Planning and Evaluation of Trial Protocols

Author: Julia Hannemann, Irene Krämer, erstellt 2003/07/26, Editor: Dr. med. Ralf Herold, Last modification: 2009/06/23

Trial centers of therapy optimization trials led by the German Society for Pediatric Oncology and Hematology (GPOH) regularly create new trial protocols and design new case report forms. Since 2001 the Study Support Group offers its services to support the trial centers.

As part of this service, relevant documents are provided already in the planning phase of a trial. Aditionally, protocols and case report forms are checked for accordance with GCP (Good Clinical Practice), congruence of statements, formal aspects, and potentials for standardization. Unification and improvement of the protocols usability are the main objectives of this process. The resulting recommendations and suggestions are directed to the trial centers in written form.

It is advised to implement the Study Support Group's recommendations - if possible - before an evaluation by the German Cancer Society's Committee on Clinical Trials ('Leitkommission Klinische Studien') takes place. This can help to reduce the reviewer's requests for changes.

The Study Support Group uses the Committee's GCP reports as a basis for issuing further suggestions on the creation of trial protocols.

Tools for trial preparation and realization:

Trial master file

In March 2003 an exemplary Trial Master File was introduced and distributed to the trial centers. It allows to collect all relevant documents in a single file (protocol, amendments, all enquiry form versions, contracts, etc.).

Trial master file

In March 2003 an exemplary Trial Master File was introduced and distributed to the trial centers. It allows to collect all relevant documents in a single file (protocol, amendments, all enquiry form versions, contracts, etc.).

Table of contents for GPOH trial protocols

As a tool for protocol creation, the Working Committee 'Quality Assurance for GPOH Clinical Trial Centers' designed a standardized Table of Contents. It is thought to serve as a template for future trial protocols. The present version is to be regarded as preliminary as it lacks the approval of the GPOH management.

GPOH Table of Contents (138KB)
Author: Julia Hannemann, Irene Krämer
Table of Contents for GPOH Trial Protocols (restricted access)

Modified GCP checklist

The German Cancer Society issued a checklist for the GCP criteria evaluation of protocols that has been modified to suit the demands of GPOH therapy optimization trials. Table of contents and checklist are the basis for the creation of an independent master protocol for pediatric oncology (for further information see Quality Assurance).

Assessment of Toxicity

Some of the National Cancer Institute's third version Common Toxicity Criteria (CTC) have been translated into German by the GPOH Standardization Committee and included in the Common Data Set. These German scales were used to design an exemplary form for toxicity assessment (see Toxicity Form).

Collection of information on Good Clinical Practice (GCP)

A collection of links concerning GCP helps to keep up to date on guidelines, publications, and sources of information relevant for protocol creation.

Collection of information on Good Clinical Practice (GCP)

A collection of links concerning GCP helps to keep up to date on guidelines, publications, and sources of information relevant for protocol creation.




 
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