Clinical Pharmacology and Biostatistics

Course content

The course covers the transition process of drug candidates from the preclinical stage to clinical evaluation. The red thread comprises the writing of a full trial protocol done in groups. The theoretical aspects cover clinical trial designs, PK/PD methodology, selection of special patient populations, and regulatory requirements.  Special emphasis will be put on biostatistics including theory, considerations and hands-on calculations for practical use. Aspects special for biopharmaceuticals will be highlighted. Further an introduction will be given to in silico trial simulation.

Education

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.

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, organization 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
  • explain comprehensively the transition process from nonclinical studies to human clinic
  • demonstrate knowledge of basic clinical pharmacology as prerequisites for planning a clinical trial
  • give an account of pros and cons for available trial designs
  • demonstrate knowledge of pharmacometrics to optimise trial design
  • define the biostatistical concepts for a clinical trial
  • give an account for the value and limitation of use of surrogate endpoints
  • describe the regulatory requirements for conducting a clinical trial


Skills

  • master the design, the organisation and writing of a protocol on a clinical trial to be valid for the authorities and the clinicians
  • calculate the biostatistics and the power of a clinical study
  • analyse and react on the results of available pharmacometric information
  • identify and define special patient populations for the trial
  • substantiate the design chosen for a clinical study


Competencies

  • independently to plan and critically evaluate a clinical trial
  • translate safely the dosing information from the nonclinical to the clinical setting
  • conduct a clinical trial according to the regulatory requirements
  • liaise and communicate professionally with stakeholders involved in execution of a clinical trial using relevant terminology

Lectures, tutorials and group discussions.

Chapter 6-10 in Pharmaceutical Medicines ed. J.P Griffin  7th ed. 2013 (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.

It is recommendable to have completed the MIND course Pharmacology before taking this course.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Besides the attendance in the class, some evenings between the two course weeks should be set aside for being able to prepare and write the trial protocol. This because the protocol is central for the achieving the learning outcome of the course

Oral
Collective
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
Peer feedback (Students give each other feedback)
ECTS
5 ECTS
Type of assessment
Practical oral examination
Examination design:
During the course the students work on a trial protocol. The protocol is handed in to the course responsible so early that it can be assessed before the oral examination on the last day. The trial protocol can be written in Groups (2-4 persons).
Each student presents part of the protocol in plenum to be defended for cross examination by the fellow peers, the examinator and the censor. 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 oral presentation.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
External censorship
Criteria for exam assessment

 

The purpose of the examination is to test that the examinee has a broad knowledge and comprehension of clinical pharmacology in drug development. To achieve grade 12 the student must be able to:

Knowledge

  • understand the transition process from nonclinical studies to human clinic
  •  
  • describe the content for full protocol for a clinical trial according to current regulatory guidelines and GCP
  •  
  • understand basic clinical pharmacology concepts, pharmacometrics and biostatistics
  •  
  • understand proof of concept of efficacy and safety in the clinical setting
  •  
  • explain the use of clinical hard endpoints and the use of biomarkers as surrogate endpoints
  •  

Skills

  • Evaluate conditions and designs for performing First-in-human studies, exploratory and confirmatory trials

  • apply the correct biostatistical concepts and calculations for a clinical  trial

  • select groups at risk for a trial

  • evaluate regulatory requirements for a given trial

Competences

  • Translate preclinical knowledge into a full trial protocol
  •  
  • Respond to regulatory requirements for a given trial

  • Integrate the correlation between pharmacokinetics, pharmacodynamics and safety of a drug candidate into a dosage and treatment scheme

  • Take responsibility for planning and setting up a correct clinical trial to be used for authorization purpose

 

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 59
  • Lectures
  • 30
  • Project work
  • 30
  • Theory exercises
  • 20
  • Exam
  • 1
  • English
  • 140