Enrolment closes 27th February 2024
Title of Course: Issues Experienced in Adolescent Clinical Trials
Start date of enrolment: 11th Dec 2023
Enrolment closes: 27th Feb 2024 (It is possible to enrol after this date but you will miss the course live webinar scheduled for 28th Feb 2024)
Start date of course: 9th Feb 2024
End date of course: 30th Apr 2024
Course duration: 7-8 hours
To enrol in this course, please contact your National Hub who will supply you with the course password.
Your National Hub’s Referent Person for Training and Education will verify your eligibility to enrol in the Course and provide you with the Course’s enrolment password.
Once you receive this Course’s Enrolment Password from your National Hub, please log in on c4c Academy Platform.
If you don’t have an account yet, click on Create new account and follow the instructions.
General Description
In the last decades significant attention has been paid to the community impact of health disorders in the developmental age, however relatively little focus has been placed on characterizing trends in how the research has responded through specific issues in conducting clinical trials within this population.
Specifically, trial features, such as trial design, targeted disorders, intervention types and trial funders should be better defined to comply with children and adolescent needs. This course will provide a theoretical and practical opportunity to learn how to deal with the most important issues in adolescent clinical trials and how to improve trial design and retention and how to manage difficult situations that may arise during the trial.
Programme:
This course will consist of 7 pre-recorded lectures (approx. 30-40 minutes each in duration) and a live webinar (1 hour) to be held on February 28th 2024). The purpose of the webinar is for learners to interact with the teachers and discuss topics raised in the lectures. Learners are encouraged to watch all pre-recorded lectures in advance of the webinar. There will also be an end of course online quiz which will include 1-2 questions from each of the teachers.
The lectures include:
Introduction on main issues in adolescent clinical trials
Stigma and awareness of illness in the adolescent population
Ethical and legal aspects of clinical trials in the adolescent population (the assent form)
Sex differences in clinical trials
How psychiatric comorbidity can impact on participation to trials
Retention, placebo/nocebo response and maps of risks and possible solutions
The Patient perspective and the critical interaction with parents
Who is the course for?
This course is suitable for Principal Investigators, Sub Investigators, Study coordinators and Research nurses.
**if you are interested into taking part in this course, please contact your country’s National Hub.
Max. number of persons that each national hub can enrol: unrestricted
Bloom’s Taxonomy Level of the Course: 1, 2
Faculty:
Sara Carucci
Marta Balzarini
Marta Ciuffi
Mariana Iskiv
Peter Nagy
Benedetto Vitiello
Begonya Nafria
Maria Cavaller
