Clinical Development

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EU Compassionate Use Programs

Published by IRDiRC

Clinical DevelopmentRegulatory AffairsResearch and Drug DevelopmentOrphan DrugEarly Access SupportEuropean UnionCompassionate UseEMA Compassionate Use

Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

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National programs for early access

Published by IRDiRC

Regulatory AffairsClinical DevelopmentCompassionate Use

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available

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Decentralized trials 

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentClinical Trial DesignAdaptative PathwayDecentralised TrialPatient DataDigital 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

Research and Drug DevelopmentClinical DevelopmentClinical Trial DesignEndpoint COMETOutcome MeasureEffectiveness Trial

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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Clinical Research Networks

Published by IRDiRC

Cinical Trial DesignRare Disease Clinical Research NetworkClinical Trial ReadinessCRNNIHClinical DevelopmentResearch and Drug Development

The RDCRN is made up of multiple individual, Rare Disease Clinical Research Consortium (RDCRC) and a Data Management and Coordinating Center (DMCC). The RDCRCs are intended to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and Research

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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