Clinical Trials in Cancer Research

Course title: "Clinical Trials in Cancer Research"

Responsible for the course: Line Bjørge and Hani Gabra.

Date: October 3 and 4, 2019

Where:
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 1, 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 
• Operations
• Formalities
• Regulations

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.

Program:

Thursday October 3

09:30–10:00 Registration

10:00–12:00

Welcome

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)

12:45–13:45

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

13:45–14:45

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

15:00–15:30

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,

15:30–16:00

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

09:00–11:30

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)

12:30–14:30

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

14:30–15:00

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.