Curriculum Development of Human Clinical Trials for the Next Generation Biomedical Students Erasmus Project

Project Title

Curriculum Development of Human Clinical Trials
for the Next Generation Biomedical Students

Project Key Action

This project related with these key action: Cooperation for innovation and the exchange of good practices

Project Action Type

This project related with this action type : Strategic Partnerships for higher education

Project Call Year

This project’s Call Year is 2018

Project Topics

This project is related with these Project Topics: Health and wellbeing; International cooperation, international relations, development cooperation; ICT – new technologies – digital competences

Project Summary

At the start of the application, the consortium was made up of 5 higher education institutions, coordinated by UP.
During the project one higher education institution was replaced by University College Cork instead of MMI Clinical Research Development Ireland due to a change of expertise. ECRIN has been a supporting partner throughout.
The main aim of the project was to tackle the skills gaps and mismatches in European Clinical Trial Professionals through curriculum development and preparation of e-learning materials for biomedical (medical, pharmacy, clinical research master) students. The planned curriculum on clinical trials was develped and produced as e-learning materials, as originally intended. The curriculum meets the needs of biomedical students wishing to puruse a career in clinical trials.This could be in any of the areas related to clinical trials; data management, quality management, research nurse, methodology, trial conduct, study monitor, trial manager etc.
All objectives of the project were met and the planned outputs were delivered. Unfortunately we didn’t manage to organize all the face-to-face meeting except the first one due to COVID-19. These were pivoted to online (TPMs are attached). The same was true of the multiplier events. All MEs were held online (attached). We had a plan to organize one ME in person in each of the participating countries. We waited as long as possible in the hopes we woud implement these events but because of COVID we didn’t succeed.

The following original project outcomes were completed within the project timeline.
1. Syllabii developed (14 topics) – IO1
Our proposal divided this into Module 1 (Basic learning material/syllabi) and Module 2 (Bioinformatics). After discussion with the partners, and review by ECRIN partners, there was overlap between the two syllabi and it was decided that the optimum presentation for learning flow was to present both syllabii together as 14 individual lessons. In this way, the material flowed naturally.

Lesson 1: History of Clinical Trials
Historical development of clinical trials; Book of Daniel, James Lind, introduction of double blind, randomisation, allocation concealment.

Lesson 2: Why trials?
Hierarchy of evidence; consideration of the unique elements of a randomised controlled trial that make it the gold standard for clinical studies; The landmark 1946 streptomycin trial

Lesson 3: Trials we have learned from
Walter Reed’s Yellow Fever Study; Nazi Medical Experiments; The Imperial Japanese experiments in China

Lesson 4: Case study: Tuskegee Syphilis
In depth consideration of the ethical issues surrounding the Tuskegee Syphilis Trial and the long-lasting implications for research

Lesson 5: Ethics in Clinical Trials
Ethical advances in human protection, milestones including Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Conference on Harmonization Good Clinical Practice guidance. Example, the hepatitis experiments

Lesson 6: Equipoise; Forming a research question
The place of non-interventional studies; systematic reviews; Equipoise definition; FINER criteria;

Lesson 7: Clinical Trial Phases
Detailed description of Phase I to Phase IV

Lesson 8: Phase 3 trial design
In depth consideration of Phase III trials. Concepts of randomisation, control group, blinding

Lesson 9: Phase 3 trial design
Continuation of above ; allocation concealment ; inclusion criteria ; exclusion criteria

Lesson 10: The numbers…sample size, why it’s important
Sample size ; Per protocol analysis versus ITT analysis ; The Salk Polio Vaccine

Lesson 11: What patients should know _ informed consent
The ethics of consent and informed consent ; assent ;

Lesson 12: Clinical trials in special populations
What’s the same and what’s different about clinical trials in special populations

Lesson 13: The clinical trial protocol
Step by step guidance on writing a clinical trial protocol

Lesson 14: Form your own research question and design your own trial
Practical session ; designing your own phase III trial from your research question

2. E-learning materials developed – IO2

Once the 14 lessons were prepared, they were forwarded to the Universite de Nova de Lisboa partners, who with the cooperation of the University of Pècs, designed and managed the e-learning platform for CONSCIOUS. All lessons were added to the web portal using instructional design experience to form the e-learning materials and allow users to self-register for the course and study clinical trials any place and any time. This included reading materials, video clips, recordings of trialists, and development of grapical content as needed. Link: http://conscious.novaims.unl.pt/login/index.php

3. ICT platform developed (http://conscious.novaims.unl.pt/login/index.php) to support the syllabus (IO1) and e-learning materials (IO2) developed.
In order to suppor IO1 and IO2 syllabii and materials, we needed a means of makign the curiuculum available worldwide. We did this via a learning management system (LMS), Moodle. The LMS platform is the most important dissemination interface of the curriculum. Our dedicated web portal provides access to the LMS. The web portal contains all the information on CONSCIOUS and is open access. This consists of the undergraduate curriculum in clinical trials and bioinformatics, IO1 and IO2. In addition the teachers guides (IO3) are also availabel here. The LMS platform set up is based on a framework widely used by international higher education institutions. It provides a unique login for teachers and students, allowing roles to be assigned with different permissions during use.The LMS platform enables uploading of traditional but digitised curricula – notes, textbooks, etc. It also enables the direct integration of their content with the appropriate fields on the platform – this is particularly important for accessibility. In addition to traditional forms of learning, the framework enables collaborative, experimental learning to facilitate online communication between teachers and students (forum, chat). The system also has a number of other learning-support functions: tasks can be issued and recalled; surveys and tests can be created; assignments can be assigned and corrected; online presence can be measured. Using all of these features, they can be easily tracked and logged. Classifying students’ work is also possible.

4. Teacher’s guides developed (1 x 14 lessons) – IO3
The main result was the creation of structured teacher’s guides for each of the 14 lessons in IO1. The Teacher’s guides closely follow e-learning content (summarise the professional and methodological content) and, in each section, offer instructions on:
1. organisation of the lesson according to the target audience;
2. organisation of lessons with different scope and methods of using e-learning;
3. implementation of critical thinking methods;
4. activation of students;
5. lesson timing/schedule.

Teacher’s manuals also contain solutions to practical activities – a partial and comprehensive approach. Using the teacher’s guide, the lecturer with any type of biomedical training will be able to teach a lesson in the planned range of 90-150 minutes without being involved in the preparation of the materials. Teacher’s manuals precisely define learning outcomes and acquired knowledge, skills and competencies. Each teacher’s guide, therefore, serves as a basis for the implementation of the lesson by the lecturer. A general template of the Teacher’s guide was prepared by MU to ensure uniformity. Each partner contributed the content for the teachers guide relevant to the lesson they designed in IO1.

CONSCIOUS provides (and we use the present tense here because this project will extend beyond the life of the funding) training on the design, conduct and implementation of clinical trials to faciliate the conduct of efficient clinical trials and improve the life and health of all those in society who could benefit. This is especially important in trials as many are multicentre and multinational. It will equip students with the confidence and skills to change the way trials (and other research) are designed in the future. For those who may never design a trial themselves, the impact will be to help them use trial results more appropriately, including as patients. We expect this impact to be spread across partners [but especially some e.g. those who know they can embed the training now.

Project Website

http://conscious.novaims.unl.pt/login/index.php

EU Grant (Eur)

Funding of the project from EU: 248048,79 Eur

Project Coordinator

PECSI TUDOMANYEGYETEM – UNIVERSITY OF PECS & Country: HU

Project Partners

• UNIVERSIDADE NOVA DE LISBOA
• UNIVERSITE PARIS DIDEROT – PARIS 7
• Masarykova univerzita
• MMI CLINICAL RESEARCH DEVELOPMENT IRELAND
• UNIVERSITY COLLEGE CORK – NATIONAL UNIVERSITY OF IRELAND, CORK