Mini-course starter kit – Protocol design

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Introduction

This EUPATI Mini-course starter kit is designed for patient involvement in protocol design.

EUPATI Mini-course starter kits have been derived from content found in the EUPATI toolbox and EUPATI Patient Expert Training Course. The starter kits are thought to address roles that patients play in medicines development for example those shown in the figure below.

The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day training on the subject. Each of the starter kits contains a selection of PPT slides which you may use to educate patients/advocates about the “basics” in that area, e.g. in a two-hour to one-day seminar.

The starter kits are based on existing content from the EUPATI Toolbox, plus additional links to add-on Toolbox material. None of the “starter kits” are “ready-made course” modules – they are a ready-to-reuse resource for an experienced trainer to prepare and execute a course. You will need to edit them and put them into context.

Before you begin please download and review the ‘Manual for Trainers’.

Protocol Design

This starter kit provides background reading, slides, a video, and quizzes to create training for patients who intend to become involved in protocol design.

Core reading

Making a medicine. Step 1: Pre-discovery

Making a medicine. Step 2: Target selection

Making a medicine. Step 3 and 4: Choosing a molecule or lead

Making a medicine. Step 5: Non-clinical safety testing

Making a medicine. Step 6: Phase I – Proof of mechanism

Making a medicine. Step 7: Phase II – Proof of concept

Making a medicine. Step 8: Confirmatory studies

Making a medicine. Step 9: Regulatory submission

Making a medicine. Step 10: Life-cycle management

New research areas in personalised medicines

Clinical Trial Designs

Evidence-based medicine

Role of statistics in clinical trials

The concept of blinding in clinical trials

Data collection in clinical trials

Optional

Clinical trials in small populations

Paediatric medicine: Paediatric Investigation Plan

Patient reported outcomes (PROs) assessment

Biomarkers

Basics of Early Clinical Development

Phase I Trials

Phase II Trials

Types of Study in Early Clinical Development

Presentations

Early clinical development (coming soon)

Quizzes

Quizzes will be provided for each presentation in the future on:

Videos

An introduction to clinical research [ECRAN] can be downloaded from EUPATI on Vimeo.

Explore the history of clinical trials stemming back to 1747 and learn more about how they work today in this short video from the ECRAN project.

Clinical Research” by ECRAN Project is licensed under CC BY-NC-SA 4.0

Terms of use - Creative Commons

Remember that all educational content provided by EUPATI is released under a Creative Commons License, which also applies to all derivatives of it! Therefore

  • you must state the license in your course material.
  • you must also release your course material under Creative Commons when using EUPATI material.

Example of how to reference the material if you have not changed anything:
Phases of Clinical Development” by EUPATI is licensed under CC BY-NC-SA 4.0.

Example of how to reference material if you have changed something:
My clinical trials guide” is a derivative of “Phases of Clinical Development” by EUPATI used under CC BY-NC-SA 4.0. “My clinical trials guide” is licensed under CC BY-NC-SA 4.0 by Matthew.

You can read more about the use of EUPATI content on the Creative Commons page of eupati-old.local

Use of the EUPATI logo

The EUPATI logo is protected by trademark and owned by the European Patients Forum.

Except for the limited purpose of indicating that work is created or licensed by EUPATI (European Patients Academy for Therapeutic Innovation), or collaboration with EUPATI, the European Patients Forum (EPF) does not authorise the use, by any party, of the trademark "EUPATI" or any related trademark or logo of EUPATI without the prior written consent of EPF. Any permitted use will be in compliance with EUPATI's then-current trademark usage guidelines, as may be published on its website or otherwise made available upon request from time to time.

A2-SK-protocol-design-V1.0

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