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ACORI Research Review: August 2022

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Reflections on ASCO 2022

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By Premal Thaker, MD, Professor of Obstetrics and Gynecology- Division of Gynecologic Oncology, Washington University School of Medicine

ASCO’s 2022 Annual Meeting, held June 3-7, 2022, was appropriately themed “Advancing Equitable Care through Innovation.” As oncologic care providers, we are charged with providing improved care to all patients regardless of socio-economic status, gender, race and ethnicity, religion, or any other social determinant of health. This is no easy task as we know historically medicine has not lived up to the four tenets of ethics: autonomy, beneficence, non-maleficence, and justice. As a community of oncology providers, we must seize the opportunity for change even though the path forward will be difficult and fraught with challenges.

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At Siteman Cancer Center in St. Louis, Missouri, we are trying to better collaborate with our community to establish meaningful relationships based on trust. Specifically, we are working closely with federally qualified health clinics that provide education, initial screening, and diagnosis of patients in our local community. Along with these key community leaders and health volunteers, Siteman cancer care professionals are trying to better understand the barriers to receiving care at our NCI-Designated Comprehensive Cancer Center, as well as the barriers to participating in clinical trials.

Siteman has started to look at our clinical trial processes more closely so that we can avoid implicit bias in offering clinical trials to more patients. Hence, Siteman Cancer Center hopes to increase equity in trial participation with more real-world eligibility inclusion criteria that can allow therapeutic breakthroughs to be applied to all patients. Fortunately, we can all learn about creative ways to address these and other pressing challenges through the collaborative work done and presented at ASCO 2022.

ACCC Has Strong Showing at 2022 ASCO Annual Meeting

At ASCO 2022 ACCC showcased six abstracts on a wide range of topics from healthcare disparities and implicit bias to virtual learning and combating burnout. ICYMI, below is a brief review of these abstracts:

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  • In light of the significant disparities in clinical research, ACCC and ASCO joined forces to pilot an implicit bias training program for clinical research teams and reported the outcomes in a poster entitled “Assessing feasibility and utility of an implicit bias training program for addressing disparities in cancer clinical trial participation.” The program was modeled after Duke University’s Just Ask™ program and consisted of virtual modules on diversity, equity, and bias in research participation. Surveys were conducted to assess participants’ knowledge and attitudes before and after the training, as well as a survey 6-weeks post-program to evaluate sustainability of changes. More than 100 individuals (126 total) from 50 research programs across the country participated in the pilot; 57% were from academic programs, 35% from hospitals or health systems, and 8% from private practice. The vast majority of participants (97%) were extremely satisfied or satisfied with the overall course content; most would recommend implementing the training program at their institution. The training was modified based on pilot participant feedback and is now available on the ACCC website at: Just Ask! Increasing Diversity in Cancer Clinical Research.
  • As part of the joint initiative referenced above, ASCO and ACCC also developed a self-assessment for trial sites to evaluate the number of patients across races and ethnicities screened, offered, and enrolled into trials throughout 2019 and 2020. Sixty-two practice sites completed the self-assessment study; 61% were academic programs, 26% were hospitals or health systems, and 13% were independent cancer programs or practices. Most sites were unable to provide the data requested at each enrollment step in the assessment. The project found that most sites did not routinely collect data for screening, offering, and consenting patients to clinical trials. Sites with missing data either did not collect data at all, did not collect data in a systematic way, or reported it would be too burdensome to manually review charts to piece together data. Without these data, it is difficult to assess if trial sites are making progress in ensuring that patients have equitable access to research. ASCO and ACCC will continue to work with trial sites to develop these important data points. The self-assessment has been modified based on pilot participant feedback and is now available online.
  • Shivakumar et al. co-authored a poster entitled “A collaborative, peer-based experience to support meaningful professional development in the evolving standards of care for HER2+ metastatic breast cancer.” This project assessed the effectiveness of a digital platform on providing education to oncology clinicians about updates in advanced HER2+ breast cancer. The platform, Gather-ed, was tested in 87 providers, 92% of whom specialized in hematology/oncology. Gather-ed uses self-study modules along with asynchronous group challenges and synchronous live group discussions to deliver concepts. 70% of learners completed all 5 self-study modules and 94% of participants reported that they either intended to make changes to their practice based on the program or that their current practice had been reinforced by the program. Participants noted that the live group discussions strongly impacted their intended practice changes. The program demonstrated high engagement levels, with an average of 6 platform interactions per learner. Overall, the Gather-ed platform led to significant professional development for oncology providers who treat advanced HER2+ breast cancer patients.
  • Another poster, entitled “Building a multidisciplinary consortium in Iowa to advance genetic counseling and testing in patients with cancer,” showcased an initiative developed by the Iowa Oncology Society in partnership with ACCC that focuses on optimizing genetic testing and counseling in oncology patients. The Iowa Oncology Society formed a multidisciplinary consortium that carried out various activities to identify barriers and determine best practices in conducting genetic testing and counseling. These activities consisted of focus groups, educational lunch and learn sessions, a working group meeting, and a podcast. The initiative revealed several important opportunities for improvement, such as: implementing creative ways to collect patient history and screen for hereditary cancer syndromes; using more effective education materials when discussing genetic counseling; improving language regarding somatic vs. genetic test results; and forming partnerships with local genetic counselors or organizations that offer telehealth services. The Iowa Oncology Society will continue to build on this work by developing additional programming and by advocating for certified genetic counselors to be recognized as healthcare providers to increase access to genetic counseling.
  • Boehmer et al. investigated disparities in bladder cancer by conducting a claims analysis of Medicare patients with bladder cancer over a 24-month period. Of the 4,356 patients identified, 28% were diagnosed at later stages and these patients incurred substantially higher out-of-pocket costs compared to patients diagnosed at early stages. For both groups of patients, the month of diagnosis is the most expensive, with 53% of all costs in that month going towards cystoscopy/TURBT procedures. The abstract, entitled “Using real-world data to assess variations in cost and healthcare utilization for patients diagnosed with bladder cancer,” concluded that earlier diagnosis of bladder cancer is essential towards not only improving outcomes but also reducing financial burden for these patients.
  • Burnout has been a common topic lately among healthcare workers, with oncology providers being no exception. In 2021 and 2022, ACCC addressed the issue of burnout in multidisciplinary oncology care team members through professional development opportunities, such as expert-led mindful meditation, virtual “Coffee Chat Learning Sessions,” and podcast episodes on well-being and resiliency. The program was presented in a poster entitled “National organization addresses multidisciplinary oncology team burnout and resiliency through multifaceted presidential theme education initiative.” Some examples of coffee chat topics included training for new staff and mentorship, integrative care for patients, strategies to address staff burnout, community service and giving, and more. Across the virtual coffee chats, meditation series, and podcast episodes, ACCC reached thousands of cancer care team members. This program served as a valuable resource to oncology providers to promote resiliency and improve well-being in a challenging time.

Addressing Cancer Disparities in the U.S. Latinx LGBTQ+ Community

Last fall, the FDA’s Oncology Center of Excellence (OCE) held a panel addressing cancer disparities in the U.S. Latinx and LGBTQ+ community in honor of LBGTQ History Month and National Hispanic American Heritage Month. Panelists were:

  • Loriana Hernandez-Aldama, two-time cancer survivor, former news personality, and patient advocate
  • Dr. Marc Pucinelli, Associate Scientist at the University of Miami
  • Olga, a Latinx and LGBTQ breast cancer survivor
  • Michelle Veras, Project Director at the National LGBT Cancer Network
  • Dr. Karen Winkfield, Executive Director of the Meharry-Vanderbilt Alliance
  • Rea Blakey, Associate Director of External Outreach and Engagement at the OCE
  • Dr. Richard Pazdur, Director of the OCE.
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The panel commenced with a review of survey results from the National LGBT Cancer Network, which found that LGBTQ+ members of the Hispanic/Latinx community generally had poor experiences in their cancer care, reporting many gaps in medical and psychosocial care throughout their active cancer journey and into survivorship. As a Latinx and LGBTQ cancer survivor, Olga shared that sometimes non-binary individuals feel afraid to see certain providers; for example, going to the gynecologist may be a struggle for someone who does not identify as female. These types of concerns can be difficult for patients to express if they do not have a strong relationship with their provider. Initial appointments are critical for establishing trust with a patient and recognizing assumptions that can damage trust is an important skill for providers to develop. For instance, it is not uncommon for providers to have assumptions on whether a patient can make it to an appointment due to lack of transportation, difficulty taking time off work, or lack of childcare, among other reasons, or whether a patient’s guest is a spouse, sibling, or other individual. Open dialogue is necessary to remove these barriers and ensure that trust is built from the first meeting with the patient.

Many disparities in social minority populations are difficult to quantify due to lack of data. Part of the issue is that our electronic health records (EHRs) have not been set up to collect information such as sexual orientation or gender identity, although many EHRs are now integrating gender identity into patient demographics information. Another key issue is the need for more training and education for healthcare providers about the needs of LGBTQ+ patients, to reduce stigmatization and raise awareness around implicit biases. One study found that oncologists reported very low levels of knowledge and comfort with treating transgender patients. There are also many assumptions around queer communities, such as if those who have breast cancer want reconstructive surgery, or whether queer patients want to talk about fertility preservation. Even one or two interactions in which the patient feels stigmatized by the provider can decrease the likelihood of the patient attending follow-up appointments. Moreover, many providers are still uncomfortable broaching conversations regarding gender identity, sexual orientation, or lower socio-economic status. Remaining uninformed or unengaged in the care of disenfranchised patients is a disservice to these communities and will continue to perpetuate disparities. Panelists emphasized that it is time for a change. Medical education should be redesigned to train clinicians to understand new social constructs and approach each patient based on their unique circumstances.

Pharmaceutical companies also share in the responsibility of embedding cultural awareness and social sensitivity into the design of new therapies and clinical trials. Dr. Pazdur shared a story about a new drug being evaluated that had significant toxicities at a particular dose but was deemed “tolerable” by the pharmaceutical manufacturer. When asked who reported that the drug was tolerable, the company claimed that the investigators did; the patients were not even part of the discussion. This represents a common scenario in medical research and highlights a critical opportunity to assess how treatments are currently being evaluated.

While oncologists have traditionally valued duration of survival as the most important efficacy endpoint, many patients may prioritize the quality of their lives. Providers need to discuss with each patient what “quality of life” means to them. Some may not value a longer life on a particular treatment if it means that the time they have will be spent ill or hospitalized. These conversations need to be conducted during the initial meetings with patients to build trust and optimize shared decision-making throughout their cancer journey, especially with underserved populations who may not have routinely received this type of open communication.

In many cases, underserved patients, such as those living in the intersectionality of Hispanic/Latinx and LGBTQ+, may delay or avoid care due to high costs and/or not having adequate health insurance. This gap further widens the healthcare disparities between these and other communities. Health insurance providers should examine the role that they have in improving accessibility to services to enhance equitable care. Disenfranchised communities need more insurance access to mental health programs and providers who are culturally sensitive.

The last theme discussed by the panel centered on the concept of “La Familia” and its significance in healthcare, particularly in the Hispanic/Latinx community. Individuals who are LGBTQ+ often become ostracized from their families, which introduces another challenge to these patients as they go through cancer care. For example, one panelist pointed out that in Miami, about 70% of the population is Hispanic/Latinx, with many of those individuals coming from places that are less accepting of LGBTQ+. Many of the patients who identify as Hispanic/Latinx and LGBTQ+ in Miami become disconnected from their families and many feel that they must endure their cancer journeys alone. It should come as no surprise that the loss of such a critical support system is a huge detriment to cancer care and outcomes.

This panel discussion highlighted many existing gaps in the cancer care of individuals who identify as both Hispanic/Latinx and LGBTQ+. Our healthcare system has a long way to go in advancing outcomes for underserved populations and ensuring that these patients receive the care that they deserve.

THREAD and Amazon Web Services Launch Cloud-based, AI-driven Decentralized Clinical Trials Technology

In an effort to modernize clinical research, THREAD® recently announced a collaboration with Amazon Web Services (AWS) to launch cloud-based, AI-driven decentralized clinical trials technologies. THREAD provides a decentralized clinical trial platform with services to support a range of needs from virtual trial design to study close-out. By using AWS’ extensive cloud platform, THREAD hopes to propel clinical research to a new standard in this digital era. Decentralized clinical trials allow for greater convenience in trial participation by reducing the number of site visits and time commitment required for patients to participate.

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The new THREAD and AWS technology looks to:

  • Reduce inefficiencies in real-time data capture by auto-populating data that is currently entered manually.
  • Reduce inefficiencies by more than 30%, resulting in cost savings of nearly 25%.
  • Leverage THREAD’s decentralized clinical trials platform to decrease the start-up time to onboard participants by up to 30%, thus expediting the ability to offer trials.
  • Make participant data more easily accessible with added security.
  • Allow customers to monitor studies more precisely.

The underlying goal: to improve data capture and storage and reduce the amount of time it takes to conduct research.

As decentralized clinical trials grow in use, we will hopefully see an improvement in diversification across studies due to the increased convenience of participation. While this is a critical goal, one concern with decentralized clinical trials is the potential loss of person-centered communication and a sacrifice of the patient-provider relationship. When leveraging the benefits of technology, the balance of technology and humanity must be carefully considered to maintain a patient-centric focus. Sponsors using when leveraging the benefits of technology should design trials to have simple user interfaces with “people-first” language. Moreover, sponsors should ensure that these designs are acceptable to the average participant and caregiver in the intended study demographic.

Decentralized clinical trials empower patients and caregivers to become key contributors of study data due to the incorporation of patient reported outcome data. This shift in responsibility puts the patient in a more active role, which can be a great motivator for many participants. From the initial recruitment and pre-trial interactions, research staff should be open to participants about the entire trial experience to mitigate any ambiguity and confusion in the trial process. Additional strategies to engage patients and caregivers include motivational messages, notifications, visit reminders, and study progress updates.

Patient comfort is vital in ensuring that patients enroll in and stay on decentralized clinical trials. Sponsors must understand patients’ routines and preferences to design trials and wearable data sensors that fit into or enhance a patient’s life, rather than hinder it. If used effectively, technology can reduce patient hurdles to research participation, ultimately expanding access to clinical trials and increasing representation among all groups of patients. The THREAD and AWS decentralized clinical trial platform is a prime example of how to “leverage technology to transform cancer care delivery and the patient experience,” the 2022-2023 ACCC President’s Theme.

Use of Race, Ethnicity, and Ancestry as Population Descriptors in Genomics Research

On April 4, 2022, the National Academies’ Committee on Use of Race, Ethnicity, and Ancestry as Population Descriptors in Genomics Research hosted a virtual public workshop as part of its second meeting. This committee was established under the National Academies of Sciences, Engineering, and Medicine to review the existing methodologies in the use of race, ethnicity, and other population descriptors in genomics research. Leading up to the workshop, the committee sought public commentary on the current use of population descriptors in genomics research and how these practices could be improved upon. The public workshop consisted of three main sessions that covered the historical, current, and future use of population descriptors in genomics research, as well as community input. The panel included a variety of scholars, scientists, and community stakeholders.

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In the first session, four panelists presented perspectives on the historical and current use of population descriptors in genomic research. Dr. Pilar Ossorio, a professor of law and bioethics at UW–Madison and co-director of the Law and Neuroscience Program, noted that much of the concern surrounding population descriptors has been on the use of race and ethnicity labels and their relations to genetic ancestry. Often, the term “population” is used loosely, in ways that can make social categories such as race and ethnicity appear to have more genetic similarity than they truly have. These conversations around population descriptors have been ongoing for decades with little resolution to the existing concerns. Dr. Ossorio suggests that instead of asking if race and ethnicity descriptors should or should not be used, the better question may be, “When, where, why, and how should we be using these descriptors?”

Following Dr. Ossorio, Dr. Joseph Graves, professor of Biological Sciences at North Carolina A&T State University and UNC Greensboro, gave a historical review of the biological race concept and Neo-Darwinism and pointed out that our social conceptions of race and ethnicity do not match underlying biological genetic variations within our species. We should not confuse the constructs that were created to oppress people with the nature of biological and genetic variations.

Dr. Andrew Clark, a population geneticist and professor at Cornell University, presented on genome-wide association studies and concluded that while human populations display differences in allele frequencies, most of the differences are small, but, in aggregate, allow one to see differences even among closely related populations.

Lastly, Dr. Rina Bliss, associate professor at Rutgers School of Arts and Science, shared that genomic population descriptors have often connoted racial differences and thereby influenced the public to see genetic clusters in racial terms. To stop this association, Dr. Bliss recommends removing racial and quasi-racial groups from genomic population descriptors and only using racial terminology when studying racism’s biological effects.

The last two sessions featured a multitude of panelists who continued the conversations on current challenges in harmonizing race and ethnicity at the global level while also discussing the future use of population descriptors in genomics research. One major theme in this workshop was the lack of harmonization in descriptions of race and ethnicity. What may be considered as a “race” in one culture may be different from another culture, thereby confounding cross-cultural comparisons across the globe. Much of the research conducted to date has used racial and ethnic categories that are distinctly North American, but there are limitations in applying these categories in an international context. Additionally, some panelists pointed out that gene sequencing may be preferable to self-reported ethnicity or investigator-prescribed racial descriptors in genomics research to establish precise and objective data. Yet, it is also important to respect an individual’s self-identification with specific racial or ethnic groups, particularly in social science research.

These conversations highlight the importance of using population descriptors appropriate to the context of the type of research being conducted. For the future, one recommendation is to consider developing world-wide acceptable population descriptor ontology, such as gene ontology or phenotype ontology, for large-scale worldwide consortia. Moreover, one panelist believes that we should prioritize the inclusion of multiple types of diversity (i.e., socioeconomic status, sex, etc.) in future research.

Overall, the experts commented on the challenges they face in the status quo with regards to their specific fields of research. This committee aims to gather all relevant viewpoints to synthesize rational and actionable guidance to inform future research. As one speaker mentioned, the National Human Genome Research Institute hopes that by 2030, "Research in human genomics will have moved beyond population descriptors based on historic social constructs such as race, but until then, research will still be conducted using social categories, with the understanding of the limitations that are inherent to that approach.”

Update on the ASCO-ACCC Initiative

In July, ASCO and ACCC jointly released resources to help research sites increase the racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The Just ASK™ Training Program and Site Self-Assessment are available free-of-charge and represent a full and complementary set of resources that can help research sites address barriers to participation in cancer clinical trials among racial and ethnic populations that have been historically underrepresented.

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The availability of the Just ASK™ Training Program and Site Self-Assessment follows the recent publication of the ASCO-ACCC Research Statement “Increasing Racial and Ethnic Diversity in Cancer Clinical Trials,” which outlines specific actions for individual stakeholders in the cancer clinical trial ecosystem to increase diversity in research participation. These recommendations—which are summarized in this illustration—focus on key areas that address barriers to cancer clinical trials.

The three resources directly address some of the recommendations in the Research Statement.

An annotated reference list of detailed strategies and resources is also available online. The list is not exhaustive. It is intended to provide examples of strategies for research sites to increase EDI in cancer clinical trials and to stimulate interest in research to establish more evidence-based strategies that result in increased participation of patients historically underrepresented in clinical trials.

The development and release of these resources is an important milestone in the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials. The initiative is led by a steering group of EDI experts, patient advocates, and other stakeholders. ASCO and ACCC formed a Patient Partners Advisory Group, which also informs the work of the collaboration, and includes cancer research advocates who represent racial and ethnic minority populations. The steering group sought to answer the call from the oncology community for tangible resources to help improve representation in cancer clinical trials – as evidenced by the eager involvement of 75 research sites in the pilot study. With the Research Site Self-Assessment, Training Program, Facilitation Guide, and Research Statement recommendations, it is ASCO and ACCC’s hope that sites feel supported and empowered to make change.

Clinical Trial Spotlight: The PROMISE Study

The Prostate Cancer Registry of Outcomes and Germline Mutations (PROMISE) study is a virtual, long-term observational study that aims to establish a nationwide registry of germline pathogenic mutations in prostate cancer patients. The PROMISE study opened last year and is actively recruiting male patients 18 years or older with a confirmed prostate cancer diagnosis (via tissue biopsy, PSA >100 ng/dL, and/or clear radiographic evidence) and receiving systemic treatment. Participants will be screened with a home-based saliva sample and baseline demographic survey that reviews family history. Those with pathogenic variants will be followed every 6 months for at least 15 years. Eligible participants will receive genetic counseling, as well as information on new treatments and research opportunities related to genetic variants. The estimated enrollment for this study is 500 participants and these participants will be screened over a five-year period.

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The primary outcome for the PROMISE study will be the frequency of germline pathogenic variants; secondary outcomes include variants of uncertain significance, association between disease characteristics and genetic variants, patient reported outcomes, analysis of longitudinal outcome data, and overall survival. The goal of this study is to understand the impact of hereditary genetics on outcomes in prostate cancer patients and to better identify treatments that those with germline mutations would derive the most benefit from. The PROMISE trial is taking place at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Memorial Sloan Kettering Cancer Center, and the University of Washington Medical Center. Prostate cancer patients at all stages of disease are encouraged to participate, and patients can enroll and participate regardless of where they live in the U.S. For more information, visit the study website at prostatecancerpromise.org.

ACCC Comments to Draft FDA Guidance to Increase Diversity in Clinical Trials

In April, the U.S. Food and Drug Administration (FDA) published draft guidance on “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials.” The FDA opened a 60-day comment period to allow stakeholders to submit feedback and suggestions prior to finalizing the guidance for clinical trial sponsors developing medical products. The purpose of this guidance is to provide recommendations to sponsors as they seek to enroll adequate numbers of clinical trial participants from historically underrepresented racial and ethnic groups and thereby ensure that the data gathered during the trial is representative of the population expected to use the medical product if approved. The ACCC Community Oncology Research Institute (ACORI) Task Force responded to these recommendations with several comments for consideration.

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First, ACORI strongly encouraged the FDA to add guidance for sponsors to collect social determinants of health data in their Diversity Plans in addition to data on race and ethnicity, as these social factors can significantly impact efficacy and outcomes. Regarding race, ACORI recommended the FDA note the difference between race as a social construct (with recognition based on phenotypic characteristics) and ancestry as a biological process to enhance clarity around these terms. Lastly, the FDA draft did not address rural vs. urban populations in the context of racial and ethnic diversity. In many parts of the country where racial/ethnic diversity is low, such as rural areas, it may be more meaningful to focus on other disparities when optimizing clinical trial enrollment, including socio-economic status, level of education, etc.

In response to recommended elements of the Diversity Plans, ACORI had several comments about specific categories. For category 2 (“scope of medical product development program”), ACORI noted that some eligibility criteria can negatively impact diversity in trials because they exclude patients who have certain pre-existing conditions or medications. ACORI recommended that the FDA acknowledge this when discussing eligibility criteria for trial enrollment. In category 3 (“goals for enrollment of under-represented racial and ethnic participants”), ACORI indicated that providing an example of Black men carrying a disproportionate burden of prostate cancer would be beneficial to illustrate the point of “increased enrollment of certain populations…to elucidate potential important differences.” For category 4 (“specific plan of action to enroll and retain diverse participants”), ACORI urges the FDA to recommend developing strategies to engage community leaders of under-represented populations about clinical trial opportunities. Lastly, for category 5 (“status of meeting enrollment goals”), ACORI suggests that the FDA should encourage trial sponsors to keep studies open to enrollment from under-represented populations or to document a plan to meet enrollment targets in the post-market setting if sponsors fail to meet enrollment goals.

While such Diversity Plans are just a recommendation for clinical trial sponsors at present, Congress is eager to make such plans a mandate in the near future. As part of the legislative package to reauthorize FDA user fees from 2022 through 2027, the U.S. House of Representatives included a provision to increase clinical trial diversity by requiring drug and medical device manufacturers to develop a clinical trial “diversity action plan” early in the development process and submit the plan to FDA. In June, this reauthorization package passed in the House with broad bipartisan support, by a vote of 392-28. These clinical trial diversity provisions are not yet reflected in the Senate version of the FDA user fee reauthorization package, so additional negotiation will be necessary to include them in the final version of the legislation, which is expected to pass prior to a September 30 deadline.