You are leaving Medscape Education
Cancel Continue
Log in to save activities Your saved activities will show here so that you can easily access them whenever you're ready. Log in here CME & Education Log in to keep track of your credits.
 

CME / ABIM MOC / CE

Are Black and Minority Groups Underrepresented in Oncology Clinical Trials?

  • Authors: News Author: Nancy A. Melville; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 11/4/2022
  • Valid for credit through: 11/4/2023
Start Activity

  • Credits Available

    Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.25 ABIM MOC points

    Nurses - 0.25 ANCC Contact Hour(s) (0 contact hours are in the area of pharmacology)

    Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)

    Physician Assistant - 0.25 AAPA hour(s) of Category I credit

    IPCE - 0.25 Interprofessional Continuing Education (IPCE) credit

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for hematologists/oncologists, internists, nurses, nurse practitioners, physician assistants, pharmacists, hospice and palliative medicine clinicians, and other members of the healthcare team for patients with cancer.

The goal of this activity is for learners to be better able to describe the extent to which clinical trial (CT) samples in the FDA databases match the demographic and geographic diversity of populations affected by hematologic malignancies, including acute lymphoblastic leukemia (ALL), multiple myeloma (MM), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), and chronic myeloid leukemia (CML).

Upon completion of this activity, participants will:

  • Describe the extent to which CT samples in FDA databases match the demographic and geographic diversity of populations affected by hematologic malignancies, according to an analysis of CTs leading to FDA approval of drugs for various blood cancers and corresponding populations in the Surveillance, Epidemiology, and End Results (SEER) database
  • Determine clinical implications of the extent to which CT samples in FDA databases match the demographic and geographic diversity of populations affected by hematologic malignancies, according to an analysis of CTs leading to FDA approval of drugs for various blood cancers and corresponding populations in the SEER database
  • Outline implications for the healthcare team


Disclosures

Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships.


News Author

  • Nancy A. Melville

    Freelance writer, Medscape

    Disclosures

    Nancy A. Melville has no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer
    Medscape, LLC

    Disclosures

    Laurie Barclay, MD, has the following relevant financial relationships:
    Formerly owned stocks in: AbbVie Inc.

Editor/Compliance Reviewer

  • Yaisanet Oyola, MD

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Yaisanet Oyola, MD, has no relevant financial relationships.

Nurse Planner

  • Leigh Schmidt, MSN, RN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.

Peer Reviewer:

This activity has been peer reviewed and the reviewer has no relevant financial relationships.


Accreditation Statements



In support of improving patient care, Medscape, LLC is jointly accredited with commendation by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 0.25 Interprofessional Continuing Education (IPCE) credit for learning and change.

    For Physicians

  • Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.25 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

    Contact This Provider

    For Nurses

  • Awarded 0.25 contact hour(s) of nursing continuing professional development for RNs and APNs; 0.00 contact hours are in the area of pharmacology.

    Contact This Provider

    For Pharmacists

  • Medscape designates this continuing education activity for 0.25 contact hour(s) (0.025 CEUs) (Universal Activity Number: JA0007105-0000-22-367-H01-P).

    Contact This Provider

  • For Physician Assistants

    Medscape, LLC has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.25 AAPA Category 1 CME credits. Approval is valid until 11/4/2023. PAs should only claim credit commensurate with the extent of their participation.

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

CME / ABIM MOC / CE

Are Black and Minority Groups Underrepresented in Oncology Clinical Trials?

Authors: News Author: Nancy A. Melville; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 11/4/2022

Valid for credit through: 11/4/2023

processing....

Clinical Context

In the United States in 2021, hematologic malignancies accounted for ~ 10% of all cancer incidence and deaths. Healthcare disparities in blood cancers are an ongoing problem.

Race, ethnicity, and age are linked to survival differences, partly because of health care-related barriers experienced by racial minorities and older adults. Unequal distribution of trial sites warrants examination of their geographic accessibility.

Study Synopsis and Perspective

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM) compared with the proportions of these groups in the broader patient population, a new study concludes.

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the US population,” said the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Augusta, Georgia.

“Trials should represent the population with the disease,” they commented.

The study was published online August 9 in the Journal of Clinical Oncology.[1]

“This study confirms that the US cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” commented the authors of an accompanying editorial.[2]

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” said Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.

They posed the question, for instance, that as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies -- and drug labels -- to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”

Analysis of Pivotal Trials

For their study, Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the FDA between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, whereas about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 70.1 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Blacks had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanics were the highest representation, with percentages ranging from 2.9% of MM trials to 11.5% in ALL trials.

Inconsistent With Patient Populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the US Surveillance, Epidemiology, and End Results [SEER] database).

For example, Whites made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CLL, with Whites accounting for 90.5% of participants in clinical trials vs 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 vs 77.3% (P = .0389).

For Blacks, Asian/Pacific Islanders and Hispanics, across all 5 cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that female persons were overrepresented in clinical trials for 2 blood cancers. For MM, trial participation was 44.7%, whereas disease incidence was 41.7% (P < .0001), and for CML, the proportions were 44.7% vs 39.5% (P = .0009); however, female persons were underrepresented in a third blood cancer: In AML, the proportions were 44.7% vs 60.5% (P < .0001).

Geographic Location of Trials Often Inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, south Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they reported. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”

Further Action Needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors noted.

For oncology, the American Society of Clinical Oncology (ASCO®) has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Cortes and colleagues suggested another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they said.

Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Chandhok reports honoraria from Clinical Care Options and Healio and a consulting role with SERVIER. Sekeres reports a consulting role with Celgene Corporation; Kurome Therapeutics; Millennium Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Pfizer, Inc.; and Syros Pharmaceuticals and institutional research funding from Actuate Therapeutics, Inc. (Inst); Bio-Path Holdings, Inc. (Inst); Bristol-Myers Squibb Company; Pfizer, Inc.; SELLAS Life Sciences Group (Inst), and Takeda Pharmaceuticals North America, Inc.

Study Highlights

  • Of clinical trials leading to drug approval identified using FDA databases, 41 (67.2%) reported data on race and 20 (48.8%) on ethnicity.
  • Of 13,731 total participants, 11,209 (81.6%) were White, 3.8% Black, 9.1% Asian/Pacific Islanders, 0.12% American Indians/Alaskan Natives, and 1.5% other.
  • Average age ranged from 41.7 to 70.1 years; 54.8% were male.
  • Among trials reporting ethnicity, Hispanics had highest representation, ranging from 2.9% in MM trials to 11.5% in ALL trials (4.7% overall; 7.6% in CML trials).
  • Among minorities, Asian/Pacific Islanders and Blacks had highest representation in CML trials (12.7% and 5.3%, respectively) and lowest in CLL (3% and 1.1%, respectively).
  • For Blacks, Asian/Pacific Islanders, Native Americans and Hispanics, across all 5 cancer types analyzed, the proportion of participants in clinical trials was significantly lower than in the patient population.
  • Whites comprised 80.3% of participants in MM trials but only 68.7% of the MM population (P < .0001); respective percentages were 90.5% vs 82.5% (P < .0001) for CLL and 79.6 vs 77.3% (P = .0389) for AML.
  • Female persons were overrepresented in clinical trials for MM (trial participation, 44.7%; disease incidence 41.7%; P < .0001) and CML (44.7% vs 39.5%; P = .0009) but underrepresented in AML (44.7% vs 60.5%; P < .0001).
  • Male persons were underrepresented in MM (55.3% vs 60.2%; P < .0001) and CML (55.2% vs 62.9%; P < .0001).
  • For all malignancies except MM, geographic distribution of trials showed inadequate regional and state participation compared with mortality.
  • For AML, mortality rates were high across the United States, but clinical trial centers were mostly in the Northeast, with none in the Midwest.
  • Key regions with high rates of AML mortality, low access to trials, and high minority representation included east of the Carolinas, south Georgia, Alabama, and Mississippi.
  • The investigators concluded that there are significant demographic and geographic underrepresentation and imbalances in pivotal clinical trials leading to drug approvals for blood cancers compared with the affected populations.
  • These clinical trials have underrepresented Black, Native American, and Hispanic patients and women.
  • Clinical trials generally represent a younger age than reported in epidemiologic databases.
  • Geographic distribution of clinical trial sites does not fully represent geographic distribution by mortality.
  • The findings suggest that data and knowledge generated from pivotal clinical trials in hematologic malignancies are not representative of the general population, which may contribute to racial/ethnic disparities in cancer outcomes.
  • Trials should represent the population with the disease and should be within reach of patients in areas of need.
  • Standardized reporting of clinical trial participant demographics is needed.
  • Disparities must be addressed to ensure applicability of results to all relevant populations.
  • Recent initiatives to reduce disparities and improve minority representation in clinical trials include the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, International Conference for Harmonization guidance, and the new Equity, Diversity, and Inclusion Action Plan by ASCO® in 2021.
  • An accompanying editorial questioned the generalizability of drug safety and efficacy to minority populations, given potential racial/ethnic differences in drug metabolism and biologic targets.

Clinical Implications

  • There are significant demographic and geographic underrepresentation and imbalances in pivotal clinical trials leading to drug approvals for blood cancers compared with affected populations.
  • These disparities must be addressed to ensure applicability of results to all relevant populations.
  • Implications for the Healthcare Team: Drug safety and efficacy data may not be generalizable to minority populations; therefore healthcare team members must be aware of current disparities with clinical trials in hematologic malignancies to prevent disparities in future population outcomes.

 

Earn Credit