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AdviceClinical DevelopmentClinical Trial DesignPreclinical ResearchResearch and Drug DevelopmentTranslational ResearchTREAT-NMDThis agenda template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.
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AdviceClinical DevelopmentClinical Trial DesignPreclinical ResearchResearch and Drug DevelopmentTranslational ResearchTREAT-NMDThis applicant agreement template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.
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AdviceClinical DevelopmentClinical Trial DesignPreclinical ResearchResearch and Drug DevelopmentTranslational ResearchTREAT-NMDThis conflict of interest form template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.
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AdviceClinical DevelopmentClinical Trial DesignPreclinical ResearchResearch and Drug DevelopmentTranslational ResearchTREAT-NMDThis pre-application form template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.
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AdviceClinical DevelopmentClinical Trial DesignPreclinical ResearchResearch and Drug DevelopmentTranslational ResearchTREAT-NMDThis report to the applicant template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.
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Clinical DevelopmentClinical Trial DesignGuidelineRegulatory AdviceRegulatory AffairsThe European Medicines Agency’s Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
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Adaptative PathwaysClinical DevelopmentClinical Trial DesignExtrapolation of Efficacy and SafetyRegulatory SciencesResearch and Drug DevelopmentStudy DesignTarget PopulationThe 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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Adaptative PathwaysClinical DevelopmentClinical TrialClinical Trial DesignRare DiseaseRegulatory SciencesSmall PopulationGuidance 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.
View this resource Bookmark this resourceDecentralized 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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