Diversity

CTTI to Launch New Diversity Recommendations at Free Public Webinar

Posted on by Hannah Faulkner

CTTI will host a free public webinar on Thursday, May 18 at 12:00 p.m. EDT to unveil new recommendations for increasing diversity in clinical trials.  

The webinar will include a welcome from Sally Okun, CTTI; opening remarks from Richardae Araojo, U.S. Food and Drug Administration (FDA); a project overview from Luther Clark, Merck; a maturity model overview from Dawn Corbett, NIH; and a panel discussion that will focus on stakeholder perspectives related to the integration of the new recommendations. 

The inclusion and adequate representation of women and historically underrepresented racial and ethnic groups in clinical trials leads to more accurate and generalizable trial results by enhancing and expanding our understanding of the safety and efficacy of investigational medical products. In addition, inclusion of all the populations who are affected by a condition can improve access to innovative and potentially life-extending and life-improving therapies, develop trust in clinical trial results, and facilitate uptake if the medical product is approved. 

As part of the Diversity Project, experts and key stakeholders from across the clinical trials enterprise developed the recommendations following CTTI’s five-step methodology designed to ensure they are actionable, evidence-based, and consensus-driven. The CTTI recommendations and supporting maturity model seek to build on the growing recognized need for long-term, transformative strategies that are rooted in a deep organizational commitment to developing clinical trial research infrastructure that is more responsive to the needs of historically underrepresented populations. 

Register for the free one-hour webinar. 

CTTI Publication Investigates Organizational Practices to Promote Diversity and Inclusion in Clinical Trials

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of Clinical Pharmacology & Therapeutics, investigates organizational-level practices for enhancing diversity and inclusion in clinical trials as one component of advancing health equity and improving health outcomes. When clinical trial participants do not reflect the populations that will use the medical product, it can limit our understanding of the safety and efficacy of the investigational medical product, restrict the availability of evidence-based treatment guidelines for vulnerable populations disproportionally burdened by disease, and delay access to innovative and potentially life-extending therapies.  

CTTI interviewed 36 senior-level leaders at 20 organizations that conduct clinical trials to gather perspectives on strategies to support diversity and inclusion in clinical research. Based on these interviews and a 2-day meeting with 53 experts, CTTI identified four key action areas to implement sustainable, organizational-level practices: commitment, partnerships, accountability, and resources. To improve equitable access and increase diversity in clinical trial populations, CTTI suggests making diversity and inclusion in clinical trials an organizational priority and defining responsibility for these efforts, establishing and maintaining bi-directional community partnerships, and allocating organizational resources that support diversity and inclusion in clinical research. The CTTI Diversity Project Team is using the findings from this research to develop recommendations and a tool for institutions to use to initiate or enhance their diversity and inclusion efforts. 

CTTI Holds Meeting to Discuss the Systemic Changes Needed to Increase Diversity in Clinical Trials

Posted on by Hannah Faulkner

The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Oct. 12 & 21 to discuss the systemic changes needed to ensure that U.S. clinical trials better meet the needs of diverse populations, including racial minorities, ethnic minorities, and women. At the meeting, leaders and key stakeholders from across the clinical trials ecosystem participated in an engaging forum, informative discussions, and lively breakout sessions that shed more light on new solutions for sharing information and ensuring sufficient resource allocation to diversity, equity, and inclusion initiatives.

Meeting attendees also identified some important themes and identified opportunities to increase diversity in clinical trials:

  • The benefits are indisputable. Including a diverse population in clinical trials improves the quality of science, enhances patient trust, increases patient recruitment and retention, and improves clinical care for all patients.
  • A culture shift is needed. Organizations need to ingrain diversity, equity, and inclusion initiatives into their portfolio-level strategy and within their overall mission. They should foster bi-directional community partnerships and directly engage patients in the design and planning of clinical trials and diversity efforts from the very beginning.
  • This is a full group effort. Increasing diversity in clinical trials is a multi-stakeholder effort that will take all groups working together to achieve goals of clinical trial populations representing the populations who are affected by disease.
  • There is important work ahead of us. Meeting attendees provided feedback on CTTI’s draft maturity model, helping to create a better public resource. Suggested additions included a focus on values and guidelines that are generalizable to a wide variety of stakeholders, not just industry stakeholders, and more guidance on how organizations can measure their progress through the maturity model.

CTTI is now using these findings – along with other research results and multi-stakeholder discussions – to develop recommendations and resources for release in early 2022. The project team may host additional webinars focusing on case studies and implementation of resources.

CTTI Announces New Playbook for Designing High-Quality, Diverse COVID-19 Trials

Posted on by Hannah Faulkner

As the pandemic continues to endure worldwide, CTTI is leading the way in uncovering best practices for conducting COVID-19 trials. Following up on its first playbook focusing on conducting successful trials during the pandemic, CTTI is now releasing a second playbook with eight essential principles for high-quality, diverse COVID-19 trials.

These elements, fully outlined in the new COVID-19 playbook, recommend that stakeholders:

  1. Learn from the past and what’s being done now
  2. Make the time to design right, but move quickly
  3. Adequately power trials
  4. Randomize trials
  5. Maintain ethics
  6. Collaborate on study design
  7. Engage and enroll racial and ethnic minorities
  8. Use a core set of inclusion and exclusion criteria and endpoints
  9. Collaborate and coordinate

Beginning in April 2020, CTTI conducted an analysis of COVID-19 treatment trials in ClinicalTrials.gov, met with key stakeholders to discuss best practices for designing these types of trials, and launched a public survey on how to engage racial and ethnic minority patient populations in COVID-19 trials. CTTI communicated the resulting best practices during two CTTI-hosted webinars on designing high-quality COVID-19 treatment trials and engaging racial and ethnic minorities in COVID-19 trials.

These resources can help researchers adapt to the changing landscape and generate meaningful evidence despite the unprecedented challenges presented by the pandemic. Learn more about what CTTI is doing to address clinical trials issues related to COVID-19.

New CTTI Project Aims to Increase Inclusion of Minority Populations in Clinical Trials

Posted on by Hannah Faulkner

The lack of diversity in U.S. clinical trials limits understanding of the risks and benefits of medical products. To address this issue, CTTI is conducting a new project to demonstrate the value of engaging racial minorities, ethnic minorities, and women in clinical trials.

The objectives of this new project include:

  • Identify organizational-level practices, and related metrics, that increase the inclusion of diverse patient populations in the development lifecycle of medical products.
  • Identify incentives & disincentives for decision-makers to invest sufficient resources in organizational-level practices that increase diversity in clinical trials.
  • Identify factors that yield a clinical, scientific, and financial return on investment from engaging diverse populations in clinical trials

CTTI will conduct in-depth interviews with key stakeholders, create real-world case studies, and develop process and outcome evaluation metrics designed to build fit-for-purpose, scalable strategies to increase diversity in clinical trials.

By collecting data that demonstrates the importance of including underrepresented patient populations, CTTI aims to help increase the participation of diverse populations throughout the development lifecycle of medical products.

Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials

Posted on by Hannah Faulkner

Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18, “Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials,” CTTI discussed the barriers to enrolling a diverse patient population and key strategies to overcome them. The presentation and full slide deck are now available here.

The webinar covers useful insights and best practices gathered from key stakeholders across the clinical trials ecosystem, including investigators, sponsors, participants, and many others.

Presenters included:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emerson Clinical Research Institute
  • Anand Shah, FDA, OC
  • Cassandra Smith, Janssen

Several CTTI efforts are underway—including conducting surveys, holding webinars, and developing resources to help the clinical trials ecosystem adapt and move forward during this pandemic.

Webinar to Share Strategies for Including Ethnically Diverse Populations in COVID-19 Trials

Posted on by Hannah Faulkner

COVID-19 disproportionately affects racial and ethnic minority communities, and clinical trial professionals are struggling to recruit the diverse participant demographic needed to find an effective COVID-19 treatment that can work for everyone.

To help, CTTI is hosting a webinar, Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials, on Thurs., June 18 at noon ET to discuss the barriers and solutions to enrolling a diverse patient population.

The webinar will summarize useful insights gathered from key stakeholders across the clinical trials ecosystem, including IRB professionals, investigators, sponsors, participants, and others. These best practices can be applied to help clinical trial teams recruit and enroll diverse populations of participants more effectively.

Anand Shah, FDA, OC, will provide opening remarks and confirmed speakers include:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emmerson Clinical Research Institute
  • Cassandra Smith, Janssen

Mark your calendar today!