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

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 Conducting Survey on Registering and Reporting Clinical Trial Information on ClinicalTrials.gov

The ClinicalTrials.gov Reporting Challenges Project is conducting a survey following in-depth interviews that were conducted in late 2021. We invite individuals who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey. You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.  

Additional information for potential survey participants is provided below. 

What are you being invited to do?  

CTTI is conducting a survey to learn more about organizations’ experiences with registering and reporting clinical trial information on ClinicalTrials.gov. 

We invite individuals at organizations such as academic institutions, medical product companies, government agencies, and non-government organizations who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey.  

The survey focuses on policies and approaches your organization implements to comply with ClinicalTrials.gov regulatory requirements, as well as the advantages and disadvantages of your approaches, challenges faced, and suggested strategies for addressing challenges. 

How will CTTI use the information? 

CTTI will outline useful practices for improving the reporting of timely, accurate, and complete registration and results information on ClinicalTrials.gov.  

Your name and organization will not be included when CTTI reports the survey findings. CTTI will send the FDA an aggregated summary of survey findings to inform their approach to supporting more complete reporting of clinical trial information. 

Interested in participating? 

If you provide oversight, register, and/or report clinical trial information on ClinicalTrials.gov, please click on this link to take the survey.

You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov. 

Have questions? 

For questions about this survey, please email CTTI Project Manager Kelly Franzetti.

New CTTI Project Aims to Engage All Stakeholders in Clinical Trial Design

Engaging patients and all stakeholders from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials. Yet important gaps remain, including a lack of comprehensive resources for engaging all stakeholders and a unifying framework, especially one tied to regulatory guidance.

To address these gaps, CTTI is starting work on a new project that will result in an engagement roadmap, multi-stakeholder recommendations, and supporting resources for effectively and efficiently engaging all stakeholders in the design of clinical trials. This project aims to identify:

  • Specific opportunities and high-value approaches/methods/tools for study designers to engage with internal and external stakeholders across the clinical trial design and planning process.
  • Situation-specific considerations for ensuring engagement is appropriately equitable, effective, and feasible.

In carrying out this work, CTTI will conduct iterative design and evidence gathering activities, including a landscape scan, user-testing and formal research aimed at reaching consensus across stakeholders on suggested engagement, and one or more multi-stakeholder expert meetings to review and synthesize findings.

By taking a multifaceted approach, CTTI will create resources that will enable clinical trial designers to collectively and coherently use various existing methods to engage all stakeholders across the trial design process – leading to more efficient, higher quality research in alignment with CTTI’s vision for clinical trials by 2030.

Collaborative Engagement in Clinical Trial Design

Topics Included: Ensuring Quality, Patient Engagement

Engaging all collaborative partners from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials. CTTI’s project, Collaborative Engagement in Clinical Trial Design, will create an engagement roadmap with supporting resources that will enable clinical trial designers to efficiently and effectively engage all partners across the trial design process, in alignment with CTTI’s vision for clinical trials by 2030.

Resources

Access to Clinical Trials | CTTI News

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

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...

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Enhancing Diversity and Inclusion in Clinical Trials

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may...

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CTTI Conducting Survey on Registering and Reporting Clinical Trial Information on ClinicalTrials.gov

The ClinicalTrials.gov Reporting Challenges Project is conducting a survey following in-depth interviews that were conducted in late 2021. We invite individuals who provide oversight, register, and/or report trial results information on...

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New CTTI Project Aims to Engage All Stakeholders in Clinical Trial Design

Engaging patients and all stakeholders from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials. Yet important gaps remain, including...

Patient Engagement

Collaborative Engagement in Clinical Trial Design

Engaging the broad range of stakeholders from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials.

Formats

Stage of Trial