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  1. 2023 OCE Annual Report

Fostering Diversity in Drug Development

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AR 2023 Purple

OCE's communication and educational efforts include outreach to diverse communities to help eliminate health inequities and reduce the burden of cancer. Three OCE projects that foster diversity in oncology drug development describe their 2023 accomplishments here. 

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Project Community 

Project Community leads the OCE’s outreach to patients with cancer in the U.S., their families and caregivers, and underserved cancer communities. Primary outreach and engagement initiatives continued in 2023 for the "Conversations on Cancer" public panel discussions and the National Black Family Cancer Awareness campaign. Project Community expanded to include an international collaboration with the European Medicines Agency (EMA) and the publication and distribution OCE’s first advocate-focused newsletter, OCE ENGAGE. Project Community aligns with the White House Cancer Moonshot goals and the National Cancer Plan goals to Eliminate Inequities, Engage Every Person, and encourage all patients and families to learn to Detect Cancers Early.

The 3rd Annual National Black Family Cancer Awareness Week—Engaging the Generations featured a corresponding "Conversation on Cancer" public panel discussion. Visit our webpage to see video of celebrity cancer advocate and TV actress/producer Chandra Wilson in the discussion recorded June 15, 2023. You’ll also find a brief video featuring another celebrity cancer advocate, TV and film actress, Sonequa Martin-Green, who was a panelist on February 16, 2023. The weeklong #BlackFamCan campaign also supported the following White House Cancer Moonshot goals: 

  • Closing the screening gap 
  • Understanding and addressing environmental exposure 
  • Engaging the Generations (official #BlackFamCan tagline supporting Juneteenth and Father’s Day weekend) 
  • Decreasing the impact of preventable cancers 
  • Bringing cutting edge research through the pipeline to patients and communities 
  • Supporting patients and caregivers

FDA Commissioner Robert Califf was featured as a recorded participant in a Project Community “Conversation on Cancer.” His comments about medical risks due to cancer misinformation are also on the webpage, where you can watch recordings of all the 2023 public panel discussions hosted by Project Community.

“Conversations on Cancer” Public Panel Series 

  • January 18: Seasons of Change: Oncology Careers
  • February 16: Black History Month Program, What's on the Horizon: Historically Black Colleges and Universities in the Future of Cancer Care (Celebrity Panelist: Actress Sonequa Martin-Green)
  • March 28: Advancing a more Equal Future for AA&NHPI Patients with Cancer
  • April 25: Beginning the Rare Cancer Journey: Charting the Best Path to an Accurate Diagnosis
  • May 4: Cancer Misinformation: Truth or Consequences
  • June 15: National Black Family Cancer Awareness Week—Engaging the Generations (Celebrity Panelist: Actress Chandra Wilson)
  • July 25: Cancer Disparities in Appalachia
  • October 19: Living with Metastatic Breast Cancer (International collaboration with EMA)

Project Community led meetings between patient advocacy groups, social groups, faith-based organizations, cancer survivors, and FDA clinical reviewers.  Topics centered on outreach and engagement with OCE, increasing access to cancer clinical trials for underrepresented patients, environmental factors associated with cancer risk, cancer survivorship, prostate cancer, breast cancer, sarcoma, pancreatic cancer, liver cancer and advocates’ interests. 

Project Community hosted engagement meetings and participated in multiple, national meetings, and panels. Several of the most prominent include the following events:

  • Three 2023 National Black Family Cancer Awareness Week Community Forums, Jan. 12, March 16 and May 18, convening hundreds of external stakeholders through webinars leading up to the social media week. Collaborated with Health and Human Services agencies and Equity Newsletter, National Cancer Institute (NCI), major NCI-Designated Cancer Centers, American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), advocacy groups, community organizations and families.
  • Attended NCI-Designated Case Comprehensive Cancer Center's “Cancer Disparities Symposium,” March 2-3.
  • Convened and moderated AACR – OCE Project Community session with Scientist to Survivors patient advocates at 2023 annual conference, April 17. 
  • Convened and moderated ASCO in-person OCE session with patients and advocates, June 4.
  • Coordinated podcast episode with Morehouse School of Medicine promoting National Black Family Cancer Awareness Week, June 13.  
  • Coordinated ASCO CancerNet podcast content June 13.

New Videos on Cancer Community Resources 

  • Importance of Scheduling and Updating Cancer Screenings
  • How are Cancer Drugs Approved?
  • Importance of Minority Students in Cancer Careers
  • What is Accelerated Approval?
  • What is OCE?  
  • Engaging the Generations

 

Project ASIATICA

Following the March 28, 2023, Conversations on Cancer – Advancing a More Equal Future for AA & NHPI Patients with Cancer and in honor of Asian American, Native Hawaiian, and Pacific Islander Heritage Month, OCE launched Project ASIATICA (ASian amerIcans, nATive hawaIian, and other paCific islAnders) in May 2023. 

This initiative aims to 1) bring greater awareness and understanding of the challenges and health disparities faced by AA & NHPI patients with cancer, as cancer is the leading cause of death for AA & NHPI communities; and 2) advance health equity for AA & NHPI patients with cancer through a focus on advocacy, research, and policy. 

In 2023, OCE Project ASIATICA:

 

Project Equity

In 2023, Project Equity continued to foster adoption of the recommendations provided for in FDA draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials, a cross-center guidance that provides recommendations to sponsors on the development and submission of diversity plans to the FDA. 

Project Equity posted two key presentations on its web page:

  • A report analyzing Diversity Plan submissions to CDER oncology divisions during the first year following publication of the draft guidance.
  • An overview of clinical trial diversity from the OCE perspective, discussion of FDA guidance on Diversity Plans, and new legislation relevant to clinical trial diversity.

Project Equity also participated in Agency-wide initiatives to implement the requirements under The Food and Drug Omnibus Reform Act of 2022 (FDORA) to plan and convene a virtual public workshop to enhance clinical study diversity, and to update existing guidance or develop new draft guidance describing the content and format of Diversity Action Plans as required under FDORA. Project Equity conducted outreach and engagement activities to promote OCE’s priorities on diversity, obtain feedback from stakeholders on its diversity agenda, and inform OCE’s policy discussions and activities on the topic. This work resulted in co-authorship in 10 peer-reviewed publications, and 28 invited external speaking opportunities with audiences that included members of academia, pharmaceutical industry, patient advocacy, and other regulatory authorities, and contributed to clinical research training programs as faculty. Project Equity also serves as a subject matter resource for other offices across FDA medical product centers.

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