Clinical Trial

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ECRIN Services

Published by n/a

Clinical TrialData manangementECRINInsurabce supportMonitoring

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 Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

Published by NIH

Clinical Trial

The purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

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Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases

Published by NIH

Clinical TrialEtiology

NCATS seeks to facilitate rare diseases research by enabling efficient and effective movement toward clinical trials in multiple rare diseases. The purpose of this NOFO is to provide support for basket clinical trials of drugs targeting shared molecular etiologies in more than one rare disease, and in the process to identify and overcome challenges in adapting the oncology basket trial model to rare diseases. Projects proposed for this NOFO will require individuals with expertise in carrying out clinical trials in rare diseases. Applicants are expected to collaborate with clinical investigators at academic institutions. Projects involving clinical investigators who are part of the Rare Disease Clinical Research Network (RDCRN) and which focus on diseases under study in the RDCRN are strongly encouraged. See https://www.rarediseasesnetwork.org/ for additional information.

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ACT-EU is the stakeholder fora and groups within the European medicines regulatory network (EMRN) 

Published by ACT EU

Clinical TrialCTAGNetworkRegulatory

A list of stakeholder fora and groups within the European medicines regulatory network that are involved in the clinical trial lifecycle. Detailed information is published on each group or forum, along with a visual representation of their interactions.

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NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

Published by NIH

Clinical TrialInvestigational Medicinal ProductRare diseases

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

Applicants do not need to be part of the existing NeuroNEXT infrastructure.

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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

Published by NIH

Clinical TrialRare diseasesUnmet Needs

The purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

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Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

Published by EC

Clinical Trialinvestigational medicinal productsMedicinal Products

EU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

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NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)

Published by NIH

Clinical TrialInvestigational Medicinal ProductRare diseases

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS’ strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

Applicants do not need to be part of the existing NeuroNEXT infrastructure.

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