PANDA: A practical Adaptive & Novel Designs and Analysis toolkit

Published by ECRINPANDA

ToolboxClinical Trials Toolkit

PANDA is aimed at trialists and researchers in clinical trials who are keen to learn about adaptive designs, their practical application, potential benefits and limitations. The target audience includes, but is not limited to, trial statisticians, clinicians, health economists, grant proposal developers, trial managers, data managers, and reviewers of grant applications

View this resource Bookmark this resource

The toolkit is a curated series of publicly accessible videos and links covering essential operational details that early investigators need to know before embarking on a clinical trial with a special focus on pediatric trials. Topics address study startup, study documents, consent, oversight, management, and safety.  

View this resource Bookmark this resource

A target product profile (TPP) outlines the desired characteristics of a new drug or other medical intervention (e.g diagnostic tool). TPPs describe intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. In industry TPPs are used as planning tools that guide development towards desired characteristics. In the regulatory context, TPPs are considered as tools to frame development in relation to submission of product dossiers.

View this resource Bookmark this resource

Expert Mentoring Service Information Sheet

Published by EATRIS

Project ManagementEATRISTranslational Medicine support

Advancing promising technologies and therapies towards clinical application is a complex undertaking. Academic research often lacks easy access to regulatory, therapy development expertise, manufacturing, and healthcare practice, leading to high failure rates. For this reason, the European Joint Programme on Rare Diseases (EJP RD) has initiated a mentoring programme for rare disease researchers. The aim of the mentoring is to increase the impact and patient benefit of the excellent science funded in EJP RD. With this mentoring support, applicants will receive project-specific feedback from a panel of drug development, biomarker validation, methodological and regulatory experts tasked with optimizing the translational feasibility of the study.

View this resource Bookmark this resource