Multi-Disciplinary Organization Dedicated to Promoting Advances in
Neuro-Oncology Through Research and Education

WFNOS Magazine

The inaugural issue of the official publication of the World Federation of Neuro-Oncology Societies is ...

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Neuro-Oncology Review Course at SNO

November 16, 2016. Register in conjunction with the SNO Annual Meeting

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CNS Anticancer Drug Discovery and Development Conference

Register Now!

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October
12

EANO 2016

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October
22

18th Annual Brain Tumor Update and 7th Annual International Symposium on Long-Term Control of Metastases to the Brain and Spine

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November
16

2nd CNS Anticancer Drug Discovery/Development Conference

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Basics of Clinical Trials 2011

SNO/Section on Tumors Course on the Basics of Clinical Trials 2011

Hyatt Regency Hotel
Orange County, CA
November 17, 2011
1:45pm-5:00pm
 

Course Directors: Susan Chang, Mark Linskey

This course will take place during the Education Day of the Annual SNO Meeting on Thursday, November 17, 2011.  The course is open to young investigators at no additional charge as part of the conference registration fee, but attendees must confirm their participation by checking the appropriate box when registering for the meeting. To register, click here.


Overview

 
There are known challenges to performing clinical trials in neuro-oncology. Surgically based neuro-oncology clinical trials address issues of more extensive tumor resections, evaluation of targeted therapies, improved drug delivery, immunotherapy, gene therapy, stem cell therapy and brachytherapy. These studies have unique aspects in terms of trial design, conduct and evaluation.
 
To highlight the challenges of neuro-oncology trials with an emphasis on surgically based studies, a three hour educational workshop is planned for young investigators that will focus on topics pertinent to clinical trials. Members of the tumor section and SNO who have served as a Principal Investigator of clinical trials, will review trial endpoints, response assessments, evaluation of treatment toxicities as well as statistical considerations. Regulatory requirements for applications to the Federal Drug Administration and Institutional Review Boards will also be reviewed.
 
The goal of this workshop is to engage young investigators in academic or community settings and to provide a forum for discussion of these important aspects of clinical research.

Thursday, November 17, 2011
Course start time: 1:45pm 
Topic
Presenter
Comments
Time allotted
Introduction
Susan Chang
Overview of course objectives, historical perspective of clinical research in Neuro-Oncology
10 min
Phase 0 and I trials- how can they expedite the clinical research agenda
Howard Colman
Standard phase I: Objectives, CTC 4 criteria, DLT and MTD definitions,
SAE reporting. Discussion of targeted therapies- challenges using standard MTD vs optimal dosing and introduction of phase 0 studies. 
15 min presentation
5 min discussion
Challenges in Phase II trial design
Eva Galanis
RANO paper summary on phase II trial design (single arm vs randomized phase II design),
endpoint selection, statistical considerations
15 min presentation
5 min discussion
Overview of the basics of Phase III trials
Mark Gilbert
Consort statement- randomization, placebo, blinding, intent to treat,
phase II/III designs
15 min presentation
5 min discussion
Break
 
 
 
15 min
Challenges of response assessment/endpoint evaluations for surgically based studies
Mike Vogelbaum
RANO paper summary on surgically based studies
15 min presentation,
5 min discussion
Responsibilities of a PI
 
Manish Aghi
Expectations from the PI and what duties can be delegated
15 min presentation,
5 min discussion
Overview of Regulatory Requirements
(Institutional and FDA)
James Markert
Steps involved with the regulatory approval process for clinical trials
20 min presentation,
5 min discussion
Personal experience in conducting a clinical trial- pearls and pitfalls
 
Nino Chiocca
Road-blocks and
obstacles
Advice regarding what to think about to ensure success, how to proactively plan for conducting a trial
20 min presentation,
5 min discussion
Summary
Mark Linskey
Provide resources for formal courses (AACR/ASCO, AAN, NIH)
5 min