Clinical Trials in Cancer Research
New course in the portfolio of the CCBIO Research School of Cancer Studies.
Course title: "Clinical Trials in Cancer Research"
Date: October 3 and 4, 2019
October 3 in the auditorium, Womens's Clinic, Jonas Lies vei 72.
October 4 starts in the auditorium, Womens's Clinic, and will from Part VII at 12:30 be in Auditorium 4, BB-Building. Jonas Lies vei 91.
Registration through this link: https://skjemaker.app.uib.no/view.php?id=6832514
Preparing participants to conduct clinical trials
Clinical trials are studies performed in humans aimed at evaluating one or more medical surgical or behavioral intervention(s), and trials are the primary method to determine whether a new treatment is safe and effective. Most often a clinical cancer trial compare the most effective known treatment for a specific type or stage of cancer with a new approach although other designs are used more and more. Today clinical trials for almost every type of cancer and the numbers are increasing. While many trials focus on late stage disease there are also trials for cancer prevention and early diagnosis, and prevention of recurrence and survivorship.
The course will consist of 6 different modules. First day will cover:
- General principles
The second day will focus on:
- Success factors
- Clinical trials in the future
The course is designed to prepare the participants to conduct clinical trials in humans. The modules included will be based on the ICH_GCP, and the participants will receive a certificate in Good Clinical Practice on completion of the course.
The course will be led by Professor and Associated Investigator Line Bjørge at the Centre for Cancer Biomarkers CCBIO and Professor and CCBIO International Affiliated Investigator Hani Gabra, Imperial College of London, London and AstraZeneca, Cambridge, UK.
The course is not applicable for ECTS.
Thursday October 3
Part I. Clinical trials - General
Bjørn Tore Gjertsen, Bergen: Why clinical trials? What is a clinical study?
Nina Jebsen, Bergen: Different study designs
Yngvar Fløisand, Oslo: How to run a clinical trial in at clinical department / at a clinical research unit
Camilla Tøndel, Bergen: Differences between children and adults in clinical trials?
Elin Anthonisen, The Norwegian Cancer Society: Why clinical trials from the patients’ perspective?
12:00–12:45 Lunch (included)
Part II. GCP overview
Anne Mathilde Kvamme, Bergen and Cathrine Hartveit, Bergen:
An overview of the following subjects will be given: GCP principles, Planning, Authorities, Responsibilities and Tasks, Sponsor – PI – DMC / committees
Part III. Running a clinical trial
Ingunn Anundskås, Bergen and Bente Vangen, Bergen:
An overview of the following subjects will be given: Protocol, IMP Recruitment and inclusion, Patient information/consent, safety, deviations, medical notes and CRF completion, study drug, study archive
14:45–15:00 Coffee break
Part IV. Formalities and regulations
Marianne Flatebø, Bergen and Christer Kleppe, Bergen:
An overview of the following subjects will be given: Monitoring, insurance, NorCRIN, study registries, data protection,
Part V. Translational research protocols
Line Bjørge, Bergen: Translational research in clinical trials
Hani Gabra, London: Design of translational research protocols
Redun Kopperud, Bergen: Biobanking
Friday October 4
Part VI. How to succeed?
Patient representative: The patients’ perspective
Oddbjørn Straume, Bergen: Melanoma studies
Fredrik Hellem Schjesvold, Oslo: Multiple myeloma – The Oslo experience
Line Bjørge, Bergen: NSGO - from a Nordic interest group to a global leader in clinical trials
11:30–12:30 Lunch (included)
Part VII. Clinical trials in the future
Fredrik Öhrn, Gothenburg: Design of clinical trials in the future
- Tove Skjelbakken, Tromsø: Decision aids
Donal Landers, Manchester: Digital experimental medicine in Oncology
Ketil Widerberg, Oslo: How artificial intelligence can improve clinical trials
Summary and conclusion
As Part VII also doubles as a CCBIO Special Seminar and takes place in Auditorium 4, BBB, there will be an informal pizza-get-together following the last session.