Research and Drug Development

The information and resources in this section can help you navigate in the Research and Drug Development area to identify issues classified for:
Disease models,
Disease/Translational resources,
Drug Discovery,
Clinical Development,

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  2. Research and Drug Development
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Feasibility-Patient engagement in trial endpoint selection 

Published by IRDiRC

Research and Drug DevelopmentClinical DevelopmentEndpointPatient EngagementClinical TrialOutcome MeasureTrail Endpoint Selection

Guidance on the pivotal clinical trials outcomes measures .The important of the patient’s feedback. Academics can then assess whether there is an outcome measure available that can measure this – if not, outcome measure(s) may need to be developed.

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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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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Regulatory AffairsClinical DevelopmentClinical Trial DesignRegulatory AdviceSpecial Protocol Assessment

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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ECRIN Clinical research metadata repository

Published by ECRIN

ECRINClinical Research metadata repository

The Clinical Research Metadata Repository is the online tool to help scientific researchers find documents and data linked to a clinical research study, and to obtain information on the accessibility of those results. ECRIN made the Clinical Research Metadata Repository freely available for all scientific researchers, and is updated regularly through collection of data from the most important sources of information worldwide, from New Zealand to The Netherlands and from Japan to Lebanon.

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the Biomedical Data Translator

Published by NCATS

NCATSDatabase

NCATS launched the Biomedical Data Translator (Translator) program to accelerate biomedical translation for the research community. Through this program, NCATS will integrate multiple types of existing data sources and reveal potential relationships across the spectrum of data types.

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