Packages

Work Package 3

Preparation and Monitoring of Clinical Trials Phase I-III

• Involves Partners ZYMX, CUH, CMMC, UMG, IPCZD and HCL

Objectives:
The aim of this WP is to prepare and monitor clinical trials phases I-III, at five different clinical sites within Europe. Preparation of clinical trials includes writing the clinical trial protocol and submission to Authorities and Ethical Committees. The Investigational Medicinal Product Dossier (IMPD) and protocol have to be approved, before the clinical trials can be initiated. Partner 2 is responsible for coordination and implementation of this WP.

Description of the Work:
Preparation (A) and Monitoring (B) of the clinical trials are described below:

• A1) Writing of the clinical trial protocol:
  A clinical trial protocol will be prepared for each of the four trials. The protocol will describe the objectives, design, methodology, statistical considerations and organization of the trial. The protocol will give background and rationale for the trial. If the protocol is changed after approval, a written amendment will describe the changes.
  
  
• A2) Submission of the Clinical Trial Protocol to Authorities and Ethical Committees:
  Before a clinical trial can be initiated, the clinical trial protocol has to be submitted to the Competent Authority and Ethics Committee and has to be approved by these institutions. The process of approval of a clinical trial protocol usually demands 60 days. Ethics Committee must also approve the written patient information/informed consent form.
  
  
• A3) Writing of an Investigational Medicinal Product Dossier (IMPD):
  To perform clinical trials, an Investigational Medicinal Product Dossier (IMPD) is required to accompany an application in any European Member State. The IMPD provides a summary of information on quality of the investigational medicinal product to be used in the clinical trial. It also provides data from non-clinical studies and available previous clinical experience, with the use of the investigational medicinal product. An overall risk-benefit assessment, critically analyzing the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial must also be included. The application and communication must be in the native language of the Ethics Committee. Often the provider of the experimental drug (rhLAMAN) and the Investigator combine forces when submitting an application to Ethics Committee.
  

• B) Monitoring the clinical trials:
  The clinical trials will be carried out according to International Conference on Harmonization (ICH) and the WHO Good Clinical Practice (GCP) standards. GCP is a set of internationally recognized ethical and scientific quality requirements, which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with Good Clinical Practice provides assurance that the rights, safety and well being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.

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