8th Annual Clinical Trial Design and Protocol Development Workshop

Event Notes:

Effective neuro-oncology treatment that encompasses both primary benign and malignant CNS tumors and metastatic CNS tumors remains a largely unmet clinical need with poor prognosis for many patients despite aggressive treatment with standard modalities (surgery, radiation, chemotherapy). Increased availability of and participation in well-designed clinical trials in neuro-oncology is vital for establishing new, effective treatments for CNS tumor patients. This course will emphasize communication across multi-disciplinary teams and provide foundational didactic background knowledge and unique mentored clinical trial design opportunities. This will also allow for collaboration between new and emerging investigators leading neuro-oncology clinical trials and members of the clinical research team to expand the number and quality of clinical trials available to patients with CNS tumors.

Participants are able to collect CME credit. Those in the Clinical Research/Allied Health group will receive a certificate of participation and will need to check with their state licensing board and specialty certification board to determine how to apply CME credit to their license and certification.

The 2026 workshop offers three participation options:

• Clinical Research, Part 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 a Letter of Intent (LOI) to be discussed at the workshop using a supplied template.
• Viewing pre-recorded educational material is required before submitting a draft LOI before the workshop.
• Participants in Clinical Research, Part 1 will be encouraged to apply for Clinical Research, Part 2 in 2026.
• Clinical Research, Part 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 Clinical Research, Part 1 participants are encouraged to apply.
• Clinical Research/Allied Health 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, nurses, physician assistants (PAs), and advanced practice providers.
• 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.