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Alternative designs for Small Population Clinical Trials

Published by IRDiRC

Small Population Rare Disease Clinical Trial Clinical Trial Design Clinical Development Regulatory Affairs Adaptative Pathways

Guidance and general recommendations are available to select the most efficient study design for each medical condition or trial, and on potential adaptions of conventional designs to the low sample size scenario.

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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Special Protocol Assessment Regulatory Affairs Clinical Development Clinical Trial Design Regulatory Advice

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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Decentralized trials

Published by IRDiRC

Research and Drug Development Regulatory Affairs Clinical Development Clinical Trial Design Adaptative Pathway Decentralised Trial Patient Data Digital Endpoint

Decentralized trials aim to improve patient access to trials by enabling patient follow-up from home or community care, increase the participation of more diverse populations, and enhancing data collection by combining the adoption of digital endpoints and telemedicine as applied to trials, decentralized trials aim

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Core Outcome Measures in Effectiveness Trials

Published by IRDiRC

Clinical Development Effectiveness Trial Outcome Measure Endpoint COMET Clinical Trial Design Research and Drug Development

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials.

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