Clinical Trials Transformation Inititative (CTTI) Tools

The Clinical Trials Transformation Initiative (CTTI) runs practical projects to fix real problems in how clinical trials are designed, run and reported. These projects bring together regulators, sponsors, sites, patients and other experts to define a problem, collect evidence and publish concrete recommendations and tools that others can reuse. The goal is to make clinical trials higher quality, faster and more patient‑centred, aligned with CTTI’s Transforming Trials 2030 vision. CTTI's projects page lists over 30 active and completed initiatives grouped into thematic categories. Each project typically yields publicly available recommendations, tools or guidance documents. These projects cover practical operational challenges common in academic trials, and their freely available tools and recommendations can be applied regardless of sponsor type. Projects are browsable by category on the CTTI website; each project links to its own page with outputs, publications and downloadable tools.

Instead of a long catalogue of project names, this page groups CTTI projects by the kinds of challenges trial teams face. That way, sponsors, CROs, investigators and sites can quickly find the resources that match their needs.

• Ensuring quality
  Use these projects when planning or refining a protocol and wanting to build in quality from the start.
  Projects: Quality by Design, Informing ICH E6 Renovation, Collaborative Engagement in Clinical Trial Design, Antibiotic Drug Development
• Innovative trials
  Use these projects when exploring new trial designs, digital health technologies or decentralised and hybrid approaches.
  Projects: Master Protocol Studies (multi‑arm or multi‑cohort trials run under a single overarching protocol), Developing Novel Endpoints (including those derived from digital health technologies), Optimising Data Quality and Flexibility in Clinical Trials, Digital Health Trials, Electronic Healthcare Data, Embedding Clinical Trials into Clinical Practice, Interacting With Regulators, Large Simple Trials (streamlined trials with simplified procedures and large sample sizes), Managing Data, Planning Decentralised Trials, Selecting and Testing a Digital Health Technology, Supporting Sites, Using Disease Progression Modelling to Advance Trial Design and Decision Making
• Site planning
  Use these projects when assessing and strengthening site readiness or preparing networks for study start‑up.
  Projects: Study Start‑Up, Investigator Community, Investigator Qualification
• Recruitment
  Use these projects when the main challenge is identifying, informing and enrolling participants.
  Projects: Informed Consent, Real‑World Data
• Regulatory submissions & approvals
  Use these projects when planning for trial registration and results reporting.
  Projects: Challenges Meeting US ClinicalTrials.gov Reporting Requirements
• Access to clinical trials
  Use these projects when aiming to improve inclusion, diversity and proportionate enrolment.
  Projects: Diversity in Clinical Trials, Collective Strategies to Enhance Proportionate Enrolment
• Patient engagement
  Use these projects when involving patients and patient groups as partners in trial design and conduct.
  Projects: Patient Group Engagement, Patient Engagement Collaborative
• Clinical trials landscape
  Use these projects when seeking insight into overall trial activity, capacity and transformation.
  Projects: Watchtower, State of Clinical Trials, Measuring Trials Transformation
• Safety
  Use these projects when focusing on participant safety, oversight structures and safety reporting.
  Projects: Single IRBs for multicentre clinical trials (supporting a single research ethics committee for multi‑site studies), Safety Reporting, Pregnancy Testing, Data Monitoring Committees (independent expert groups overseeing accumulating safety and efficacy data)
• Data collection and reporting
  Use these projects when planning how digital and other data will be captured, managed and reported.
  Projects: Original Digital Health Trial Projects
• Decentralised and hybrid trials
  Use these projects when shifting from traditional site‑centred models to decentralised or hybrid designs.
  Projects: Planning Decentralised Trials, Optimising Data Quality and Flexibility in Clinical Trials
  Example: a CRO designing a hybrid heart‑failure study can use Planning Decentralised Trials for model and logistics choices, and Selecting and Testing a Digital Health Technology to choos+K57e and validate wearables and apps.

How to use this page
Researchers can start by identifying their main challenge (for example, “We lack diverse enrolment”, “Our digital trial is too complex” or “We are stuck at study start‑up”). They can then select the project area that matches their needs to access targeted recommendations, tools and examples.