Overview
The Society for Neuro-Oncology is pleased to announce the 6th Annual Introduction to Clinical Trial Design and Protocol Development Workshop. Recognizing the critical role of clinical research team members,
new this year is the addition of complementary sessions designed for clinical research coordinators, nurses, physician assistants, and advanced practice providers who are interested in learning more about clinical trial design and implementation. The workshop will be held in person on Wednesday, November 20, in Houston, Texas, just prior to the SNO Annual Meeting and Education Day.
The 2024 workshop offers three participation options:
- Group 1 provides an introduction to protocol development for participants without prior experience writing a clinical trial protocol or conducting clinical research. (see eligibility below)
- 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.
- Applicants do not need to have a specific clinical trial concept in mind when applying to the workshop. However, following acceptance to the workshop, participants will be expected to provide an LOI to be discussed at the workshop.
- Viewing pre-recorded educational material is required before submitting a draft LOI before the workshop.
- Participants in Group 1 in 2024 will be encouraged to apply for Group 2 in 2025.
- 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. (see eligibility below)
- 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 pre-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.
- Previous Group 1 participants are encouraged to apply.
- Group 3 provides an introduction to the basics of neuro-oncology and key aspects of clinical trial activation, conduct and oversight. An understanding of the roles and responsibilities of the research team members and the specific considerations for neuro-oncology focused trials will be the emphasis. (see eligibility below)
- Intended for all members of the clinical research team—clinical research coordinators (CTCs), nurses, physician assistants (PAs), and advanced practice providers (APPs).
- Uses lectures and small-group breakout sessions guided by faculty mentors to familiarize participants with the basic elements of neuro-oncology and the development and management of a clinical trial protocol.
- Viewing of pre-recorded educational material is optional in advance of the Workshop.
- Participants in Group 3 will have the Workshop fee waived.
A total of up to 85 participants will be selected to attend the workshop through a competitive application process, with up to 30 participants selected for Group 1, up to 25 participants selected for Group 2, and up to 30 for Group 3. The Course Planning Committee reserves the right to make final Group selections for each participant.
Educational Goals
Upon completion of this course, participants in Groups 1 and 2 will have an improved understanding of the practical aspects of CNS trials, including:
- the fundamentals of good trial design and protocol development,
- the scientific, statistical, regulatory, logistical and ethical aspects of CNS trials,
- Integration of correlative studies in CNS trials,
- Mitigating challenges to accrual and overcoming accrual barriers, and
- Anticipating the future direction of CNS trials.
Participants in Group 3 will have an improved understanding of some basic aspects of neuro-oncology and an overview of the clinical trial enterprise including:
- the classification of brain tumors
- common symptoms and medications used in brain tumor patients
- basic clinical trial design and endpoints
- elements to launch a trial
- post activation clinical trial activities
Eligibility
For Groups 1 and 2: 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 unless from an LMIC, which has no restriction) 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.
For Group 1 in particular, PhDs working within clinical trials may also apply if they are working with a clinical mentor or collaborator. Applicants from traditionally underrepresented groups are strongly encouraged to submit applications. SNO membership (Full or Trainee Level) is required.
For Group 3: Participation in the course is through a competitive application process and is open to research personnel (Clinical Research Coordinators (CTCs), Advanced Practice Providers (APPs), Physician Assistants (PAs) and Nurses) from all neuro-oncology subspecialties (neuro-oncology, medical oncology, radiation oncology, neurosurgery, pediatric oncology). Applicants from traditionally underrepresented groups are strongly encouraged to submit applications. SNO membership (Full or Trainee Level) is NOT 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 requires the following items to be received in the SNO administrative office by the
application deadline of June 28, 2024:
- Statement of interest explaining why you wish to participate in this course – Groups 1, 2, and 3
- Letter of support from your Program Supervisor or Department Head – Groups 1, 2, and 3
- Your personal CV (pdf) -- Groups 1 and 2 only
- Brief clinical trial concept -- Group 2 only
To apply,
click here. Notification of acceptance will be sent in July.
Registration
Workshop registration will be open to all accepted applicants in July at $135 USD, excluding Group 3.
For any questions, please contact Kris Knight,
[email protected].
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
- Jane Rabbitt, University of California, San Francisco
- Patrick Wen, Dana-Farber Cancer Institute
- Jennifer Yu, Cleveland Clinic