Kursplansdatabas för forskarutbildningskurser
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Kursplansdatabas för forskarutbildningskurser
KURSPLANER FÖR FORSKARUTBILDNINGSKURSER
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| Svensk benämning | Klinisk cancerforskning: från laboratorieupptäckter till kliniska tillämpningar |
|---|---|
| Engelsk benämning | Clinical cancer research: from laboratory discoveries to clinical trials |
| Kursnummer | 2941 |
| Antal högskolepoäng | 1.5 |
| Kursansvarig institution | Institutionen för onkologi-patologi |
| Särskild behörighet | |
| Betygsskala | Godkänd/Icke godkänd |
| Fastställd av | The Board of Doctoral Education |
| Datum för fastställande | 2016-09-08 |
| Kursens syfte | The purpose of the course is to give students insight into translation from laboratory discovery to clinical application and design of clinical trials. |
| Kursens lärandemål | 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. |
| Kursens innehåll | 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. |
| Arbetsformer | Lectures, group discussion, presenting a synopsis for a clinical trial |
| Obligatoriska moment | 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. |
| Kurslitteratur och övriga läromedel | Recent and relevant articles distributed prior to the course. | Kursansvarig |
Teresa Frisan Institutionen för cell- och molekylärbiologi 08-52486385 Teresa.Frisan@ki.se Berzelius väg 35 S-17177 Stockholm |
| Kontaktpersoner |
