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Tools for interoperability

Work Package 3 - Research tools to facilitate interoperability in paediatric research

 

GRiP Interoperability in Paediatric Clinical PharmacologyThe lack of standardization across the field of paediatric clinical research is an ever-increasing obstacle to the development and safe use of medicine in children. To combat this hurdle, a series necessary activities which fill facilitate inter-operability has been identified and will be undertaken as part of Work Package 3 of the GRiP project.

 

These activities include:

  • Improving the quality of design, conduct, and reporting of paediatric clinical research by developing and promoting the use of modern research standards.
  • Harmonizing terminology and data standards for drug and vaccine research and medicinal use (including dosages, indication, off-label use in principal therapeutic area).
  • Identifying, developing and harmonizing outcome assessment, endpoints, and biomarkers to evaluate paediatric drug and vaccine responses.
  • Developing systems that will foster harmonization of the technical acquisition of clinical data useable for clinical trials.
  • Standardizing information given to patients and parents in the recruitment process of clinical trials.

LATEST RESULTS

 

Please see the latest results delivered by the GRiP Network under Work Package 3. Where possible, abstracts of the reports have been provided on this page. To obtain more detailed information, you can download the available materials by clicking on the links at the bottom of the page (only public documents will be made available).

 

 

Tool for Data and Safety Monitoring Committees in paediatric randomized clinical trials

 

This tool has been developed to educate practitioners on the role, development and management od Data and Safety Monitoring Committees.

Such committees are a fundamental building block of paediatric clinical trials.  

 

Click here to access the tool - Data and Safety Monitoring Committees in paediatric randomized clinical trials

 

 

• Completed deliverables so far (click on the links to download the reports; where these are not public, a description of the deliverable is available).

 

WP3 – Research Tools To Facilitate Interoperability In Paediatric Research

 

Models for information sharing for Human Research Subject Protection among Ethics Committees and Institutional Review Boards (update)

The deliverable updates and addresses topics not covered in prior submissions. Earlier submissions were based on input from expert panels that confirmed general recommendations published over the past forty years but did not contain new models or empirically generated data. Specifically, the topic of information sharing between ethics committees or Institutional Review Boards is now included describing a detailed innovative model supported by empiric data.

 

Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (4) - final report

In this document it has been presented the methods used to develop a GRiP tool for selecting, measuring and reporting outcomes in paediatric phase II and III clinical trials at the study design and reporting stage. It has also been presented a preliminary checklist developed following systematic evidence gathering, and feedback provided by end-users. The purpose is to assist clinical trialists to systematically select, measure and report outcomes for phase II and III drug trials in paediatric populations.

 

Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (3)

In this document it has been presented the development and evaluation of a tool to be used for containing the risk of bias in paediatric research at the study design, conduct and reporting stage.

 

Reports on harmonised terminology (1-2)

In this document the methods and results for developing harmonised terminology for paediatric research are presented. The purpose is to develop a resource for researchers planning studies involving children to harmonise terminology in implementing protocols, data collection and data analysis. The deliverable aims to contribute to the greater GRiP goal of producing tools to facilitate the general goals of producing quality data and data interoperability for multi-site studies and trials in children, which cross national and regional boundaries.

 

Models for information sharing for human research subject protection among Ethics Committees and Institutional Review Boards (1)

This deliverable analyses the need to streamline the ethical review of multi-jurisdictional paediatric clinical trials. Across jurisdictions, many guidance documents exist to aid in the ethical evaluation of paediatric research. Although built upon several of the same ethical principles, differences in the specific guidance and in the application of this specific guidance exist. This document aims to address the heterogeneous opinions and lack of consistency in the ethical review of multijurisdictional drug trials by focusing on two critical ethics issues for paediatric clinical trials, and collecting and appraising the guidance available on these issues within a group of experts.

 

Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (2)

 

Report on harmonised terminology (3)

 

Report on harmonised outcome assessments, endpoints and biomarkers to evaluate paed. drug response (1)

The aim of this document is to assess current level of evidence supporting the use of outcome measures, endpoints and biomarkers used in efficacy and safety trials in paediatrics.

 

Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (4)

 

Report on harmonised terminology (4)

 

Report on harmonised terminology (5)

 

Report on harmonised outcome assessments, endpoints and biomarkers to evaluate paediatric drug response (2)

This document analyses the need for qualified biomarkers in Sepsis. The objective is to apply a protocol to assess the current level of evidence for the qualification process of sepsis biomarkers used to study efficacy and safety in paediatric clinical trials.

 

Models for information sharing for human research subject protection among Ethics Committees and Institutional Review Boards (2)

This documents give an update on the development of an accessible and pragmatic tool to assist ethics committee members in the evaluation of paediatric clinical trial research. The new tool outlines the critical and specific questions that need answering in the ethics review of paediatric clinical trials and provides guidance to aid in the evaluation of ethics submission materials.

 

Report on harmonised terminology (6)

 

Report on harmonised terminology (7)

 

Report on harmonised terminology (8)

 

An evidence- and consensus-based tool for harmonization of information given to parents and patients in the recruitment process

 

An evidence- and consensus-based tool related to the roles and responsibilities od Data safety and Monitoring Committees in paediatric CTs (2)

This document analyses the development of the GRiP tool for guidance regarding Data and Safety Monitoring Committees (DSMCs) in paediatric research at the study design stage. This tool is a web-based module, addressing principles and practices of Data and Safety Monitoring and is specifically designed for application in paediatric confirmatory (phase III) randomized clinical trials. The aim is to improve the quality of trial design by increasing knowledge, understanding, use and endorsement of the tool.

 

Models for information sharing for human research subject protection among Ethics Committees and Institutional Review Boards (3)

 

Report on harmonised outcome assessments, endpoints and biomarkers to evaluate paediatric drug response (3)

This document represents an advancement on qualified biomarkers in Sepsis. The objective was to assess the role of procalcitonin to differentiate between sepsis and systematic inflammatory response syndromes of non infectious origin in children and neonates, in accordance to the cut-off proposed in the Report on the Expert Meeting on Neonatal and Paediatric Sepsis of European Medicines Agency.

 

Reports on harmonised terminology (9)

 

Report on harmonised outcome assessments, endpoints and biomarkers to evaluate paediatric drug response (4)

The scope of this Report is to request a CHMP advice on the proposed methodology for a Protocol for qualification of procalcitonin for the diagnosis of neonatal sepsis and indication of antibiotic therapy. The scientific rationale for the use of Procalcitonin for the diagnosis of neonatal sepsis is described, with the support of data obtained by the performed systematic review and meta-analysis.  

 

Report on harmonised technical acquisition of clinical data in paediatric research