Basics of Clinical Trials 2011

Hyatt Regency Hotel

Orange County, CA

November 17, 2011

1:45pm-5:00pm

 

 

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