Strategies to Engage Underrepresented Populations Improves Inclusivity in Clinical Trials

Marvella E. Ford, PhD

Strategies for more racial and ethnic minority inclusion in clinical trials, including community engagement practices, have been identified by a group of investigators in an effort to increase enrollment of underrepresented populations. Implementation of these approaches may ensure that racial and ethnic populations have access to more personalized medicine, according to a study published in the Journal of Oncology Practice.¹

Patients with cancer enrolled in clinical trials account for <10% of the overall population with cancer in the United States, and racial and ethnic minority groups (REMGs) are disproportionately underrepresented. For example, although African Americans represent 13.3% of the general population, they account for only 5.0% of patients enrolled in clinical trials.

A cohort of cancer centers was selected to serve as models for identifying key strategies for REMG engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population &ge;10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation. Together, these centers were representative of every major ethnic minority group, according to the US Department of Health & Human Services&rsquo; Office of Management and Budget race and ethnic designations.

&ldquo;These sites had high rates of enrollment of diverse populations on clinical trials by employing these strategies,&rdquo; said Marvella E. Ford, PhD, associate director of population science and cancer disparities and endowed chair of cancer disparities at the Medical University of South Carolina in Charleston, in an interview withTargeted Therapies in Oncology. &ldquo;There is correlative evidence that these strategies are working.&rdquo;

Investigators deduced that community engagement, commitment from center leadership, and patient engagement practices were among the key aspects of enrolling REMGs into clinical trials (TABLE). One strategy used by multiple institutions in the analysis was cultural competence training for staff to help in overcoming challenges and barriers to REMG participation in trials.

&ldquo;There are some issues with trust in a lot of communities, and rightfully so,&rdquo; Ford said. &ldquo;We conducted focus groups with African American community members, and they told us that all they want is for investigators to acknowledge what has happened [in the past] and not act [as if] it did not happen.&rdquo;

She went on to discuss the history of the Tuskegee syphilis trial, the results of which sowed distrust from patients—specifically those in minority populations&mdash;about the ethicality of clinical trial design. She said it is important for the medical community and investigators to acknowledge the events that occurred over 3 decades ago but also be able to identify exactly which parts of the trial were ethical violations.^{2​​​​​​​}

&ldquo;I tell people in the community that it was not unethical to start the trial on untreated syphilis because [in 1933], there was no treatment for it yet,&rdquo; Ford said. The ethical violations occurred when information about the mode of disease transmission was withheld from the patients and, later on, when investigators refused to treat them when a cure was finally realized in the 1940s.

&ldquo;We pinpoint the ethical atrocities, but we also point out all the safeguards that are currently in place because of the Tuskegee study. There are a lot of layers of protection for participants&rsquo; rights that did not exist before the Tuskegee study,&rdquo; Ford said. These include the informed consent process and data and safety monitoring practices.

Another area of misinformation surrounds the randomization process. Ford said patients always want to be in the intervention arm of a trial and think they will get subpar care if they end up in the control arm.

&ldquo;We tell patients if they have a medical condition and they are in the control group, the minimum quality of care they will receive is the gold standard of care,&rdquo; Ford said. &ldquo;A lot of people do not want to be in the control arm because they think they are going to have to stop all their medications.&rdquo; Transparency about the trial process is key for trust as well as for deeper understanding by the patients.

Another area of misinformation surrounds the randomization process. Ford said patients always want to be in the intervention arm of a trial and think they will get subpar care if they end up in the control arm.

&ldquo;We tell patients if they have a medical condition and they are in the control group, the minimum quality of care they will receive is the gold standard of care,&rdquo; Ford said. &ldquo;A lot of people do not want to be in the control arm because they think they are going to have to stop all their medications.&rdquo; Transparency about the trial process is key for trust as well as for deeper understanding by the patients.

Another area Ford outlined as important for better patient inclusivity was the use of community advisory boards and lay community representatives. In one ongoing National Institutes of Health study for which she is the lead investigator, patient navigation intervention is being compared with usual treatment for African Americans with non—small cell lung cancer who are eligible for surgical resection. The goal is to determine whether these interventions can reduce potential barriers and improve resection rates.^{3​​​​​​​}

&ldquo;For that study, we have an advisory panel that is made up of individuals from our standing advisory panel [as well as] people with specific expertise in that area,&rdquo; Ford said.

Ford also pointed out that strict inclusion criteria may be having a negative effect on the ability of centers to accrue REMGs for cancer trials. She said that unless there is a chronic condition that will specifically affect the primary outcome of interest, potential patients should be allowed to accrue on the trial.

&ldquo;If you only include African American, Latino, Asian, or Native American patients who do not have high blood pressure in a population >50 years, that is not a representative sample,&rdquo; Ford said. &ldquo;You may not be able to generalize [the results of the trial] to the population overall because the patients included in the trial may have different [characteristics].&rdquo;

Patient inclusivity is essential in the era of personalized medicine, in which treatment approaches are increasingly relying on biological factors such as race and ethnicity. Therefore, investigators are attempting to identify areas in which clinical trial accrual can be adjusted to ensure optimal inclusivity.TT​​​​​​​

References

1. Regnante JM, Richie NA, Fashoyin-Aje L, et al. US cancer centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials.J Oncol Pract. 2019;15(4):e289-e299. doi: 10.1200/JOP.18.00638.
2. 2. Brawley OW. The study of untreated syphilis in the Negro male. Int J Radiat Oncol Biol Phys. 1998;40(1):5-8. doi: 10.1016/S0360-3016(97)00835-3.
3. Project information: 4R01MD005892: improving resection rates among African Americans with NSCLC. National Institutes of Health Research Portfolio Online Reporting Tools website. bit.ly/2Dinz1w. Accessed April 17, 2019.