SLVKB0382U  Methods and Procedures in Clinical Drug Development

Volume 2018/2019
Education

MSc Programme in Pharmaceutical Sciences: Track III (English programme) - compulsory

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme) - elective

Content

The regulatory guidelines and principles around pre-clinical and clinical research will be reviewed. During the last weeks of the course, the students will develop a clinical trial protocol based on a medical case and prepare a project report. The core focus areas will be:

  • Regulatory requirements for clinical trial protocols in Denmark and abroad
    • The Danish Medicines Agency
    • The Ethics Committee system
    • Data Protection Agency
  • Principles for the development of pre-clinical documentation
    • Drug discovery
    • Preclinical safety pharmacology and toxicology
  • Clinical drug development
    • Clinical research methodology – the randomised clinical study design
    • Clinical trials
      • Human pharmacology
      • Therapeutic exploratory
      • Therapeutic confirmatory
      • Therapeutic use
      • Health economics and outcomes studies
    • Good Clinical Practice
    • The pharmaceutical industry’s involvement in clinical development plans and protocols
    • The conduct and monitoring of clinical trials
    • Clinical supply chain activities and study drug management
    • Safety surveillance and pharmacovigilance
    • Clinical research from the investigator perspective
    • Data management
    • Medical writing and study publications
    • Medical devices
    • Quality assurance, audits and inspections
Learning Outcome

The aim of the course is to give students knowledge about the preclinical and clinical methodology used to generate the evidence necessary for getting marketing authorisation of a drug. Furthermore, to give insight into the ethical, regulatory and guideline framework around clinical drug development. The course provides a description of the main areas, processes and key functions in the pharmaceutical industry that contributes to the planning, design and practical conduct of clinical trials.

 

After completing the course the student is expected to be able to:

 

Knowledge

  • explain preclinical and clinical research methods used as basis for the approval of drugs. 
  • explain ethical, regulatory and guideline requirements of clinical studies.
  • define, summarize and identify the main areas, processes and key functions in the pharmaceutical industry that contributes to planning, design and practical conduct of clinical drug development.

 

Skills

  • describe and analyze the regulatory requirements for pre-clinical and clinical trials used to register drugs.
  • put structure to and evaluate the clinical development process of a drug in the pharmaceutical industry
  • describe and master the main principles of Good Clinical Practice, including roles/responsibilities of sponsors, monitors and investigators.
  • assess and discuss the main quality assurance aspects and ethical dimensions of importance in clinical drug development.

 

Competences

  • independently develop, plan, coordinate and implement clinical trial protocols for studies in healthy volunteers and patients across all 4 phases of Drug Development.

Laws, documents, recommendations, circulars, guidelines and scientific papers.

Course teaching is based on the assumption that students have knowledge corresponding to the content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy, Toxicology and Drug Production.
Lectures: 40
Classroom discussions: 6
Case project and report: 70
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Credit
7,5 ECTS
Type of assessment
Written assignment
Course participation
In order to obtain the course certificate the students should:
* develop a project report of clinical trial protocol based on a medical case. The report will be developed during the last weeks of the course.
* Participate in the internal evaluation of the project report
* Participate satisfactorily throughout the course.
Participation in group work and presentation of project report is mandatory.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

To obtain a course certificate the student must be able to:

 

Knowledge

  • explain preclinical and clinical research methods used as basis for the approval of drugs. 
  • explain ethical, regulatory and guideline requirements of clinical studies.
  • define, summarize and identify the main areas, processes and key functions in the pharmaceutical industry that contributes to planning, design and practical conduct of clinical drug development.

 

Skills

  • describe and analyze the regulatory requirements for pre-clinical and clinical trials used to register drugs.
  • put structure to and evaluate the clinical development process of a drug in the pharmaceutical industry
  • describe and master the main principles of Good Clinical Practice, including roles/responsibilities of sponsors, monitors and investigators.
  • assess and discuss the main quality assurance aspects and ethical dimensions of importance in clinical drug development.


Competences

  • independently develop, plan, coordinate and implement clinical trial protocols for studies in healthy volunteers and patients across all 4 phases of Drug Development.
  • Category
  • Hours
  • Lectures
  • 40
  • Preparation
  • 80
  • Theory exercises
  • 6
  • Preparation
  • 10
  • Project work
  • 70
  • Total
  • 206