SMIMB1151U Clinical Pharmacology and Biostatistics

Volume 2015/2016
Education

Please note that this is the course description for the study year 2015/16. Information on course dates, prices etc. in coming semesters please visit www.mind.ku.dk

Master's Programme in Industrial Drug Development - compulsory

Compulsory for Master of Industrial Drug Development (MIND) students, elective for other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval). Open for freelance students who meet the admission criteria.

The course is intended for MIND students and other professionals in drug development and health care.

Content

The course covers the transition process of drug candidates from the preclinical stage to clinical evaluation comprising selection of special patient populations, PK/PD methodology, clinical trial designs, and regulatory aspects. Special emphasis will be put on biostatistics including theory, considerations and hands-on calculations for practical use. Further an introduction will be given to in silico trial simulation.

Learning Outcome

The objective of this course is to give participants a thorough understanding of clinical pharmacological considerations during drug development. This will prepare the participants to take active part in the planning and execution of a clinical trial.

Upon completion of the course, participants are expected to be able to:

Knowledge

  • outline comprehensively the clinical pharmacological considerations made during drug development
  • outline comprehensively the transition process from preclinical to man
  • outline basic biostatistical concepts for a clinical trial
  • describe the regulatory requirements for a clinical trial
  • demonstrate knowledge of basic clinical pharmacology as prerequisites for planning a clinical trial
  • demonstrate knowledge of pharmacometrics to optimise trial design


Skills

  • write a protocol on a clinical trial to be valid for the clinic
  • calculate statistics and the power of a clinical study


Competencies

  • plan and critically evaluate a clinical trial
  • handle translational information from the preclinical to the clinical setting
  • identify a special patient population for the trial
  • liaise and communicate professionally using clinical pharmacology and clinical trial terminology
Literature

Chapter 6-9 in Pharmaceutical Medicines ed. J.P Griffin  6th ed. 2010 (100 pages), scientific articles of relevance (16 pages), guidelines (17 pages), notes on biostatistic (15 pages), hand-outs of presentations from lectures ( approximately 135 pages). Total 310 pages.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
It is recommendable to have completed the MIND course Pharmacology before taking this course.
Lectures, tutorials and group discussions.
  • Category
  • Hours
  • Exam
  • 1
  • Lectures
  • 30
  • Preparation
  • 59
  • Project work
  • 30
  • Theory exercises
  • 20
  • Total
  • 140
Credit
5 ECTS
Type of assessment
Written assignment
Written examination, 1 hour under invigilation
Examination design:
1. The written trial protocol. The protocol is written during course to be delivered Thursday the last week. The assessment of the protocol comprises the mode of handling of the posed problem, its solution and the demonstrated level of critical understanding of clinical pharmacology in drug development and the individual presentation. The written trial protocol can be written in groups.
2. Essay and multiple choice exam (1 hour) under invigilation. Each student answers a written exam consisting of short problems and multiple choice questions.
1) and 2) covers 50 % of the final mark, respectively.
Aid
All aids allowed

Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-exam.ku.dk/it_tools/health/ students will at this exam also have access to use a USB stick (for notes etc.)
 

Certain pocket calculators are allowed.

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

13 November 2015. 3-4 pm.

Re-exam

14 December 2015.

Criteria for exam assesment

The purpose of the examination is to test that the examinee has a broad knowledge and comprehension of clinical pharmacology in drug development. To pass the examination the student must be able to:

  • evaluate proof of concept of efficacy and safety in the clinical setting
  • apply biomarkers as surrogate endpoints
  • describe conditions for performing first-in-man studies
  • select groups at risk for at trial
  • establish the correlation between pharmacokinetics and pharmacodynamics of a drug
  • write a simple protocol for a clinical trial according to current regulatory guidelines and GCP
  • calculate basic statistics relevant for measures of clinical effects of drug treatment


The grade 12 is given for an excellent performance displaying a high level of command of all aspects of the relevant material, with no or only a few minor weaknesses.

The grade 7 is given for a good performance displaying good command of the relevant material but also some weaknesses.

The grade 02 is given for a performance meeting only the minimum requirements for acceptance.