Q&A: Racial disparities in multiple myeloma clinical trials impact quality of results
Click Here to Manage Email Alerts
Key takeaways:
- Lack of diversity results in insufficient data regarding treatment safety and efficacy.
- African American and Hispanic patients are significantly underrepresented in clinical trials for multiple myeloma.
Racial disparities continue to exist in clinical trials for patients with multiple myeloma. Along with enrollment barriers and the COVID-19 pandemic, patients with multiple myeloma face challenges for enrollment.
When population groups are underrepresented in clinical trials it can create insufficient data regarding treatment safety and efficacy, and can impact the quality of scientific evidence, according to Srinivas Devarakonda, MD.
Devarakonda, an associate professor at The Ohio State University Comprehensive Cancer Center, spoke with Healio about the racial disparities in clinical trials for patients with multiple myeloma.
Healio: How do clinical trials impact practice in multiple myeloma treatment selection?
Devarakonda: Clinical trials are important research tools that help advance our knowledge about a particular cancer and improve the treatment methods. They are important to investigate if a particular drug or combination of drugs given at a certain dose and frequency — often called a treatment regimen — works for a particular cancer.
Knowledge about common side-effects, possible adverse events and complications of experimental drugs is obtained from clinical trials. They can also provide valuable information about the biology of the cancer and any differential behavior in patients belonging to different racial and ethnic groups. Oncologists rely on the evidence based on the results of clinical trials while selecting a treatment regimen for multiple myeloma.
Healio: Are there underrepresented groups in clinical trials for multiple myeloma? Why would this be an issue?
Devarakonda: African American and Hispanic patients are significantly underrepresented in clinical trials for multiple myeloma. This is despite the fact the incidence of multiple myeloma in African Americans is twice that of Caucasians. Also, African Americans comprise 20% of the patients with multiple myeloma in the United States. Underrepresentation of certain racial and ethnic groups in clinical trials for multiple myeloma impacts the quality of scientific evidence.
Lack of diversity in clinical trial enrollment results in insufficient data regarding treatment safety and efficacy. Also, the results of such trials cannot be generalized, as the cancer behavior and response to treatment can vary significantly among racial and ethnic groups. This leads to suboptimal care and inferior clinical outcomes for the underrepresented groups.
Healio: What barriers exist for patients trying to enroll in clinical trials? How can access be expanded?
Devarakonda: Several barriers exist. They can be categorized into three categories:
1. Environmental: Living in a low-income community deprives patients of the opportunity to know about clinical trials and participate in them — made even more difficult due to poor availability of resources. Also, living in remote areas away from academic centers where clinical trials are usually conducted compounds the problem of inability to enroll in clinical trials. Lack of clinical trials at community centers, where most patients receive their care, is also another barrier to accrual.
2. Systemic: These pertain to the scientific aspects of clinical trials, attitudes of health care providers and institutional barriers. They include:
- clinical trial eligibility criteria that do not consider race-specific changes in the reference ranges for lab values or exclude patients with coexisting medical conditions;
- provider bias — both implicit and explicit — that patients belonging to a certain racial/ethnic group would not be interested in clinical trials, or they wouldn’t be compliant; and
- systemic racism at the institutional level — lack of diversity among health care providers in the clinical and research teams contributes to lack of trust, poor compliance and clinical trial enrollment; lack of support from providers in terms of exploring and offering medication assistance through grants.
3. Socioeconomic:
- lack of insurance: underrepresented minorities are often in the low-income group — for example, African Americans make up 13.5% of the U.S. population, yet 20.1% are at the poverty level; ack of insurance makes cancer care economically burdensome and clinical trial enrollment difficult;
- low health literacy — leading to lack of awareness and understanding of clinical research and medical advances, precluding inquiries about options for clinical trials with their oncologists, as well as long and complex consent forms dissuading many patients from considering clinical trials for their cancer care;
- misconceptions about clinical trials and general mistrust in the health care system;
- lack of social and/or family support needed to participate in all the clinical trial-related activities;
- lack of transportation to academic centers, where clinical trials are usually conducted; and
- compounding cost of myeloma treatment — especially copays with oral meds — and poor institutional support at the local level to help with grant application.
Healio: How has COVID impacted clinical trial enrollment?
Devarakonda: The COVID-19 pandemic disrupted clinical research activities throughout the world and significantly impacted clinical trial enrollment. Social distancing and quarantines made contact between patients and research team members difficult, thereby impacting study visits and follow-up essential to the safe conduct of clinical trials. There was also a severe shortage of staff during the COVID-19 pandemic, forcing several institutions to halt clinical trial enrollment completely. There were long operational gaps in ongoing clinical trials due to reallocation of personnel and resources toward caring for patients with COVID-19.
Healio: How can future trials for multiple myeloma address these disparities?
Devarakonda: There are many ways, which include:
- Appointment of diversity officer from the time of trial design through enrollment can help ensure equal representation of all racial and ethnic groups in the clinical trials.
- Increasing racial and ethnic diversity in the staff and providers will improve patient-provider racial concordance and trust, thereby leading to increased acceptance of clinical trials by minorities.
- Broadening eligibility criteria for clinical trials to include ethnicity/race-related cut-offs for hematologic parameters and allowing patients with controlled comorbidities will reduce the screen failures for minorities and increase their enrollment.
- Industrial sponsors should include states and cities with the highest African American and Hispanic populations for clinical trial sites.
- Academic centers should involve community oncology clinics (where most of the African American community live and approach for their cancer care) in clinical trials involving cancer therapies. This will not only increase access to racial and ethnic minorities but will also help with faster enrollment.
- Partnering with community through cancer support groups, patient advocates and previous trial participants can help reach a wider population and improve accrual of minorities to clinical trials.
- Simplifying the language of consent forms and the enrollment procedure will help make the process easier for patients and increase the accrual.
- Academic centers should consider collaboration with community practices to make them sub sites for the clinical trials and allow patients to receive treatment locally. This will greatly help patients that are limited in resources, live far away and dependent on others for transportation to be part of clinical trials.
- Outreach programs involving communities with predominant African American and Hispanic populations to increase awareness and knowledge about clinical trials using pamphlets and brochures, presentations at health fairs and churches will help clear misconceptions about research and improve enrollment.
- Engaging industry sponsors to make commitment to enroll a certain percentage of minorities in clinical trials that is equivalent to their disease prevalence, and not close the trial until that goal is met.
- FDA should strictly enforce the minority enrollment goal for clinical trials being submitted for approval (registrational clinical trials).
For more information:
Srinivas Devarakonda, MD, can be reached at devarakonda.14@osu.edu
Collapse
Healio interviews
Read more about
Click Here to Manage Email Alerts