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  6. C3TI Compass (Knowledge Repository) | Glossary
  1. CDER Center for Clinical Trial Innovation (C3TI)

C3TI Compass (Knowledge Repository) | Glossary

CDER Center for Clinical Trial Innovation (C3TI)

A glossary of terms for C3TI's Compass Knowledge Repository.

Area of research: specific domain or subject of innovation

  • Adaptive Trial Design: Flexible trial methodologies allowing modifications based on early results. 
  • Artificial Intelligence and Machine Learning (AI/ML): A branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. 
  • Bayesian: Enhancements in clinical trial analysis using Bayesian statistical methods. 
  • Complex Innovative Designs (CID) Adaptive Designs: Advanced methodologies that adjust the trial's protocol based on ongoing results, optimizing efficiency and outcome relevance. 
  • Complex Innovative Designs (CID) Bayes Analytical Methods: The application of Bayesian statistics to update trial outcomes dynamically, incorporating prior knowledge and real-time data for more informed decision-making. 
  • Complex Innovative Designs (CID) External Controls: Using control data from external sources, such as historical data or real-world evidence, for comparative analysis in situations where traditional control groups are not feasible. 
  • Complex Innovative Designs (CID) Master Protocols: Single structured protocols for simultaneously conducting various sub-studies, enhancing the flexibility and efficiency in exploring multiple therapies or diseases. 
  • Data Standards: A set of rules on how a particular type of data should be structured, defined, formatted, or exchanged between computer systems. 
  • Decentralized Clinical Trials (DCT): A clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites. 
  • Digital Health Technology (DHT): A system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. 
  • Endpoint: Development of new outcome measures for assessing treatment effectiveness. 
  • Master Protocols: Streamlined approach for conducting multiple clinical trials under a unified protocol. 
  • Patient Engagement: Enhanced involvement of patients in the clinical trial process. 
  • Real-World Data/Real-World Evidence (RWD/RWE): Use of real-world clinical data to shape trial designs. 
  • Trial Design: Integration of new methods and technologies in clinical trial planning. 

Form: innovative type 

  • Collaborations: Joint efforts and partnerships between the FDA and external entities to achieve shared goals in healthcare and regulation. 
  • Case Studies: Detailed analyses of specific instances or situations to illustrate regulatory processes, decisions, or healthcare outcomes. 
  • Guidance Documents: Official FDA publications offering directions or recommendations on regulatory policies and practices. 
  • Programs: Initiatives or schemes designed to support and enhance regulatory processes and healthcare advancements. 
  • Trainings: Educational programs and resources provided to enhance understanding and compliance with FDA regulations and standards. 
  • Tools: Resources or applications designed to assist in regulatory compliance, data analysis, or process management in healthcare and pharmaceutical sectors. 

Development phase: drug development stage

  • P1 (Safety): Focuses on assessing the safety and tolerability of a drug in a small group of healthy volunteers or patients. 
  • P2 (Dose-Ranging): Aims to establish the optimal dose of a drug by evaluating its efficacy and side effects in a larger group. 
  • P3 (Pivotal): Focuses on large-scale testing to confirm the drug's efficacy, monitor side effects, and collect information for drug labeling. 
  • P4 (Post-Market): Involves ongoing studies after a drug is approved and marketed to gather additional information about its effectiveness and safety. 
  • Phase-Agnostic: Not specifically tied to phase of development or generally applicable.  
  • Retrospective, Non-Interventional, Observational: Studies that analyze existing data or observe participants without altering their current treatment or condition.

Source/ownership: party or organization that led the creation of the innovation asset

  • Academia: Educational and research institutions that contribute to the scientific foundation and advancement of medical knowledge, often collaborating with the FDA and industry. 
  • Collaboration: Joint efforts among various entities, such as the FDA, industry, and academia, to achieve common goals in healthcare and drug development.  
  • FDA (Food and Drug Administration): A federal agency of the United States Department of Health and Human Services, responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. 
  • Industry: Refers to the commercial sector involved in the manufacturing, development, and marketing of drugs, medical devices, and other health-related products. 

Privacy/shareability: disposition of the innovation asset’s information security

  • Non-Public Content: Content that is not available to the general public, often restricted due to privacy, confidentiality, or security concerns, and typically requires authorization or specific conditions to access or share. 
  • Public Content: Information or data that is openly accessible to the general public, often available on the internet or through public records, without any restrictions on sharing or distribution. 

Return to C3TI's Compass Knowledge Repository

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