Author: Hannah Faulkner
Recording Now Available: CTTI Webinar Unveiling New Recommendations on Increasing Diversity in Clinical Trials
A recording of CTTI’s May 18 webinar unveiling the new recommendations on increasing diversity in clinical trials is now available.
The one-hour webinar includes 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 moderated by Sara Calvert, CTTI. The panel discussion focused on stakeholder perspectives related to the integration of the of the new diversity recommendations and included Ruma Bhagat, Genentech-a member of the Roche Group; Tesheia Johnson, Yale; Jane Williams, Syneos Health; and Glendon Zinser, Susan G. Komen.
The goal of creating these diversity recommendations is to increase the inclusion and adequate representation of women and historically underrepresented racial and ethnic groups in clinical trials to facilitate more accurate and generalizable trial results by enhancing and expanding our understanding of the safety and efficacy of investigational medical products. These recommendations were developed in collaboration with experts and key stakeholders from across the clinical trials enterprise using CTTI’s five-step methodology designed to ensure they are actionable, evidence-based, and consensus-driven. The first phase involved gathering input through qualitative, in-depth interviews with senior-level leaders at organizations conducting clinical trials to gather perspectives on strategies to support diversity and inclusion in clinical research. The recommendations were drafted and refined with input from a multi-stakeholder project team and through a 2-day Expert Meeting.
View the slide deck to read more.
CTTI to Launch New Diversity Recommendations at Free Public Webinar
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 Holds Meeting to Discuss Engaging Stakeholders in Trial Design
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on April 4 to discuss high-value approaches and situation-specific considerations for meaningful engagement of internal and external stakeholders in clinical trial design and implementation. Engaging all stakeholders during the earliest stages of study development is an important feature of quality by design (QbD). Aligned with CTTI’s QbD approach, the Engaging Stakeholders in Trial Design Project team is developing an engagement roadmap and recommendations to enable clinical trial designers to meaningfully and effectively engage all stakeholders across the trial design process. The project team is also collating resources surrounding the engagement of stakeholders to increase the efficiency of trial design to benefit patients faster.
Experts from academia, clinical research organizations, patient advocacy groups, regulatory agencies, and the pharmaceutical industry discussed the challenges and opportunities, key strategies, and metrics for assessing holistic stakeholder engagement across the continuum of clinical trials. The following key themes were emphasized during the meeting:
- It is important to engage key stakeholders – including patients, site staff, and regulatory agencies – very early in the design of clinical trials. When planning study timelines, identify all internal and external stakeholders and the appropriate time and approach to solicit their input.
- Stakeholder engagement should be an iterative process throughout the life cycle of clinical trials. Internal and external stakeholders should be engaged, as appropriate, from the beginning of clinical trial design through the dissemination of results.
- Bring stakeholders and functional groups together to identify gaps between teams and brainstorm solutions to increase the quality and efficiency of trials. Effective communication and collaboration across all stakeholder groups is crucial to create a community around designing high-quality studies that meet the needs of patients and that generate reliable evidence with fewer amendments.
- Advanced methodologies and tools, such as artificial intelligence and machine learning, can help study designers develop innovative, high-quality trials and streamline processes. With databases of real-world and clinical trial data, artificial intelligence and machine learning can be used to inform the design of trials, explore potential treatments for patient subgroups, assess feasibility of enrollment, and identify sites.
- A collection of resources for designing clinical trials, including recommendations on how and when to meaningfully engage all stakeholders, is needed to help study designers plan innovative clinical trials more efficiently and in alignment with regulatory guidance.