Curricula Guides

Uusi opinto-opas (sisältäen myös opetusohjelmat) lukuvuodelle 2018-2019 sijaitsee osoitteessa https://opas.peppi.utu.fi . Tältä sivustolta löytyvät enää vanhat opinto-oppaat ja opetusohjelmat.

The new study guide (incl. teaching schedules) for academic year 2018-2019 can be found at https://studyguide.utu.fi. This site contains only previous years' guides.

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Archived Curricula Guide 2016–2018
Curricula Guide is archieved. Please refer to current Curricula Guides
DRUG0011 Clinical trial design and clinical drug research 5 ECTS
Organised by
Drug Discovery and Development
Person in charge
Petri Vainio and Risto Huupponen

Learning outcomes

The student will be able to describe the phases of clinical drug development and the prerequisites for conducting clinical trials as it comes to legislation, regulation and regulatory guidance. The student will be able to evaluate the ethical issues related with clinical trials. The student will identify the roles of the members of multiprofessional team and those of different interest parties of clinical trials. The student will be able to compile a clinical trial protocol compliant with applicable regulations and guidance and to collect and compose documents needed to initiate and execute a clinical drug trial. The student will be acquainted with statistical approaches employed in clinical trials and with selecting appropriate testing procedures for typical trial designs. The student will be able to evaluate scientific publications based on clinical drug research.

Contents

Phases and types of clinical drug trials, ethical and regulatory evaluation of trials, GCP regulations and legislation regarding clinical drug research, data collection and management in clinical drug trials, composing trial protocols, monitoring and auditing of clinical trials, statistical planning, reporting and interpretation of results, clinical studies for new chemical entities.

After passing the study module, the student should: 1) know how to make a research plan for a clinical drug study 2) know the optimal structure of a clinical drug study and most relevant restrictions and sources of errors in studies 3) know the basic principles of GCP and the central legislation and regulatory guidance for clinical drug research 4) understand the tasks of different professional groups in the efficient and safe implementation of a clinical drug study

Teaching methods

Lectures (30 h), seminars (10 h), practical work (55 h)

Teaching language

English

Modes of study

Lectures, demonstrations of biostatistics, journal clubs, practical work: compilation of a GCP-compliant research plan for a clinical drug trial.

Evaluation

Numeric 0-5.

Recommended year of study

1. year spring

Study materials

Relevant legislation:

Directive 2001/20/EU

Regulation EU No 536/2014

Directive 2005/28/EU

Relevant regulatory guidance:

 

ICH guidelines: E8 General Considerations for Clinical Trials, E3 Structure and Content of Clinical Study Reports and E6 Good Clinical Practice, available on www.turkucrc.fi), other course material

 

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)

 

EMA Guideline on Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products.

Belongs to following study modules

Institute of Biomedicine
2018–2019
Teaching
Archived Teaching Schedule. Please refer to current Teaching Shedule.
Implementation details are unavailable.
Institute of Biomedicine
DP in Biomedicine
Finnish Study Modules
MDP in Drug Discovery and Development
MDP in Biomedical Imaging
Biomedical Imaging