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
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
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.
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?
12.45 - 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
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
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
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
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