

Patients who learn about a clinical trial from their doctors are more likely

to participate. In fact, nearly three-quarters (72 percent) of Americans say it’s likely they would participate in a clinical trial if recommended by

their doctor.1

Referred patients are thoroughly pre-screened, and as a result, are far more likely to be accepted into a trial. In fact, in a recent chronic conditions trial, 78 percent of patients referred

by ePatientFinder were accepted for study participation, compared to 3 percent of patients referred by traditional, direct-to-patient

recruitment methods.9

Patients are more likely to remain in a trial for the duration and to be adherent with the study protocols.

Traditionally, about one-third of patients drop out of studies before

completion.2 With the ePatientFinder model, patients continue to see their

referring physician for routine medical care, which adds another layer of accountability and engagement.

KEY BENEFITS OF THE EPATIENTFINDER APPROACH OVER TRADITIONAL PATIENT RECRUITMENT METHODS:

72%

78%3%

1/3

EPATIENTFINDER®: OFFERING A NEW APPROACH TO PATIENT RECRUITMENT ePatientFinder®’s approach to identifying and enrolling clinical trial participants is patient-centric and involves working directly with the doctors who are treating protocol-eligible patients. Using the innovative Clinical Trial Exchange™ platform, physicians are able to easily identify, thoroughly screen, and refer patients to clinical trials in their community.10

The Clinical Trial Exchange connects life-science companies—including numerous “top 10” pharmaceutical, medical device and CRO clients— with a robust network of referring physicians. The exchange is deployed through numerous top-tier EHR and health IT partnerships that provide access to more than 100 million patient lives across the United States.

Contact sales@epatientfinder.com for more information.

Embracing change

In order to minimize trial costs and avoid study delays, clinical trial stakeholders must consider new approaches for identifying

and enrolling qualified trial participants. By leveraging new technologies, study sponsors can improve the identification of

potential participants, as well as make trials more accessible and convenient to a larger segment of the population. Making trials

more readily available to previously underrepresented patient populations also leads to greater participant diversity.

One novel, patient-centric approach to consider includes working directly with the community physicians who treat protocol-

eligible patients. Referring physicians and trial sponsors/CROs can be connected via EHRs and other health IT partnerships,

providing access to millions of patient lives. This method also reduces study costs and minimizes delays because physician-

referred patients are typically better qualified than self-referred patients and remain more engaged in the trial process.

6www.ePatientFinder.com ©2017 ePatientFinder Inc. v.6.09.17.1

ePatientFinder is a revolutionary way for physicians to connect their patients to life-changing treatment opportunities — and increase revenue. Our innovative platform notifies you when new treatments relevant to your patients become available in your area. Powerful analytics technology and an innovative three-tier filtering process enable you to quickly and easily identify which patients could benefit from the treatments you choose to offer.

3801 S. Capital of Texas Hwy Suite 320 Austin, TX 78704T: (877) 373-7372D: (512) 308-6378www.epatientfinder.com

©2017 ePatientFinder Inc. v.6.09.17.1

Sources1. Poll: Majority of Americans would participate in clinical trials if recommended by doctor. Elsevier website. Available at:

https://www.elsevier.com/connect/poll-majority-of-americans-would-participate-in-clinical-trials-if-recommended-by-

doctor. Accessed April 26, 2017.

2. Tointon A. The issue of patient retention in clinical trials. CenterWatch NewsOnline. June 27, 2016. Available at: http://

www.centerwatch.com/news-online/2016/06/27/issue-patient-retention-clinical-trials/. Accessed April 26, 2017.

3. Bookbinder M. The diversity problem: Making clinical trials work for everyone. Clinical Informatics News. March 31,

2016. Available at: http://www.clinicalinformaticsnews.com/2016/3/31/diversity-problem-making-clinical-trials-work-

everyone.aspx. Accessed April 26, 2017.

4. Dean L. Esomeprazole therapy and CYP2C19 genotype. In: Medical Genetics Summaries [Internet]. October 1, 2012

[updated March 8, 2016]. Available at: https://www.ncbi.nlm.nih.gov/books/NBK100896/. Accessed April 26, 2017.

5. Feller S. Widely used hypertension drugs less effective in black patients. UPI website. September 15, 2015. Available

at: http://www.upi.com/Health_News/2015/09/15/Widely-used-hypertension-drugs-less-effective-in-black-

patients/2411442343540/. Accessed April 26, 2017.

6. Blacks with certain gene need lower doses of warfarin: Study. U.S. News & World Report. June 5, 2013. Available at:

http://health.usnews.com/health-news/news/articles/2013/06/05/blacks-with-certain-gene-need-lower-doses-of-

warfarin-study. Accessed April 26, 2017.

7. About the USPHS Syphilis Study. Tuskegee University website. Available at: http://www.tuskegee.edu/about_us/

centers_of_excellence/bioethics_center/about_the_usphs_syphilis_study.aspx. Accessed April 26, 2017.

8. ePatientFinder and Allscripts launch GeoPrecise™ solution, a game-changing heatmap tool for clinical trial site selection

and patient identification [press release]. ePatientFinder website. January 10, 2017. Available at: https://epatientfinder.

com/epatientfinder-allscripts-launch-geoprecise-solution-game-changing-heatmap-tool-clinical-trial-site-selection-

patient-identification/. Accessed April 26, 2017.

9. ePatientFinder Data on File. Current as of May 1, 2017.

10. About us page. ePatientFinder website. Available at: http://www.epatientfinder.com/about/. Accessed April 26, 2017.