Clinical Trial

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Stakeholders interactions – Professional affairs and Community Engagement

Published by IRDiRC

Regulatory AffairsEarly Access SupportPatient AdviceClinical TrialScientific AdviceRegulatory AdviceEarly Stage InteractionProfessional AffairsCommunity Engagement

Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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Procedural document: data collection and registration of clinical trials

Published by Orphanet

Patient EngagementClinical TrialOrphanet

Orphanet offers, amongst a range of expert resources on rare diseases, a directory of national and multinational clinical trials aiming to help: – clinical investigators working in the field of rare diseases find each other, establish collaborations, recruit patients; – patients and general public retrieve information on ongoing clinical trials for a particular disease, and stay informed on clinical trials that are recruiting; – experts, funding agencies and pharmaceutical industry obtain visibility on therapeutic development in the field of rare disease.

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Advisory Committee for Therapeutics (ACT) Toolkit

Published by Newcastle University

Research and Translational ResourceNetworkExpert AdviceClinical TrialNeuromuscular

The TREAT-NMD Advisory Committee for Therapeutics (TACT) is a unique multi-disciplinary model centred upon an international group of academic and industry drug development experts, including patient representatives. TACT gives advice on the translational and development pathway of therapeutic programs in rare Neuromuscular Diseases. Due to its success in the neuromuscular field, a toolkit to replicate the TACT model has been produced. The Advisory Committee for Therapeutics (ACT) toolkit is intended to support rare disease communities outside of Neuromuscular to establish their own ACT, by providing them with step-by-step guidance and template documentation.

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Exploring the new horizons of Drug Repurposing: A vital tool for turning hard work into smart work

Published by European Journal of Medicinal Chemistry

Research and Drug DevelopmentClinical TrialDrug DiscoveryDrug RepurposingLead Molecule

This review provides different approaches for Drug Repurposing and addresses recent developments and future scope of drug repositioning strategies. In addition provides a list of repurposed drugs and repurposing resources.

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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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ECRIN Services

Published by n/a

Clinical TrialECRINInsurabce supportData manangementMonitoring

During project implementation, ECRIN offers investigators and project coordinators various trial management services, accompanying them all the way from recruitment of the first patient to scientific publication. ECRIN services include:

Submissions to competent authorities & ethics committees: ECRIN can manage submissions to regulatory and ethics authorities in participating countries, ensuring that timelines are respected to avoid delays
Insurance support: ECRIN can provide information regarding multinational trial insurance OR ECRIN can provide quotations for local insurance for multinational clinical trials
Monitoring: All tasks related to monitoring such as training, on-site visits and reporting can be handled by ECRIN across country sites
Adverse event reporting: ECRIN can support local reporting according to national requirements
Data management: ECRIN-Certified Data Centres may be used for data management in multinational trials (learn more about Data Centre Certification) 
Recommendations for health product and biosample management: ECRIN can provide contacts for medicine and sample handling across countries

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Clinical trials – Regulation EU No 536/2014

Published by EMA

Clinical TrialRegulation

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements

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