Overview

The Society for Neuro-Oncology is pleased to announce the 5th Annual Introduction to Clinical Trial Design and Protocol Development Workshop. The workshop will be held in person on Wednesday, November 15, in Vancouver, Canada, just prior to the SNO Annual Meeting and Education Day, with participants who were selected earlier in the year based on a competitive application process

The 2023 workshop offers two participation options:

• Group 1 provides an introduction to protocol development for participants without prior experience writing a clinical trial protocol or conducting clinical research.
  • Intended for trainees or junior faculty who have no prior experience writing clinical trial protocols or conducting clinical trials.
  • Uses lectures and small-group breakout sessions guided by faculty mentors to familiarize participants with the basic elements of developing a clinical trial protocol.
  • Viewing of re-recorded educational material is required in advance of the workshop.
  • Applicants do not need to have a specific clinical trial concept in mind upon applying to the workshop. However, following acceptance to the workshop, participants will be expected to provide an LOI to be discussed at the workshop.
  • Participants in Group 1 in 2023 will be encouraged to apply for Group 2 in 2024.
• Group 2 addresses the essentials of effective clinical trial design in the treatment of CNS malignancies and focuses on small group mentoring to provide tailored feedback to the participants. The overall objective is to provide guidance about the design, activation and conduct of clinical trials in neuro-oncology. These trials can span the adult and pediatric population and involve multidisciplinary modalities of treatment as well as non-therapeutic interventions related to biomarkers and quality of life.
  • This educational offering is intended for trainees or junior faculty who 1) already have a basic understanding of the key elements of clinical trial design and protocol writing and 2) have a specific clinical trial concept that they would like to further develop at the workshop.
  • Scholars will work closely with their assigned mentors, who all have extensive experience in neuro-oncology clinical trials, both before the actual workshop and during small-group breakout sessions at the workshop to develop their concept into an actual clinical trial protocol. There will also be an opportunity for continued mentorship following the workshop.
  • Viewing of re-recorded educational material is required in advance of the workshop.
  • Applicants for this group must submit a synopsis of a specific clinical trial proposal with their application.
  • Group 1 participants from 2022 are encouraged to apply.

A total of up to 75 participants will be selected to attend the workshop through a competitive application process, with up to 50 participants selected for Group  1 and up to 25 participants selected for Group 2. Applicants will select their preferred Group in the application, but the Course Planning Committee reserves the right to make final Group selections for each participant. 

Educational Goals:
Upon completion of this course, participants will have an improved understanding of the practical aspects of CNS trials, including: 

• Understanding the fundamentals of good trial design and protocol development,
• Understanding the scientific, statistical, regulatory, logistical and ethical aspects of CNS trials,
• Integrating correlative studies in CNS trials,
• Mitigating challenges to accrual and overcoming accrual barriers, and
• Anticipating the future direction of CNS trials.

Eligibility:
Participation in the course is through a competitive application process and is open to clinical fellows, and junior clinical faculty (faculty must be within 7 years from first appointment) from all neuro-oncology subspecialties (neuro-oncology, medical oncology, radiation oncology, neurosurgery, pediatric oncology). Applications will also be considered from residents in neurology, radiation oncology, neurosurgery, internal medicine, and pediatrics if there is strong interest in a career in neuro-oncology. Applicants from traditionally underrepresented groups are strongly encouraged to submit applications. SNO membership (Full or Trainee Level) is required.   
 
Upon completion of the course, all scholars will be provided with a certificate of completion from the Society for Neuro-Oncology. If you have previously participated as a scholar in Group 1, you are encouraged to apply to Group 2. Please note, this is a one-time opportunity. Past scholars may not repeat participation in the same group. 

Workshop Application Procedure:
The online application required the following items to be received in the SNO administrative office by the application deadline of June 30, 2023: 

• Statement of interest explaining why you wish to participate in this course.
• Your personal CV (pdf)
• Letter of support from your Program Supervisor or Department Head
• Brief clinical trial concept (Group 2 applicants only)

Scholarship Opportunity for International Applicants:
The Society for Neuro-Oncology understands that brain tumors do not recognize geographical boundaries. SNO seeks to promote clinical and research activities in both pediatric and adult neuro-oncology in developing regions of the world. Travel scholarships to attend the 2023 Clinical Trial Design and Protocol Development Workshop will be awarded to two (2) international attendees from Low- and Middle-Income Countries (LMIC) as defined by the World Bank.  For a list of eligible countries, visit the World Bank data page and reference the low-income, lower-middle income, and upper-middle income lists.

In order to be considered for one of the Travel Scholarships, the applicant must meet the following guidelines: 

• Work and live outside the United States or Canada
• Be a medical professional with a focus in neuro-oncology
• Has not previously received the scholarship for a past SNO meeting
• Could otherwise not attend without the benefit of a travel scholarship
• Have no visa issues entering the United States or Canada (SNO cannot provide visa assistance other than providing a letter of invitation)
• Complete Application for this 2023 Clinical Trial Design and Protocol Development Workshop

Scholarship recipients will receive: complimentary registration to the Workshop and will be able to register at the trainee rate for the SNO Annual Meeting and Education Day, being held November 16-19 in Vancouver, Canada; hotel accommodations; and a $1,750 stipend to be applied to costs associated with meals and travel to the conference.

Registration:
Workshop registration for accepted applicants is $135.

Planning Committee:

• Stephen Bagley, University of Pennsylvania
• Susan Chang, University of California, San Francisco
• Maryam Fouladi, Nationwide Children's Hospital
• Susan Geyer, Mayo Clinic
• Mustafa Khasraw, Duke University
• Ian Parney, Mayo Clinic
• Patrick Wen, Dana-Farber Cancer Institute
• Jennifer Yu, Cleveland Clinic;