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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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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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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ECRIN Services

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Multinational clinical trialECRIN

When planning a multinational clinical trial, you need to consider financial, scientific, regulatory and administrative aspects long before you recruit the first patient. It is necessary to access experts and patients at other sites and countries, but complying with local regulations and requirements, sourcing services, and identifying collaborators can be a challenge. ECRIN is here to guide investigators/sponsors, project coordinators and other stakeholders through the different facets of multinational trial organisation.

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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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