Clinical Pharmacology and Biostatistics

Klinisk farmakologi og biostatistik
Course code: FMIMB1151U (previously B-8115)

Course objectives

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.

Target group

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

Prerequisites

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.

Expected learning outcomes

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.

Contents

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.

Syllabus

Chapter 6-9 in Pharmaceutical Medicines ed. J.P Griffin & J.O. Gray 5th ed. 2008 (127 pages), scientific articles of relevance (16 pages), guidelines (17 pages), notes on biostatistic (15 pages), hand-outs of presentations from lectures (135 pages). Total 310 pages.

Teaching methods

Lectures, tutorials and group discussions.

Examination and assessment

Type of examination: A combination of class performance, written report and oral presentation.

Examination design:

1. The student’s performance in class (20 %).
2. A written protocol (50 %). The assessment of the protocol comprises the individual mode of handling of the posed problem, its solution and the demonstrated level of critical understanding of clinical pharmacology and biostatistics in drug development.
3. An oral presentation of the protocol and a short oral examination (30%). The oral presentation is conducted in groups of approximately 7 students. Each student gives an individual oral presentation of a part of the protocol from the group

The participants are subsequently questioned individually with a minimum of 5     questions. If a student cannot answer a question correctly, another student in the group is given the opportunity to answer the question. The assessment comprises the quality of the presentation and the proficiency demonstrated by the student during the short oral examination.

Assessment: According to the 7-point grading scale

Examiner(s): Part 1 is assessed by the course directors. Part 2 and 3 is assessed by the course directors and an external examiner.

Grading

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.

Student workload

Preparation: 40 hours
Confrontation, first week: 40 hours
Protocol writing: 20 hours (between the two confrontation weeks)
Confrontation incl. examination, second week: 40 hours
In total 140 hours

Course directors

Professor Ole J. Bjerrum and professor Per Hartvig Honoré, Department of Pharmacology and Pharmacotherapy, The Faculty of Pharmaceutical Sciences, University of Copenhagen.

Lecturers

List of lecturers may be subject to change.

• Alejandra Mørk, Klifo
• Anders Grahnén, Uppsala University
• Christian Gluud, CTU, Rigshospitalet – Copenhagen University Hospital
• Connie Brendstrup, Roche
• Ewa Lindenstrøm, EL Medical Consulting
• Frank Larsen, Lundbeck
• Helle Northeved, Lundbeck
• Helmer Ring-Larsen, Faculty of Pharmaceutical Sciences
• Henrik Tang Vestergaard, Danish Medicines Agency
• Ingrid Wallenbeck, Swedish Medicines Agency
• Jane Arce, Nordic Trial Operations
• Jens Peter Balling, Lundbeck
• Judith Jacobsen, Statcon ApS, Biostatistic Department, Faculty of Health Sciences
• Mette Damholt, Rigshospitalet
• Morten Mau-Sørensen, Finsen Institute
• Ove Andersen, Hvidovre Hospital
• Per Hartvig Honoré, Faculty of Pharmaceutical Sciences
• Peter Matzen, Hvidovre Hospital
• Steen Ingwersen, Novo Nordisk

Practical information

Status: Master's level (second-cycle). Compulsory for MIND students, elective for other part-time master's students at the Faculty of Pharmaceutical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

Date: 10-14 October and 31 October-4 November 2011. Examination on the last day of the course.

Application deadline: 1 August 2011. Application form. Closed for applications.

Course credits: 5 ECTS credits  =  a student workload of approx. 140 hours

Course fee: Part-time master’s students at Faculty of Pharmaceutical Sciences DKK 14,920, freelance students DKK 17,840, freelance students from non-EU/EEA countries DKK 22,580. An additional fee of DKK 2,300 is charged for course materials and lunch. Prices may be subject to change.

Course capacity: 24 participants

Language of instruction: English

Approved by the MIND/MPRA study board 27 August 2010.