- freely available
J. Clin. Med. 2019, 8(8), 1245; https://doi.org/10.3390/jcm8081245
2. Addressing the Problem by Increasing Minority Participation
3. Future Directions
- Online delivery of training courses and information to patients and providers. These methods are low-cost and preferred by healthcare providers and professionals, as well as patients . Training courses centered around educating patients on clinical trials can give healthcare providers and professionals an opportunity to advance their education in healthcare delivery and medical practice (e.g., Continuing Medical Education credits, Continuing Education Credits, etc.). Efforts for patient-centered education on clinical trials exist in the form of delivering engaging, evidence-based and patient-centered content. There is a strong empirical foundation for best practices in the delivery of health-related content via mobile applications and technologies. Interactive media, such as video games, simulators, eLearning, and mobile apps, can also improve patient comprehension of research study protocols and risks, patient decision-making about clinical trials, and patient engagement throughout clinical trials ;
- Culturally and linguistically appropriate patient materials for patients and providers to use. Clinical trial education programs are most effective for patients when they are culturally and linguistically appropriate, less technical, and more personalized [51,52,53,54]. For healthcare providers and professionals, culturally and linguistically appropriate patient materials help them easily inform patients about lupus clinical trials. Furthermore, the use of effective supplemental materials in patient education has been shown to increase the likelihood of providers following through with a recommended behavior (i.e., referring lupus patients to lupus clinical trials) ;
- Active dissemination methods for providers and patients. Active dissemination methods such as outreach conducted by healthcare professionals to other healthcare professionals, are more effective than passive dissemination such as mail, e-mails, or newsletters [56,57]. The same goes for patients, as patient advocates have been shown to help mitigate many of the barriers identified in Table 1 by providing peer education and support to other patients with lupus. Patient advocates are beneficial to clinical trials’ referrals, enrollment, and retention . In fact, the Institute of Medicine recently called for the greater involvement of patient advocates in the design of clinical trials and in patient recruitment efforts to encourage patient acceptance and participation in clinical trials . For healthcare providers and professionals, colleagues are often the main source of information about clinical trials . Studies find that healthcare providers and professionals who are confident in the principal investigators or site conducting a clinical trial, and who are familiar with the trial’s protocols, are much more likely to refer patients .
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|Access||Lack of access to rheumatologists who are most likely to know about lupus clinical trials |
Lack of transportation to the clinical trial site , child care , or paid leave to miss work 
Lack of health insurance and cost concerns  1
Lack of bilingual research staff or informational material about clinical trials 
|Opportunity||Lack of awareness of clinical trials |
Lack of minority providers to refer minority patients to clinical trials 
General lack of referral by providers 2
|Mistrust||A history of exploitation in research in African American communities [20,23,25]|
Fear among Latino immigrants of being deported as a result of participating in a clinical trial 
Feelings of uncertainty and anxiety about clinical trials 
Fear of a negative impact on quality of life through loss of autonomy and side effects [24,26]
Discomfort with “experiments” and feeling like a “guinea pig” [20,23]
|Health literacy||Lack of education about disease |
A dislike and misunderstanding of study group randomization 
Feelings of intimidation and misunderstanding about the informed consent process 
Belief that the clinical trial has little or no benefits [22,28]
Challenges understanding study documentation written at too high a reading level 
|Cultural||Excluding family members in enrollment and participation deters Latino patients |
Lack of a friendly patient–provider relationship 
|Awareness and knowledge||Lack of access to clinical trial information |
Lack of familiarity with clinical trial sites and principal investigators 
Lack of knowledge about the clinical trial protocol 
Disconnect between the patient’s eligibility and provider assessment of patient’s eligibility 
|Attitude/implicit bias||Beliefs that minority patients will not understand and adhere to specific protocols |
Beliefs that the clinical trial could have a negative impact on the provider–patient relationship  (if they refer their patient to a clinical trial, they will lose their patient to the clinical trial’s practice or it will have a negative effect on their interpersonal relationship )
Beliefs that the clinical trial is unsafe or coercive 
|Logistical||Lack of time to talk to patients and to learn about clinical trials |
Lack of connection with clinical trial site or principal investigator 
Lack of clinical trials in close proximity to the provider’s office 
|Provider-focused education interventions||Materials to Increase Minority Involvement in Clinical Trials (MIMICT)|
An education program for specialists (rheumatologists, nephrologists, dermatologists, and others), primary care physicians, RNs, NPs, and PAs. Developed by the American College of Rheumatology, with funding from the US Department of Health and Human Services Office of Minority Health.
|Partnership-based interventions||Community Health Worker (CHW) Lupus Clinical Trials Training (LuCTT)|
A program to develop community partnerships and train CHWs to support the recruitment and enrollment of minority people with lupus into clinical trials, developed by the American College of Rheumatology, with funding from the US Department of Health and Human Services Office of Minority Health.
|Patient-mediated interventions||Programs to address Unmet needs and promote Representation of all Participants in Lupus clinical trials using mobile technology for Engagement (PURPLE)|
A patient-focused digital tool delivering culturally and linguistically appropriate patient clinical trial education, developed by University of North Carolina Thurston Arthritis Research Center, with funding from the Fund for Excellence in Lupus and Sjogren’s.
|Peer-mediated interventions||Patient Advocates for Lupus Studies (PALS)|
Peer-to-peer education program in which individuals living with lupus who have participated in clinical research activities provide education and guidance to those living with lupus who have never participated, developed by Lupus Therapeutics in partnership with KDH Research and Communication.
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