Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Clinical trials improve care and save lives but need more clinician and consumer engagement Clinical trials provide essential evidence for more effective and lifesaving therapies and identify ineffective and unnecessary interventions.1 Patients taking part in clinical trials learn more about their health, play a more active role in decision making, and have better health outcomes.2 Hospitals that conduct clinical trials tend to provide better care, have more rapid uptake of newer treatment strategies and technologies, and have lower mortality rates.2 Australia is a leading destination for clinical trials, with over 1000 new trials commencing each year, representing over $1 billion in direct expenditure.3 Contributing to our success are a world-class health system, high quality research infrastructure, skilled health and research workforces, and tax incentives for research investment.1, 3 For each dollar invested in clinical trials, estimated benefits worth $5.80 are realised, mostly from improved patient outcomes and higher quality health care.1, 4 The Australian Government, in partnership with state and territory governments and other stakeholders, has introduced several reforms to increase competitiveness for clinical trial activity, including seeking to embed research as essential health system business, developing simplified and more standardised research ethics and governance systems, and making it easier to find, conduct, participate and invest in clinical research (including the National One Stop Shop and the National Clinical Trials Front Door initiatives led by the Australian Commission on Safety and Quality in Health Care).3, 5 Substantial funding has also been committed through the Medical Research Future Fund to stimulate more clinical trial activity.6 Improving the infrastructure for clinical trials is important but may fail to adequately address the most consistent impediment to clinical trial success: the failure to recruit patients, with only about half of all trials achieving the target sample size.7 The Australian governments' collective attention to systems and infrastructure is necessary but not sufficient; it needs to be matched by a focus on the people who make clinical trials work. Too often trial recruitment planning occurs without significant input from the clinicians and the population of patients on which it depends.8, 9 Awareness of and participation in clinical trials among the public is low in Australia. An estimated 95 000 Australians participated in trials in 2019, representing 0.4% of the population.3 By comparison, the per capita rate is 1.5% in the United Kingdom3 and around 2% in the United States.10 Women and vulnerable and minority groups are even less likely to be recruited,7, 8, 11 limiting generalisability of results across patient groups.11 Even in oncology, which has actively attempted to address participation rates,8, 12 only 3–5% of eligible adult patients with cancer are enrolled in trials.13 In Australia, successful growth in trial activity has yet to be matched by meaningful engagement of patients and clinicians. General practitioners, specialists and other health professionals have a fundamental role in guiding patient participation in clinical research. The advice of a trusted clinician is a significant factor in a patient's decision to participate.11 The Australian Clinical Trials Networks include hundreds of clinician researchers who collaborate to design and conduct trials that address important clinical questions and who play an active role in promoting trials to patients.14 However, most clinicians are not affiliated with these networks and face several barriers to engaging in clinical research and clinical trials. These include insufficient time to discuss trial participation with patients and inadequate information to support those discussions, and a work culture that does not promote and support research as part of health care delivery.3, 15 These and related issues are described in the recent Australian Academy of Health and Medical Sciences' report on integrating research into health care.1 It has been argued that clinicians should be taught the fundamentals of clinical trials through university courses and clinical specialty and certification programs delivered by professional bodies,13 and the topic of clinical trials should be routinely embedded in conversations between clinicians and patients.7, 16 Finding trials relevant to individual patients needs to be easier, along with access to succinct information about them. The Australian Clinical Trials website (www.australianclinicaltrials.gov.au), managed by the Australian Government, is intended to provide information and resources for consumers, health care providers, researchers and industry, but much of the information is not written in a way that is sympathetic to the needs of either patients or clinicians.7, 16 Multiple Australian websites and online resources provide general information about clinical trials including short videos in English and other languages.17-19 Some have been supported by time-limited advertising campaigns, such as the "Helping our Health" campaign in Australia in 2017–18.20 These communications can inform consumers but rarely integrate patients' perspectives on clinical trials or address known concerns.7 Different strategies will be needed for different target groups. National initiatives that deliver sustained and consistent messages could be funded by governments. More targeted messaging would best be developed through clinical trial researchers and networks that are better connected and more able to involve specific patient groups. Patients who have never heard of clinical trials, are not interested in participating, or fear being an experimental "guinea pig" may need rudimentary information and core messages that provide reassurance about health care quality and safety during a trial.11 Among minority groups, feelings of mistrust towards research and unproven interventions and a lack of accessible information can be major barriers to conversations about trial participation.21 Educating community leaders about research and clinical trials so that they can champion awareness and interest in culturally appropriate ways has been shown to build trust in the research process.7, 11 Translating information in multiple languages and involving bilingual health professionals can also support more effective communication about trials with non-English speaking patients.7 People who are already interested in participating in clinical trials may do so for different reasons and require differentiated communication strategies that reinforce existing perceptions. Healthy volunteers may be motivated by altruism, helping others, and contributing to fighting disease. Patients with health conditions may want to help others like them but may also be hoping for access to new treatments that have the potential to improve their health.11 The current Australian governments' investments in improving systems and processes for clinical trial activity need to be matched by investment in coordinated and sustained engagement with the people who are essential to successful clinical trials: clinicians and patients. There are working examples. The British governments have further strengthened their collective commitment to patient-focused clinical research across the UK. This includes active engagement at multiple levels with health care providers and members of the public as well as other stakeholders.22 Australian governments need a similar focus on clinician and consumer engagement. We provide examples of possible actions in the Box. Greater consumer involvement in all aspects of clinical trial design and conduct has the potential to deliver improved trial participation and ensures that clinical trials are dealing with issues and interventions that matter to patients. Consumers can help to make sure that potential participants are provided with relevant, understandable information to aid decisions about participation in a trial. Reducing the length and complexity of clinical trial information sheets and consent forms represents an important step in this process.23 A national, consumer-facing one stop shop could meet the needs of patients and consumers who are looking for trustworthy, reliable, and understandable information about clinical trials. The National Clinical Trials Front Door is intended to be "a public facing website that acts as a central access point to facilitate connectivity for health researchers, sponsors, industry, primary carers, allied health and the community".5 This leaves out many clinicians, including hospital-based doctors and nurses, and specialists in private practice.5 Such a resource needs to be designed with clinicians and consumers, and needs more than "one door" to allow consumers with different languages, information needs, and interests to enter. Even with these improvements, more is needed. Sustained marketing and education campaigns are necessary — funded by federal, state and territory governments and delivered nationally as well as locally — to raise awareness of the benefits of clinical trials and how people can get more information. Clinicians also need accessible, easy to understand information about clinical trials, and need to be incentivised to talk with their patients about them, for example, by changing job descriptions to include opportunities and time for clinical trial engagement and annual reporting of such activity, such as using existing continued professional development mechanisms. Once patients join a clinical trial, researchers need to ensure that participants have positive experiences, and that both participants and their clinicians are well informed about the outcomes so that they become advocates for participation in the next trial. If we really want more successful clinical trials in Australia, we need more focus on the people who need to be engaged. If trials remain dominated by researcher and industry cultures and address only systems and infrastructure, we are unlikely to break the cycle of poor recruitment and less definitive outcomes. Open access publishing facilitated by The University of Sydney, as part of the Wiley - The University of Sydney agreement via the Council of Australian University Librarians. No relevant disclosures. Not commissioned; externally peer reviewed.

Informed Consent

Previous abusive clinical trials have caused several obstacles in recruiting African Americans for clinical trials today. The memory of the Tuskegee Syphilis Study alone remains a hard pill to swallow and is a constant hindrance to recruiting potential African Americans specifically males, for clinical trials. The basic trust that African Americans have for physician researchers, U.S. government doctors, U.S. government-sponsored research, and biomedical research in general has been seriously, although not irrevocably, breached. The purpose of this study was to gain an understanding of the knowledge, attitudes, and beliefs African Americans have that support decisions to either participate or not participate in a clinical trial. Specific areas that were examined by perceptual and demographic measures included: knowledge of clinical research processes, perceptions of clinical research purposes and procedures, advantages and disadvantages for the individual of participation in clinical research trials, characteristics of current and past participation in clinical research trials, exposure to selected experiences which are preliminary to participation in clinical research trials, perceptions regarding the need for selected changes in preparation for participation in clinical research trials; and selected personal demographic characteristics: gender, age, marital status, education level, employment status, household income, distance from research center, and overall health status. The survey method was utilized in this study. The discriminant analysis model was used to determine if a model existed that significantly increased the researcher's ability to correctly classify volunteers on their participation status in clinical research trials. The overall model was meaningful and successful in correctly classifying 74.6% of the original grouped cases. The strongest findings suggest that African Americans are likely to participate in future clinical trials based on their knowledge and perceptions of clinical research trials. Principal Investigators and research teams which focus on African Americans in clinical research trials should therefore place an increased emphasis on strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to African Americans, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

Perioperative Cardiac Research Considerations During the Coronavirus Disease 2019 (COVID-19) Pandemic

620 Creating a culture of clinical research in the clinic: Integrating clinical trials into the care of patients with lupus

BackgroundDespite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies.MethodsWe describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women’s College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial.DiscussionThis study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients.Trial registrationThe trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

The unprecedented situation we are facing has strongly disrupted the clinical research rules. Nevertheless, for the scientific community, it may represent the opportunity to learn important lessons. The COVID-19 pandemic suggests that it is possible to alleviate redundancy in clinical trials, and while preserving the rigour of a study, can offer a new, less burdened and more inclusive vision of clinical research for the scientific community of tomorrow. This perspective article describes clinicians’ vision of how the pandemic could change the roles of clinical research. Since the beginning of the SARS-COV2 outbreak in Wuhan, more than 24 million people have been infected all around the world and more than 800 000 have died from the disease so far. In this scenario, Europe is facing one of the worst crises that our National Health Systems have ever encountered in the last 50 years. Six months after the first COVID-19 diagnosis, the lockdown is being eased in European countries and our lives are slowly adapting to ‘a new normality’. Providing care to immunocompromised patients with cancer during this pandemic has been extremely challenging and oncologists face many challenges in providing cancer care during the COVID-19 outbreak. Data from China reported that patients with cancer who are infected with COVID-19 are at 3.5 times the risk of requiring mechanical ventilation or intensive care unit (ICU) admission, compared with the general population.1 Additionally, the limitation of resources in outpatient settings, including administrative staff and specialists, has hindered the routine care of patients.2 National and international cancer societies published priority-driven guidelines for the management of oncohaematological patients on therapy during the COVID-19 pandemic and recommended considering treatment delays and modifications on a case-by-case basis, taking into account the characteristics of the patient and the disease.3 In addition to routine patient care, the imperative of …

Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google.Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials.

Recommendations from national regulatory agencies for ongoing cancer trials during the COVID-19 pandemic

The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials. We performed a prospective cross-sectional survey of the Canadian public aged 18yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive. We included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively. There is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.

The participation of underserved ethnic minorities in clinical research is critical to achieving progress in cancer control. Ethnic minority patient accrual in clinical trials is a formidable challenge that requires patient trust, commitment, and overcoming of barriers. Racial and ethnic minorities make up about 40% of the United States population, yet are not well represented in research studies. Less than 10% of all patients with cancer enrolled in clinical trials are minorities. Diverse participation may lead to more generalizable results for under-represented groups, more best practices for prevention and treatment to specific minority groups, increase in knowledge and awareness of disparities about cancer, and a more accurate reflection of the United States' increasingly diverse population. Although there is a proliferation of patient navigation programs to increase health care among the underserved, there is little known on its potential effects as a strategy to enhance minority clinical trial and biospecimen accrual. City of Hope has built a functional and sustainable program for addressing health inequity, which includes training a network of community research navigators (CRN) to address gaps in knowledge, medical mistrust, and access, and navigate participation and engagement of under-represented groups in research. The research navigator program draws from the patient navigation and promotora model and is a novel and innovative application to this approach. This approach has utility and applicability to address research participation barriers, including trust and referrals. It promises sustainability and cost effectiveness as trained CRNs can deliver the program. The Community Research Navigator (CRN) project enhances community advocates' capacity by training community health leaders/promotoras as community research navigators (CRN) to widen the dissemination of the clinical trial and research participation enrollment for increased ethnic minority participation in clinical trials and health-related research. CRNs attended a 1-day training on clinical trials and research. The training included educating and encouraging individuals to proactively think about and discuss clinical trial participation with their family, friends, and health care providers; disseminating information about specific research studies, targeting the African and Latino communities; and referring individuals to specific biospecimen, clinical trials, and population studies. In total, we trained and mentored a team of 14 CRNs. Participants were 24-66 years old; most were female (86%), Latino (69%), and single (43%). After participating in the training, participants were more likely to correctly define HIPAA (p=.040) and the types of clinical trials (p=.038). In addition, CRNs were more likely to encourage clinical research participation among their family after the training (p=0.034). Further, we measured confidence in various domains, including: increase in confidence in describing the purpose and process of clinical research (p=0.006); educating minority communities about clinical trials (p=0.045); and providing informational workshops/forums on clinical research (p=0.046). Participants had an increase in overall confidence (p=.033). Our findings demonstrate that the CRN strategy holds promise in increasing minority participation in cancer clinical trials. It is an innovative application of the extensively studied patient navigation approach that warrants research. Future research should focus on the CRN project as a cost-effective tool for enrollment and retention of ethnic minorities in cancer clinical trials and the potential of enhancing clinical trial understanding outcomes among participants. Citation Format: Marisela Garcia, Mayra Serrano, Alejandro Fernandez, Katty Nerio, Kimlin Ashing. Community research navigators: The bridge to increasing ethnic minority participation in clinical research [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A25.

COVID 19 has brought race disparities to the forefront as part of a national dialogue and upset. Those of us that are people of color or do research in this space are not surprised. The reality is that despite the numerous reports and efforts that have so keenly highlighted race disparities and recommendations to address them, we have yet to truly move the needle to improve the health of black and brown people. Interestingly, COVID 19 has caused a national pivot among funding agencies to add research around COVID-19 to their current funding portfolios as enhancement awards or RFAs specific to the pandemic, quickly emerged requiring a rapid response. The value and need for this pivot given this monumental time in global health history is necessary. Yet to what extent are we thinking carefully and deliberately about the importance of diversity in our clinical research and trials to ensure our findings positively impact the populations who are hardest hit and carry the greatest burden of the disease, namely African Americans and other people of color. This a fundamental question and poses an opportunity for us to do something different than what has been our historical pattern. It is well documented that a lack of diverse participation in clinical research and trials is a national problem, where in most studies disproportionally engage white men and women more than any other race and ethnic group. For example, in a recent publication the authors found that 96% of prostate cancer research study participants are white men, in a disease in which black men have the highest incidence and mortality than any other race and ethnic group. National studies engage thousands of patients in clinical research, trials, registries and biobanks but on average have less than 20% of participants from underrepresented race and ethnic groups. This is a far cry from national representation of race and ethnic groups of color and has clear implications that in essence perpetuates the disparities we seek to reduce or eliminate. Lack of diversity in research participation limits our ability to accelerate research and improve population health more broadly. For example, it limits generalizability of findings from the development of effective therapeutics to dissemination and implementation of evidence-based methods to increase screening, treatment, and quality of care are critical, all critical points care points highlighted by COVID-19. It excludes or limits access to cutting edge and potentially life-saving therapies that may have the potential to ease the burden of disease and death for people of color. Essentially, access to clinical research and trials is a social justice and an equity issue and without deliberate and intentional diversity strategies being initiated as we develop and design studies, we are adding to the ongoing sickness and death or preventable diseases among people who are black and brown, this particularly true in the case of COVID 19, cancer and other chronic diseases. While diversity in clinical trials to improve population health and advance racial equity is critical, COVID 19 has presented added challenges and opportunities to address the lack of diversity in oncology clinical research, trials, and biobanking. The very nature of a pandemic requires rapid response, action with a heightened sense of urgency, and some would argue, fear of the unknown. Add these key factors to the well-known points that influence lack of diversity in clinical trials including race and ethnic minorities not being asked or informed about clinical trials, assumptions made by research teams that suggest implicit biases, lack of an overarching diversity strategy embedded in recruitment strategies, lack of accountability -despite the requirement to complete the minority enrollment table, and a paucity of authentic community and stakeholder partnerships that have the ability to build trust and bolster diversity in clinical research before, during and post the pandemic and across an array of diseases, the outcomes could seem dismal. However, addressing these key elements can yield invaluable outcomes, namely improved health and quality of life, preventing avoidable deaths, and equity. This presentation provides key recommendations to advance equity and move the needle in increasing diversity in oncology clinical research and trials, a national imperative. Citation Format: Nadine J. Barrett. The Compelling Imperative to Diversify Participation in Clinical Trials and Research [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr IA02.