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Pharmaceutical Outcome Research – Scientific key in the Life Cycle of Pharmaceutical Interventions

Vak
2022-2023

Admission requirements

Master students of Bio-Pharmaceutical Sciences, Biomedical Sciences, Life Science & Technology, Molecular Science & Technology, Mathematics/Statistics.

Description

Late-stage clinical outcome of pharmaceutical interventions plays a key role in the drug life-cycle. Besides its pivotal role in regulatory milestones, it also bridges discovery and early (pre-) clinical stages to post-approval/market access and real-world stages of this life cycle. With several thousands of clinical trials conducted, and made publicly available each year, late-stage clinical outcome also poses an enormous data challenge, both in terms of data identification, -extraction, analysis. During this class the concepts of clinical trial design- and conduct, systematic literature review, statistical meta-analysis, as well as other data science aspects will be addressed. Furthermore, integration of late-stage clinical outcome into end-to-end (bench-to-bed) predictive modelling strategies will be addressed on the basis of specific case-studies and hands-on exercises.

This course aims to:

  • Raise students’ interest and enthusiasm for clinical trials, systematic literature review, meta-analysis and drug-life cycle management.

  • Give an introduction of the most important concepts, value proposition and analytical methods used and their application in pharmaceutical outcomes research.

  • Give the student sufficient background to conduct and interpret systematic literature review of pharmaceutical outcome research.

  • Introduce a number of data science elements on data identification, -curation, -analysis and -visualization that are relevant for pharmaceutical outcome research.

  • Provide an opportunity for students to get hands-on exposure to pharmaceutical outcomes research.

Note that these are expert lectures series and that hence the content might change every year.

Course objectives

At the end of this course the student is able to:

  • Understand the basic concepts of pharmaceutical outcomes research and its position in drug life-cycle management.

  • understand key features of clinical trials as the basis for pharmaceutical outcomes research such as design, conduct, analysis and reporting.

  • Appreciate key data science elements in pharmaceutical outcomes research such as data identification, curation, organization, visualization and analysis and value communication.

  • Understand essential data analytical features in meta-analysis, such as variability between/within trials, explanatory variables, publication bias, weighing, missing data, etc.

  • Conduct a basic systematic literature review, including meta-analysis and reporting/communication.

  • Effectively use data visualization software.

  • Present a scientific research paper to peers.

Timetable

You will find the timetables for all courses and degree programmes of Leiden University in the tool MyTimetable (login). Any teaching activities that you have sucessfully registered for in MyStudyMap will automatically be displayed in MyTimeTable. Any timetables that you add manually, will be saved and automatically displayed the next time you sign in.

MyTimetable allows you to integrate your timetable with your calendar apps such as Outlook, Google Calendar, Apple Calendar and other calendar apps on your smartphone. Any timetable changes will be automatically synced with your calendar. If you wish, you can also receive an email notification of the change. You can turn notifications on in ‘Settings’ (after login).

For more information, watch the video or go the the 'help-page' in MyTimetable. Please note: Joint Degree students Leiden/Delft have to merge their two different timetables into one. This video explains how to do this.

Mode of instruction

Lectures (hoorcolleges).
Tutorial (werkcollege).
Tutoring (studiebegeleiding).
Self-tuition (zelfstudie).

Assessment method

The student’s capacity will be assessed in two ways:

  • An exam (open questions, 50%).

  • A scientific communication describing a systematic literature review (paper, or an interactive app, 50%).

The final grade should be 6.0 to successfully complete this course.

Reading list

A reading list will be announced during the course.

Registration

From the academic year 2022-2023 on every student has to register for courses with the new enrollment tool MyStudyMap. There are two registration periods per year: registration for the fall semester opens in July and registration for the spring semester opens in December. Please see this page for more information.

Please note that it is compulsory to both preregister and confirm your participation for every exam and retake. Not being registered for a course means that you are not allowed to participate in the final exam of the course. Confirming your exam participation is possible until ten days before the exam.

Extensive FAQ's on MyStudymap can be found here.

Contact

Coordinator: Prof. dr. Elizabeth (Liesbeth) de Lange (ecmdelange@lacdr.leidenuniv.nl, tel 071-5276330).

Remarks

This information is without prejudice. Alterations can be made.