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Center for International Blood and Marrow Transplant Research

Working Committee Study Proposal Outline

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Use the outline below to draft a formal observational study proposal. CIBMTR accepts observational study proposals throughout the year. Additionally, letters of invitation are distributed by e-mail three times per year. To be considered for inclusion as part of a Working Committee meeting agenda at the 2027 Tandem Meetings I Transplantation and Cellular Therapy Meetings of ASTCT & CIBMTR, proposals must be received by September 21, 2026.

For 2027, CIBMTR will implement several new refinements to enhance prioritization, engagement, and impact:

  • Fewer proposal presentations: The committee will limit presentation time during in person working committee meetings to approximately 3-5 high impact proposals to prioritize studies with the greatest potential to change practice and to support completion of ongoing work.
  • **NEW** Community-informed proposal selection: The committee will share short summaries of selected proposals in advance of the Tandem Meetings and will invite the community to rank priorities through a structured survey. The committee will circulate the survey to committee members at the end of October and will allow three weeks for responses. Survey results will help determine which proposals the committee presents at the Tandem Meetings.
  • Expanded focus of meetings: With fewer proposal presentations, the committee will dedicate additional meeting time to high-priority topics, such as study progress, backlog transparency, data considerations, and strategic scientific direction.

Please note, this change to proposals is planned for 2027 only. Following the 2027 Tandem Meetings, we will gather community feedback through a survey on this year's proposal approach to help inform decisions for future years.

Updates to the proposal submission process from last year (2026 Tandem Meetings) remain in place. Specifically:

  • Proposals will not be accepted from individuals who are:
    • Listed as first or senior author on a manuscript that has been in preparation for more than one year, or 
    • Serving as first or senior principal investigator (PI) on two or more current CIBMTR studies.
  • All other individuals may submit as many as two proposals to CIBMTR for consideration.

Proposals should be submitted to: 

Study Proposal Submission

Proposals should include:

I. Study Title

II. Key Words

III. Principal Investigator Information

  • Name (as many as two)
  • Degree(s)
  • Email address for each researcher (as many as two)
  • Institution name
  • Academic rank
  • Junior investigator status, if applicable 
  • Current ongoing work with CIBMTR, if applicable

IV. Proposed Working Committee

V. Research Question

VI. Research Hypothesis

VII. Short Summary of Project (New: Only for 2027 Proposals)

  • Provide a brief summary of your proposed study that can be shared with the community for input and ranking 

VIII. Specific Objectives/Outcomes to be Investigated

IX. Scientific Impact

  • Briefly state how the completion of the aims will impact participant care / outcomes and how it will advance science or clinical care.

X. Scientific Justification

  • Provide a background summary of previous related research and their strengths and weaknesses, a justification of your research, and an explanation of why your research is still necessary.

XI. Participant Selection Criteria

  • State inclusion and exclusion criteria.

XII. Data Requirements

  • After reviewing data available on CIBMTR forms, list patient-, disease-, and infusion- variables to be considered in the multivariate analyses.
  • Data collection forms are available on the CIBMTR website.
  • Additional data collection is extremely difficult and will make your proposal less feasible.

XIII. Additional Variables Needed 

  • What other variables are needed outside of the standard variables provided (if any) to assess feasibility? 

XIV. Patient-Reported Outcome (PRO) Requirements

  • If the study requires PRO data collected by CIBMTR, the proposal should include: 1) A detailed description of the PRO domains, timepoints, and proposed analysis of PROs; 2) A description of the hypothesis specific to PROs.
  • For additional information on what PRO measures have been collected and timepoints of collection, please visit the CIBMTR PRO Protocol webpage. You can reach out to the CIBMTR PRO Protocol PI for specific questions: Rachel Cusatis (rcusatis@mcw.edu).

XV. Machine Learning

  • Please indicate if the study requires methodology related to machine-learning and clinical procedures.
  • More information about our Bioinformatics Program can be found on the CIBMTR website.
  • Please describe the planned machine-learning/AI methodology and include any additional information you would like the reviewers to know. 
     
    NOTE: AI/Machine Learning approaches will be benchmarked against standard statistical methods (e.g. logistic or Cox regression) for comparison to better understand the added value of AI versus standard methods which are often more easily interpretable. 

XVI. Sample Requirements (if the study will use biologic samples from the CIBMTR Repository)

  • If the study requires biologic samples from the CIBMTR Repository, the proposal should also include a detailed description of the proposed testing methodology and sample requirements and a summary of the investigator's previous experience with the proposed assay systems.
  • PIs should be encouraged to review inventory details, sample types collected and reach out to research_repos@nmdp.org with any questions.
  • More information can be found on the Resources page on the CIBMTR website.

XVII. Non-CIBMTR Data Source, if applicable

  • A description of the external data source to which CIBMTR data will be linked.
  • The rationale for why the linkage is required, i.e., neither database contains all the data required to answer the study question.

XVIII. References 

XIX. Conflicts of Interest

Do you have any conflicts of interest pertinent to this proposal concerning:

  • Employment (such as an independent contractor, consultant, or providing expert testimony)?
  • Relationships (such as executive and advisory committee positions, medical consultant, speaker's bureau)?
  • Ownership (such as equity, ownership, or financial interests)?
  • Transactions (such as honoraria, patents, royalties, and licenses)?
  • Legal (such as pending or current arbitration or legal proceedings)?

If yes, provide detail on the nature of employment, name of the organization, role, entity, ownership, type of financial transaction or legal proceeding, and whether remuneration is more than $5,000 annually.

BEFORE FINAL SUBMISSION, please review the PI checklist to ensure that you have completed all necessary steps. This will increase the likelihood of submitting a feasible and successful proposal.