Vol.2, No.7, 742-752 (2010)
Copyright © 2010 SciRes. Openly accessible at http://www.scirp.org/journal/HEALTH/
Barriers and facilitators to mexican-american
participation in clinical trials: physician and
patient focus group perspectives
Jesse Nodora1, Tomas Nuño2, Ken O’Day3, Virginia Yrun2, Francisco Garcia2*
1National Center of Excellence in Women’s Health and the Arizona Cancer Center, University of Arizona, Tucson, USA
2National Center of Excellence in Women’s Health and the Mel and Enid Zuckerman College of Public Health, University of Arizona,
Tucson, USA; *Corresponding Author: fcisco@u.arizona.edu
3Xcenda, Palm Harbor, USA
Received 16 March 2010; revised 21 April 2010; accepted 22 April 2010.
Racial/ethnic minority populations are under-
represented in clinical trials and Hispanic par-
ticipation rates are particularly low. This study
assessed barriers and facilitators to clinical tri-
als participation by Medicaid eligible Mexican-
Americans and their serving physicians. Quali-
tative data from two focus groups conducted
among Mexican-American Medicaid eligible pa-
tients and four physician focus groups were
analyzed. Mexican-American patients have a
basic understanding of clinical trials. While m o st
are open to p articip ating in clinical research, not
speaking English, time, and transportation were
identified as barriers. Physicians believe that
desperation and financial need are the primary
patient motivators for participation. Barriers to
physician recruitment and referral include: lack
of information about clinical trials, concern that
study participation may not be in the patient’s
best interest, and lack of staffing and time to
conduct trials. Ample opportunities exist to en-
gage providers and patients in future efforts to
increase Mexican-American patient recruitment
into clinical trials.
Keywords: Clinical Trials Participation;
Mexican-American; Hispanic; Medicaid Patients;
Medicaid Physicians; Foc us Groups;
Qualitative Methods
In a poll of clinical investigators conducted by Applied
Clinical Trials, 56% of respondents identified participant
recruitment as the most pressing issue in the conduct of
clinical trials [1]. Difficulty in recruiting participants
increases the time it takes to complete clinical trials,
delays approval of new medications, and reduces incen-
tives for drug development. Recruitment appears to be
particularly challenging among racial/ethnic minority
populations, and these groups tend to be seriously un-
derrepresented in clinical trials [2]. Under representation
of minority populations in clinical trials limits our un-
derstanding of the wide range of biological, social, and
cultural factors that influence treatment response and
reduces the generalizability of new treatments to minor-
ity groups; it thus may contribute to health disparities [3,
4]. Also, as a matter of equity, those suffering from dis-
ease should have access to new and promising treat-
ments through clinical trials, regardless of their racial
and ethnic identities.
As part of the National Institutes of Health Revitaliza-
tion Act of 1993, the United States Congress mandated
that women and minorities be included in clinical trials
in a manner “sufficient to elicit information about indi-
viduals of both sexes/genders and diverse racial and eth-
nic groups” [5]. Despite this mandate, recent studies
continue to show disproportionately low participation
levels by minorities in clinical trials [6-9], and participa-
tion by Hispanics is especially low. For example, a study
of US National Cancer Institute (NCI) sponsored clinical
trials found that Hispanics were the most under repre-
sented racial/ethnic group [8]. Research into the factors
responsible for under representation of minorities in
clinical trials has largely focused on African-Americans,
and comparatively little of this research has explored
barriers among other ethnic racial/minority groups [6].
The process of recruiting patients to clinical trials in-
volves both patients and the clinical investigators (or
their representatives) who are responsible for presenting
J. Nodora et al. / HEALTH 2 (2010) 742- 752
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the trial for consideration by patients. Two recent reports
on clinical trials recruitment among racial/ethnic minori-
ties recommended more research to explore factors and
mechanisms influencing patient-provider roles, especial-
lly those related to clinical trials communication [10,11].
Both reports suggested that clinical trials education is
most likely to reach minority populations by providing
tailored information to non-specialists primary health
care providers in a community setting.
The term Hispanic includes individuals identified by
the Office of Management and Budget Directive 15 as
“A person of Mexican, Puerto Rican, Cuban, Central or
South American, or other Spanish culture or origin, re-
gardless of race” [12]. By 2050 it is estimated that one
out of every four Americans will be of Hispanic ethnic-
ity [13]. Persons of Mexican descent account for over
60% of all US Hispanics (the next closest group, Puerto
Ricans, account for less than 10% of all US Hispanics)
[14]. Also, Mexicans represent 32% of all US immi-
grants, the next closest group (Filipinos) are at 5% [15].
Although Hispanics share a common language, there are
many cultural differences among the various sub-groups.
In the present report, we focus on Mexican- Americans,
the largest group of Hispanics in the US, and present the
results of a series of focus groups designed to explore
perceived barriers and facilitators to clinical trial partici-
pation among both Mexican-American patients and the
physicians who care for them.
We conducted focus groups with Mexican-American
Medicaid eligible patients and their serving physicians to
learn about barriers and facilitators to clinical trial par-
ticipation. Structured open-ended interview-guided pa-
tient focus groups explored issues around patient bar-
riers and facilitators to participating in clinical trials.
Using the same technique, physician focus groups ex-
plored issues around patient barriers and facilitators and
physician barriers and facilitators to recruitment and
referral of patients to clinical trials. A total of six focus
groups were conducted between May and August 2006.
Two focus groups were conducted with patients, two
with physicians that do not recruit or refer patients to
clinical trials, and two with physicians that do recruit or
refer patients to clinical trials. The study was reviewed
and approved by the Institutional Review Board at the
University of Arizona.
The study participants for the patient focus groups
were Mexican-American Medicaid eligible patients. All
were residents of Maricopa County in central Arizona.
Patients were recruited by telephone from a comer-
cially available list of Hispanic households. Patients
were queried using a series of screening questions (Ta-
ble 1) and were invited to participate if they: 1) made
health care decisions for themselves or their family; 2)
had interacted with the health care system within the
past 18 months; 3) were between the ages of 30 and 65;
and, 4) were Medicaid eligible (i.e., had a household
income of less than 100% of the Federal poverty level).
The study participants for the physician focus groups
were community primary care physicians who serve
Medicaid patients. Physicians were recruited by tele-
phone using a list of Medicaid eligible providers and
were queried about whether they recruit or refer patients
to clinical trials. Physicians that recruited or referred
patients to clinical trials and those that did not recruit or
refer patients were invited to participate in separately
scheduled focus groups.
Trained interviewers conducted each focus group us-
ing a structured interview guide. The interview guide
was developed and revised through an iterative process
involving the above noted literature review of barriers
and facilitators to patient participation in clinical trials.
In addition, members of the research team conducted an
expert review, and a sample of Mexican-American wo-
men visiting the Women’s Health & Resource Center
performed a community member review. Questions on
the interview guide were open-ended and aimed to elicit
participants’ thoughts and feelings on various issues re-
lating to clinical trials, recruitment, and participation.
Patient interview guides also included questions about
patients’ awareness and attitudes about clinical trials,
participation in clinical trials, barriers and facilitators to
participation, and the role of culture and ethnicity. Phy-
sician interview guides included questions about patient
barriers and facilitators, patient characteristics that affect
patient willingness to participate, physician experiences
in recruiting or referring patients, and physician barriers
and facilitators to recruiting or referring patients.
The patient focus groups were conducted in Spanish
and the physician focus groups were conducted in Eng-
lish. Focus groups ranged in size from 5 to 9 participants
and each session lasted between 90 and 120 minutes. All
focus groups took place in a focus group interviewing
room with integrated audio recording equipment. All
focus groups were audiotaped. Patient focus groups
conducted in Spanish were subsequently translated and
transcribed into English. Physician focus groups were
transcribed verbatim in English.
Two members of the research team read and re-
viewed the transcribed focus group interviews for
themes and codes in a two-part process. First, a concept-
tual model of factors affecting patient participation in
clinical trials, based on a model developed for AHRQ,
was revised and used to develop a set of themes and
J. Nodora et al. / HEALTH 2 (2010) 742- 752
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Table 1. Patient and physician focus group questions.
Patient Questions (Spanish)
Healthcare system (El Sistema de Salud)
1. Do you have a regular doctor that you see? In choosing your doctor what’s important to you? (¿Tiene un doctor que visita con
regularidad? En elegir a su doctor, ¿que es importante para usted?)
2. As a Hispanic, how important is it for you to have a doctor who is Hispanic or who understands your langua ge and culture? (¿Como
Latino/a, que importancia tiene para usted tener un médico que es Latino o que entienda su idioma y cultura?)
Attitudes about Research and Clinical Trials (Actitudes Sobre las Investigaciones y los Ensayos Clínicos)
1. What do you think about medical research? (¿Qué piensan sobre las investigaciones médicas?)
2. Who benefits from medical research? (¿Quién beneficia de las investigaciones médicas?)
Participation in Research and Clinical Trials (Participación en las Investigaciones y los Ensayos Clínicos)
1. Has anyone ever been aske d to participate in a clinical trial or had a family member who was asked to participate in a clinical t rial?
(¿Alguien de ustedes ha sido invitado a participar en un ensayo clínico o han invitado algún miembro de su familia a participar en un
ensayo clínico?)
2. Now, even for those of you who haven’t ever been asked to participate, I’d like you to imagin e a s i t u a t i o n w h e re you visit your doctor
for some health problem and toward the end of your visit your doct or me nt ion s th at yo u m ig ht be eligible to participate in a clinical
trial. How would you feel about participating? (Ahora, para los que nunca han sido invitados a participar, imagínense una situación
donde visitas a su médico y al final de su visita su médico menciona que quizás sea candidato para participar en un ensayo clínico.
¿Cómo se sentiría acerca de participar?)
Barriers and Facilitators (Barreras y Promotores)
Let’s talk about some specific reasons that would influence you or someone in your family when making a decision about whether to participate
in a clinical trial (Hablemos acerca de algunas de las razones que podrían influir su decisión, o la decisión de un familiar, para participar en un
ensayo clínico)
1. What are some of the reasons you might decide to participate? (¿Cuáles son algunas de las razones para participar?)
2. What are some of the reasons you might decide NOT to participate? (¿Cuáles son algunas de las razones por cual NO participará?)
Culture and Ethnicity (Cultura y Origen Étnico)
1. Do cultural and language issues influence your decision to participate in a c li n ic a l t ri a l? (¿La cultura y el idioma influyen su
decisión para participar en un ensayo clínico?)
2. Would being approached by a doctor who is Hispanic or who understands your language and culture influence your decision to par-
ticipate? (¿Influyera su decisión para participar siendo invitado por un médico Hispano o de habla Hispana que entienda su cultura?)
3. Do you think physicians are more or less likely to ask Hispanic patients to participate in clinic a l tri al s? (¿Piensa que es más, o
menos, probable que los médicos piden a Hispanos que participen en ensayos clínicos?)
Physician Questions
Physicians Thoughts on Patients and Clinical Trials Participation
1. How aware would you say your typical patient is of clinical trials? Do they know what t hey are for?
2. Do you think the exis tence of clinical trials is well communicated (to patie nt s) in general?
3. When patients bring up the subject of clinic al tri als do they have any preconceptions?
4. What are your thoughts on your (Medicaid) patient’s [knowledge, interest, and barriers/facilitators] related to clinical trials partici-
5. How does Hispanic culture influence clinical trials participation for Medicaid patients ?
6. How can physicians increase clinical trial s p articipation among their Hispanic Medic aid pa tients?
Physician Facilitators and Barriers to Clinical Trials Participation
1. Have you referred patients to cli n i c a l trials? Was this a p os it iv e or n eg a ti ve experience?
2. What is your interest in increasing your involvement in clinica l research activities?
3. What would facilit a t e achievement of your desired research activity level (issues and solutions for physicians involved in research
versus those not involved in research)?
J. Nodora et al. / HEALTH 2 (2010) 742- 752
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codes [6]. Transcripts were independently reviewed by
two researchers, and passages were thematically classi-
fied as they related to the following patient and physic-
cian themes: awareness, attitudes, resources, and oppor-
tunities. The researchers then met to review these classi-
fications and resolve disagreements. The result of this
systematic review process was a set of passages from
each transcript for each theme-code pair.
A summary of patient and provider focus group out-
comes are shown in Table 2 and more detailed results
are presented in the following sections. Please note that
the qualitative nature of focus group results does not
easily allow for exact quantification of responses. As a
general reference, when we state that “some,” “many,”
or “most” participants provided a given response the
approximate percentages are 40, 70 and 90 percent, re-
3.1. Patient Focus Groups
The two patient focus groups included a total of 13 Me-
xican-Americans who met eligibility criteria for Medi-
caid services. Most participants (77%) were women, and
the mean age was 39 years.
3.1.1. Patient Awareness
Patients expressed a basic understanding that clinical
trials involve research to determine whether medications
and treatments are safe and effective. However, some
patients believe that clinical trials involve practice by
inexperienced physicians. None of the patients in our
focus group sample had participated in a clinical trial,
but some reported that friends or family members had
3.1.2. Patient Attitudes
Most patients believe that clinical trials are good and
help to advance science. The most commonly expressed
reasons for not participating in clinical trials included:
fear of adverse events, lack of trust in the physician, and
being part of an experiment in which inexperienced phy-
sicians/health care providers are involved. A commonly
expressed reason for considering participation was the
development of more effective medications that would
benefit the participant and others. Many patients ex-
pressed that they would like more information about
clinical trials before making a decision about whether to
participate. Most patients indicated that they would
consult their family members to help them decide wh-
ether to participate. Also, most of the patients in the fo-
cus group indicated that they would be willing to par-
ticipate and indicated that trust in their physician would
be a significant factor in their decision.
3.1.3. Patient Resources
Time constraints and transportation pose barriers for
some patients. For patients who lack access to health
care or medications, obtaining access to care or medica-
tions through a clinical trial would be an incentive to
participate. Many patients indicate that they would like
better information to help them understand what clinical
trials are about and they believe that television would be
the best medium to inform and educate Mexican-
American communities.
3.1.4. Patient Opportunities
Patients believe that being Spanish speaking (not speak-
ing English) poses a significant barrier to participation
and that translators are often inadequate or unavailable.
Patients believe that as Mexican-Americans, they are
less likely to be asked to participate in clinical trials,
primarily due to the language barrier.
3.2. Physician Focus Groups
The four physician focus groups included a total of 26
doctors, of whom 6 (23%) were women and 4 (15%)
were Hispanic. Their clinical practice specialties were 14
(54%) in family medicine, 6 (23%) in internal medicine,
and 6 (23%) in other types of medical practice.
3.2.1. Physician Perception of Patient
A wareness
Physicians think that patients have little awareness or
understanding of clinical trials. Physicians have differing
views regarding how a patient’s level of education af-
fects their understanding: some believe that Medicaid
patients have more difficulty understanding what clinical
trials are, while others think Medicaid patients are no
different from other patients. Non-recruiting physicians
indicate that patients sometimes bring up clinical trials
seeking physician reassurance or approval before par-
ticipating. Some non-recruiting physicians believe that
patients tend to overestimate the likelihood of side ef-
fects from study medications.
3.2.2. Physician Perception of Patient Attitudes
Physicians believe that patients with severe disease and
those who are in financial need are more inclined to par-
ticipate in clinical trials. Physicians believe that their
relationship with patients can be very influential upon
patient attitudes toward participating in clinical trials.
Some recruiting physicians indicate that patient fear of
side effects is a barrier. Many non-recruiting physicians
indicated that Mexican-American patients are private
and may take some time to develop trust, but once trust
is established they are very trusting of their physicians.
J. Nodora et al. / HEALTH 2 (2010) 742- 752
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Table 2. Focus group patient and physician outcomes.
Facilitators Barriers
Want to participate in clinical trials Believe clinical trials are done by inexperienced physicians
Will ask physicians about clinical trials Fear adverse effects and experimentation
With physician’s trust will participate in clinical trials Lack of trust in the physician
Believe clinical trials help advance science Time constraints
Believe clinical trials help develop better drugs Lack of transportation
Have basic understanding of clinical trials as research Being Mexican-American (language & culture)
Use television to recruit Mexican-Americans Speaking only Spanish
Facilitators Barriers
Want more information on clinical trials Get little information on clinical trials
When clinical trials provide physician assistance and needed resources Do not know where to go for information on clinical trials
Community physicians can be effective in recruitment Believe patients are likely to overestimate side effects
Electronic medical records Believe patients know little about clinical trials
Clinical trial medications and procedures Loss of patients to clinical trials
Continued access to medication(s) after clinical trial ends
Fear of being perceived as “on the take” by patients
Lack of staffing and time
Difficult to follow up some Mex. Am. Patients
Some recruiting physicians believe that Mexican-Ame-
rican patients are more difficult to recruit, but other re-
cruiting physicians indicate that Mexican-American pa-
tients are no different from other patients in terms of
their receptiveness to participation.
3.2.3. Physician Perception of Patient
Economic hardship was thought to be an incentive for
some patients to participate, but that it also makes clini-
cal trials a low priority for patients who are experiencing
economic hardship. Most physicians believed that trans-
portation and distance are barriers for many patients, and
that the impact of clinical trial participation on patient’s
employment may be potentially detrimental. Some re-
cruiting physicians believe data collection burdens are a
barrier to patient participation.
3.2.4. Physician Perception of Patient
Some recruiting physicians stressed that there is consid-
erable cultural variety among Mexican-American patients.
Some physicians believe that their patient population’s
limited interaction with the health care system and the
difficulty their offices encounter in contacting and fol-
lowing up with patients may limit opportunities for par-
ticipation. Some thought that better advertising and get-
ting interested community physicians involved in re-
cruitment might also help improve patient opportuni-
3.2.5. Physician Awareness
Most physicians indicate that they get very little infor-
mation about clinical trials and would like additional
information about studies. Many physicians say that they
do not know where to obtain information about clinical
trials and are only aware of trials that they see ads for in
the newspaper or hear about on the radio.
3.2.6. Physician Attitudes
Many physicians express concern about whether their
patients would continue to have access to the study
medication after the study is over. Some physicians are
concerned about how they will be perceived by their
patients if they recruit or refer them to clinical trials. A
few of these physicians expressed ethical concerns about
conflict of interest and that patients would perceive them
as being “on the take,” (i.e., receiving inappropriate co-
J. Nodora et al. / HEALTH 2 (2010) 742- 752
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mpensation for putting patients on a given study) par-
ticularly in the case of “skeptical minority” patients.
Some physicians expressed general concern that partici-
pation in clinical trials may not be in their patient’s best
interest. Others voiced a specific concern that patients
will be assigned a placebo intervention and that this
might adversely impact their treatment plan. Some phy-
sicians are worried that referring or recruiting patients to
clinical trials could potentially raise liability issues, or
may lead to the eventual loss of the patient after the
study is completed. Recruiting physicians believe that
altruism is a limited patient motivation for participating.
Physicians are more favorably disposed toward studies
involving important new medications and less favorable
toward studies involving “me too” drugs (i.e., slight
modification of an existing drug). Some physicians pre-
fer to leave the subject of clinical trials participation for
the patient to initiate and will only discuss the subject if
the patient brings it up. Some non-recruiting physicians
were quite favorably inclined toward clinical trials, while
others are very skeptical. Some recruiting physicians
said that they were motivated to recruit or refer patients
in order to help them.
3.2.7. Physician Resources
Lack of staffing was identified by many physicians as a
barrier to conducting recruitment and referral activities.
Some of these physicians indicated that a research study
coordinator would be necessary to conduct recruitment
and referral activities in their office. Physician time con-
straints also limit the ability to recruit or refer patients.
Some physicians were concerned that referring patients
to clinical trials might result in a loss of patients for their
practice, and a negative economic impact. Most physic-
cians indicated that assistance (e.g., administrative coor-
dination, provider and patient materials) would be nec-
essary for them to recruit or refer patients to clinical trials.
3.2.8. Physician Opportunities
Some recruiting physicians say that they do not receive
much information about trials and have had to take the
initiative to identify study opportunities for patient re-
cruitment and referral. For many this represents an inor-
dinate burden for routine referral of patients to clinical
trials. Some recruiting physicians believe that electronic
medical records have made it easier for them to partici-
pate in referring or recruiting patients by improving their
ability to identify eligible patients and more easily tran-
sfer information.
Without presenting the many research-related social (e.g.,
culture, racism) and demographic (e.g., race, ethnicity)
complexities among such a large and heterogeneous
group [4], it is clear that compared to non-Hispanic
whites, US Hispanics are less educated, and more im-
poverished [16], and also face significant challenges in
health care access, information, and knowledge [17].
This demographic and healthcare profile, coupled with
the disproportionately low clinical trials participation
rate, increases the urgency of understanding and address-
ing the barriers to Hispanic participation in clinical trials,
especially among those of Mexican descent, which com-
prises the largest sub-group [14].
The results of our study on barriers and facilitators to
Mexican-American clinical trials participation corrobo-
rate the findings of previous research; including many of
those outlined in the recent Ford, et al. systematic review
[2]. Our conceptual model, shown in Figure 1, is adap-
ted from the Ford, et al. conceptual framework (Figure
8, p. 239) Our model integrates the key barriers and fa-
cilitators within each of four domains (awareness, atti-
tude, resources, and opportunities) selected for this study.
As depicted in Figure 1, we propose that the opportunity
to participate in a clinical trial (for both patients and
providers) must be present, and that the decision to ac-
cept or refuse is influenced by the facilitators and barri-
ers in each of the four domains. The Ford, et al., model
and our conceptual model share the Awareness and Op-
portunities domains. Based on our experience, and the
iterative process described in the Methods, we chose to
add the Attitude and Resources domains. These two do-
mains provide an important link between awareness (i.e.,
of clinical trial and what it offers) and action (ac-
cept/refuse to participate). In addition, the Resources
domain captures many of the critical facilitators and bar-
riers relevant to both patients and providers.
Our findings provide a concurrent perspective on
clinical trials participation from both Medicaid eligible
patients and the physicians who serve them. The impre-
ssion from our study participants is generally favorable
towards clinical trials research. Nevertheless, we found
important facilitators and barriers among both patients
and physicians (See Table 2 an d Figure 1).
Both patients and clinicians are interested in clinical
trials. Both express the practical barriers of time and
need for assistance. The most complex, and often most
difficult to overcome barriers for our participants revolve
around not being fluent in English; where providers (and
their staff) are not fluent in Spanish. While patients face
fears of adverse effects and “experimentation,” physic-
ians face fears of being perceived as having a conflict of
interest for referring patients to clinical trials and their
patients not having access to medications once off study.
Fortunately, many of the facilitators and barriers provide
tangible opportunity for intervention.
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Symbols: (+) indicates facilitator. (–) indicates barrier.
Description: Faced with the opportunity to participate in a clinical trial, consideration of facilitators (+) and barriers (–) within the
four domains (awareness, attitude, resources, opportunities) will influence patient and provider acceptance or refusal to participate.
Figure 1. Focus group results applied to proposed conceptual model.
Most patients indicated that they were open to the idea
of participating in clinical trials and believe that results
of these help to advance science and medicine. This is
consistent with recent findings from Markman et al. [18]
and Wendler et al. [19] who found that both Hispanics,
and African Americans, are as interested, or more inter-
ested, in learning about clinical trials as Caucasians. Ef-
forts to educate and inform Mexican-Americans and
other Hispanic patients about clinical trials should build
upon this support and beliefs by clearly explaining the
role of clinical trials in the development of new treat-
ments that are safe and effective and emphasizing that
the strict treatment protocols in clinical trials serve to
ensure the provision of high quality care. Given that
Mexican-American patients indicate that they would like
additional information about clinical trials and believe
television would be the best medium to reach them, de-
velopment of appropriate television-based clinical trials
messages may help to educate and recruit Hispanic pa-
There was near universal agreement among the patient
focus group participants that language and culture pose
significant barriers to participation in clinical trials for
Mexican-Americans. There was also near universal ag-
reement that fluency in Spanish is more important than
the ethnicity of their physician. Most patients were, in
fact, indifferent to the ethnicity of the physician. Some
patients perceive Mexican-Americans as less likely to be
asked to participate due to language barriers rather than
discrimination. Such barriers may be reduced by pro-
viding physicians who serve Hispanic patients, as well
as Spanish speaking study recruiters, with education and
outreach on appropriate Spanish language information
about clinical trials. Ramirez et al., suggest not only
outreach and education to address patient-provider lan-
guage issues, but effective use of bilingual study teams
[10]. Addressing language and culture may have the ad-
ded benefit of facilitating family communication, under-
Openly accessible at
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standing, and approval of clinical trials, which was iden-
tified as an important factor in patient decision making.
Of particular concern in our findings is that some of
the participants believed that clinical trials involve ex-
perimentation, “practice” by inexperienced physicians,
and frequent adverse events (i.e., side effects). These
findings are similar to those in a recent nationally repre-
sentative 1000 person telephone survey, which found
that African Americans and Hispanics are more likely
than whites to associate clinical trials participation with
more discomfort, pain, and side effects and to believe
that they are better off with the standard treatment [9].
This is partially related to recent research on barriers to
the recruitment of African Americans to clinical trials
[20-24]. This literature presents the significant feelings
of mistrust experienced by African Americans toward
medical researchers due to a long documented history of
research abuses in this population. While our study par-
ticipants (both patients and providers) did not voice mis-
trust specific to historical reasons related to research
abuse, physician trust was identified as an important
factor for clinical trials participation. There are likely
many complexities related to how a trusting relationship
is achieved, not least among them, the ability to commu-
nicate (language), and cultural respect. This complexity
creates many challenges to within and across group (Af-
rican American-Hispanic) generalization, particularly in
quantitative studies, and suggests the need to account for
key associations (e.g., stratify by racial/ethnic origin,
language, nativity, etc.) [25].
Limited patient resources—including time, transporta-
tion, and finances—appear to pose significant barriers to
Mexican-American participation in clinical trials. This is
not unexpected given that the patient focus group par-
ticipants for this study were all under the Federal pov-
erty level. While similar barriers may apply to low in-
come non-Hispanic patients, any efforts to address the
under representation of Mexican-Americans and other
Hispanics in clinical trials will need to address these
barriers due to the fact that these patients are dispropor-
tionately represented among low income and uninsured
populations [26].
With concurrent patient and physician data lacking,
results of the present study add an important dimension
to the study of facilitators and barriers to clinical trials
participation. Physician focus group participants, in the
two non-referring/non-recruiting groups and the two
referring/recruiting groups, were in general agreement
on many topics and raised similar themes. The similari-
ties appeared to be greater when physicians were dis-
cussing issues related to patient awareness, attitudes,
resources, and opportunities. The larger differences be-
tween the non-referring/non-recruiting groups and the
referring/recruiting groups tended to involve physician
awareness, attitudes, resources, and opportunities.
Both physicians that do not recruit or refer and those
that do, indicate that they get little information about
clinical trials. This is particularly interesting in the case
of those physicians who do recruit or refer patients.
Generally, these physicians indicate that it is up to them
to take the initiative to identify clinical trials. The fact
that willing physicians are having to go out of their way
to refer patients suggests that there are opportunities and
a need for better forms of communication between re-
searchers who are recruiting patients for clinical trials
and community physicians. Physicians indicate that they
would like more information about active clinical trials.
Physicians that do not refer/recruit, stated concerns
about patients being placed on a placebo (rather than the
study drug), the lack of patient access to the study drug
after the study concludes, and that participation in a par-
ticular study may not be in a patient’s best interest (e.g.,
of no direct health benefit). These physicians also ex-
press ethical concerns such as appearing to have a finan-
cial incentive or “bounty” for referring or recruiting pa-
tients. They were particularly sensitive about the ap-
pearance of exploiting minority patients. These kinds of
concerns may help to explain why these physicians do
not refer or recruit patients to clinical trials, especially
commercially funded trials that may provide financial
compensation for participant accrual. As suggested by
Kim et al., physicians, researchers and their institutions
need to inform patients about financial conflicts in the
same way they inform them about human subjects con-
cerns [27].
Both groups of physicians were insistent that resource
limitations adversely affect their ability to refer or recruit
patients to clinical trials. Resources to enhance staffing
(e.g., hiring a study coordinator) were thought to be es-
sential to recruiting patients. Fear of losing patients was
thought to be more of a concern for specialists who were
referring patients to trials by other specialists, than re-
ferrals by primary care providers. Efforts to increase the
proportion of community physicians who refer or recruit
patients to clinical trials will need to provide physicians
with additional resources and/or develop methods to
enhance office and staff capabilities to refer or recruit
patients. As expressed by participating physicians and
Embi et al., clinical practice tools such as electronic
medical record systems may be useful in addressing
these concerns [28,29].
Limitations of our work include small samples of pa-
tients and physicians that may not be representative of
their respective populations. In our patient focus groups,
for example, the majority of participants were women. A
different group of participants may result in different
J. Nodora et al. / HEALTH 2 (2010) 742- 752
Copyright © 2010 SciRes. Openly accessible at http://www.scirp.org/journal/HEALTH/
issues being raised. Additionally, focus group research
does not involve independent observations as partici-
pants influence one another within the context of the
focus group. While this is an advantage of focus group
research for exploring qualitative issues, it limits the
generalizability of study findings. Also, analysis of focus
group data involves a qualitative analysis of themes and,
therefore, necessarily involves a subjective element de-
spite attempts to be systematic and to eliminate bias (e.g.,
by using multiple coders). Strengths of our study pertain
to the inclusion of both patient and physician provider
focus groups in order to examine barriers and facilitators
side-by-side. In addition, the Spanish language patient
focus group protocols and questions were developed and
implemented by trained and experienced bilingual and
bicultural (Mexican-American) investigators and staff.
This helps ensure linguistic and cultural accuracy of the
study, as well as increased comfort and understanding,
which in turn affects participant trust.
Recent forecasts predict that demand for clinical trials
participants will outstrip supply [30]. Improving the re-
cruitment of minority populations is critical to address-
ing the forecast shortage of clinical trials participants as
well as ensuring the equitable distribution of the benefits
and burdens of medical research. Currently only 11% of
Arizona Medicaid (AHCCCS) primary care providers
report that they recruit or refer patients to clinical trials
(Appendix). With so few Medicaid serving physicians
recruiting or referring patients to clinical trials, there are
opportunities to engage more community physicians in
recruitment and referral activities. Initiatives such as
EDICT (Eliminating Disparities in Clinical Trials) con-
ducted by the Baylor College of Medicine and the Inter-
cultural Cancer Council (http://www.bcm.edu/edict/home.
html), as well as those conducted by the Education Net-
work to Advance Clinical Trials (ENACCT http://www.
enacct.org/) provide ready-made resources for research-
ers, health care providers, an most importantly, patients
and community leaders. As suggested by Robinson and
Trochim [31], interventions that address community and
researcher interests equally can help increase clinical
trials participation among Hispanics and other underrep-
resented populations.
Although Mexican-American Medicaid eligible patients
and the providers who serve them identify a variety of
barriers to participation in clinical trials, facilitators for
both groups validate the importance placed on clinical
research and their willingness to participate. Interven-
tions that provide clear, culturally relevant (i.e., Mexi-
can-American; primary providers serving Medicaid pa-
tients) clinical trials information, that addresses basic
barriers such as time constraints, patient-provider com-
munication and trust, are likely to increase accrual and
This project was supported by a grant from the Arizona Biomedical
Research Commission. The authors also wish to acknowledge the
Behavioral Research Corporation which provided invaluable technical
assistance with the focus groups, and the Arizona Health Care Cost
Containment System leadership which provided assistance with the
development of the study framework.
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J. Nodora et al. / HEALTH 2 (2010) 742- 752
Copyright © 2010 SciRes. Openly accessible at http://www.scirp.org/journal/HEALTH/
AHCCCS Provider Survey
In collaboration with our research team, the state Medi-
caid Agency (Arizona Health Care Cost Containment
System-AHCCCS) agreed to include a question on its
annual provider survey about primary care provider (PCP)
participation in recruiting/referring patients to clinical
trials. The item asked PCP respondents: In the past three
(3) years have you recruited or referred clients to clinical
research trials? The target population for the AHCCCS
survey included a total of 7,656 providers, consisting of
2,633 PCPs, 2,999 specialists, 729 dentists, and 1,295
office managers. The survey was conducted by mail, web,
and telephone from November through May 2006. A
total sample of 1,764 surveys was completed, including
495 PCPs. The overall response rate was 52% and the
response rate among PCPs was 51%. The table below
summarizes the results of the PCP survey data by cross-
tabulating responses of the clinical trials item with
available data about provider characteristics (note: pro-
vider sex, race, and ethnicity data are not available from
the survey). These data begin to provide a profile of the
extent to which Medicaid physicians are involved in re-
cruiting/referring patients to clinical trials. Based on this
survey we know that only 11% of Medicaid providers
currently refer patients to research studies. The only
other statistically significant difference in participation
rates relates to practice area; physicians in Maricopa and
Pima (large metropolitan) counties are more likely to
recruit or refer patients to clinical trials than in rural
Table 1*. AHCCCS provider survey results.
# %
AHCCCS PCP Respondents 495 51%
Refer or Recruit Patients to Clinical Trials
No 405 89%
Yes 52 11%
Refer/Recruit by Provider Type
Family Practice 17 12%
General Practice 2 9%
Internal Medicine 14 11%
Pediatrician 19 12%
Refer/Recruit by Practice Area*
Maricopa/Pima 45 14%
Other Counties 7 5%
Refer/Recruit by Health Plan**
APIPA 42 12%
Care 1st 13 12%
Community Connection PHP 17 10%
Health Choice AZ 27 11%
Maricopa MC 10 13%
Mercy Care Plan 42 13%
Pima Health System 17 18%
University Family Care 8 21%
*Chi square = 6.5852, df = 1, p .01
**Since each physician can accept more than one health plan, this is
not an unduplicated count