Clinical Trial Design

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Advisory Committee for Therapeutics (ACT) toolkit

Published by UNEW

Clinical DevelopmentTranslational ResearchResearch and Drug DevelopmentTREAT-NMDClinical Trial DesignPreclinical ResearchTemplatesAdvice

The Advisory Committee for Therapeutics (ACT) toolkit provides procedural advice and guidance to replicate the successful TREAT-NMD Advisory Committee for Therapeutics (TACT) model in other rare disease communities. An ACT can provide independent and objective advice to industry and academia, on a real-life therapeutic pathway of drug development programmes. An ACT review can help an applicant to position a candidate compound along a realistic and well-informed pathway to clinical trial and eventual registration. 

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Extrapolation of efficacy and Safety in medicine development

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentClinical Trial DesignTarget PopulationStudy DesignExtrapolation of Efficacy and SafetyAdaptative Pathways

The EMA describes extrapolation as extending information and conclusions available from studies in one or more subgroups of the patient population (source population(s)), or in related conditions or with related medicinal products, in order to make inferences for another subgroup of the population (target population), or condition or product, thus reducing the amount of, or general need for, additional evidence generation (types of studies, design modifications, number of patients required) needed to reach conclusions.

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Decentralized trials 

Published by IRDiRC

Regulatory AffairsResearch and Drug DevelopmentDigital EndpointClinical DevelopmentClinical Trial DesignAdaptative PathwayDecentralised TrialPatient Data

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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