Syllabus database for doctoral courses
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Syllabus database for doctoral courses
SYLLABI FOR DOCTORAL COURSES
Swedish title | Klinisk cancerforskning: från laboratorieupptäckter till kliniska tillämpningar |
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English title | Clinical cancer research: from laboratory discoveries to clinical trials |
Course number | 2941 |
Credits | 1.5 |
Responsible KI department | Department of Oncology-Pathology |
Specific entry requirements | |
Grading | Passed /Not passed |
Established by | The Board of Doctoral Education |
Established | 2016-09-08 |
Purpose of the course | The purpose of the course is to give students insight into translation from laboratory discovery to clinical application and design of clinical trials. |
Intended learning outcomes | After the course, the student is expected to have obtained basic knowledge about clinical cancer research study design and implementation. The student is also expected to have obtained a basic idea of the regulatory processes involved in clinical research as well as the background for these processes. The student is expected to understand the process for informed consent and the ethical aspects of clinical cancer research. |
Contents of the course | This course covers a wide variety of topics concerning clinical cancer research. The focus will be on both pre-clinical studies using tissue from patients as well as clinical therapy studies. The student will gain insight into drug development from First-In-Human to marketing approval studies. Regulatory aspects with regards to institutional review boards, drug product agencies, radiation protection committees and biobanking will be presented. Ethical issues will be discussed with a focus on informed consent. Study design and statistical aspects of clinical research will be covered. Issues on drug safety will be a part of the course curriculum. Practical and legal aspects of laboratory discovery and patents will be discussed. The basic concepts of GCP (Good Clinical Practise) will be part of the course curriculum. |
Teaching and learning activities | Lectures, group discussion, presenting a synopsis for a clinical trial |
Compulsory elements | All lectures, group discussion and presentations are mandatory. Absence from mandatory parts of the course will be compensated by other activities after discussion with the course leaders. |
Examination | Each student will give an oral presentation on the design of a clinical trial protocol, demonstrating that they have understood the requirements for clinical cancer therapy studies. The course organizers will lead the examination, providing feedbacks during the presentation in line with the concept of formative assessment, and they will be further responsible for the summative individual assessment. |
Literature and other teaching material | Recent and relevant articles distributed prior to the course. | Course responsible |
Teresa Frisan Department of Cell and Molecular Biology 08-52486385 Teresa.Frisan@ki.se Berzelius väg 35 S-17177 Stockholm |
Contact person |