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Centre for Cancer Biomarkers CCBIO
CCBIO Research School

Clinical Trials in Cancer Research

New course in the portfolio of the CCBIO Research School of Cancer Studies.

Doctors discussing a medical case.
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Course title: "Clinical Trials in Cancer Research"

Responsible for the course: Line Bjørge and Hani Gabra.

Date: October 3 and 4, 2019

Registration: Registration link will be available at a later point.

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:

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?

  • The Norwegian Cancer Society Why clinical trials from the patients’ perspective?

12.00-12.45 Lunch

12.45 - 13.45
Part II. Study structure
Bente Vangen, Bergen and Ingunn Heie Anundskås, Bergen

An overview of the following subjects will be given: Roles and responsibility (sponsor vs.investigator). protocols, data monitoring and important study specific terminology

13.45 -14.45
Part III. Operations: : From planning to completion
Cathrine Hartveit, Bergen and Marianne Flatebø, Bergen

An overview of the following subjects will be given, feasibility budgeting and contracts, inform concent, recruitment, source documents, data management / eCRF, safety, reporting, closure

14.45 -15:00 Coffee brake

15:00 – 15.30
Part IV. Formalities and regulations
Anne-Mathilde Kvamme, Bergen and Christer Kleppe, Bergen:

An overview of the following subjects will be given: GCP, reporting, authorities, rules for data protection, insurance, study registries and NorCRIN

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

October 4

Kl. 9.00 -11.30
Part VI. How to succeed?

  • Kreftforeningen: The patients’ perspective

  • Oddbjørn Straume, Bergen: Melanoma studies

  • Fredrik Hellem Schjesvold, Oslo: Multiple myeloma – The Oslo experience

  • Mansoor Raza Mirza, Copenhagen: NSGO - from a Nordic interest group to a global leader in clinical trials

11.30-12.30 Lunch

12.30 – 14.30
Part VII. Clinical trials in the future

  • James Matcham, Cambrigde Design of clinical trials in the future

  • Donal Landers, Manchester Digital experimental medicine in Oncology

  • Ketil Widerberg, Oslo How artificial intelligence can improve clinical trials

  • The Norwegian Cancer Society: Use of patients as co-scientists / Decision aids

Kl 14.30 -15.00
Summary and conclusion