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. 

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.