Proposals Not Requiring NMDP Repository Samples

Guidelines for Submission of Proposals
Not Requiring NMDP Repository Samples

The rules of the CIBMTR state that anyone may propose a study. The person proposing the study must complete a Study Proposal Outline (see below). Materials are reviewed by the relevant Working Committee statisticians to determine whether the necessary data are captured and patient numbers are adequate. The proposal is then presented to the Statistical Center scientific staff. Studies deemed feasible and consistent with the CIBMTR's scientific goals are forwarded to the Working Committee Chairs for further input and assignment of a priority score by the full Working Committee at the annual BMT Tandem meetings. Some proposals may be accepted as CIBMTR studies (see below) without discussion at the annual Working Committee meeting, if judged to be of exceptional merit by the Working Committee Chairs and/or if they use existing data and will be analyzed by non-Statistical Center personnel, but most proposals will be deferred to this meeting for discussion by the larger group.

Proposals are formally accepted as CIBMTR studies and assigned a protocol number at the discretion of the Working Committee Chairs and Scientific Director based on priority scores, competing projects and available resources. A formal protocol document is then completed by the Principal Investigator using the original proposal model and incorporating recommendations of the Working Committee and Statistical Center. A Writing Committee is formed to supervise the study. Interested members of the Working Committee and others are permitted to serve on the Writing Committee. To assure co-authorship of the manuscript, members of the Writing Committee must make timely and substantive contributions to study design, data analysis, interpretation of results or preparation of the typescript for publication. Members of the Writing Committee who do not fulfill this requirement are expected to withdraw as a co-author or, alternatively, their names may be deleted by the Principal Investigator. Disputes regarding authorship will be referred to the Working Committee Scientific Director or, if not resolved, to the Executive Committee.

The person awarded primary responsibility is required to prepare a first draft of the typescript within 60 days of the first receipt of data from the CIBMTR. Failure to do so can result in forfeiture of lead authorship.

Suggested Proposal Outline for
Proposals Not Requiring NMDP Repository Samples

Prepare a brief description of the proposed study as you envision it. This should be no more than three pages, using standard 8½" X 11" paper with 1" margins. Use the outline below and send your description to the cibmtr@mcw.edu.

Study Title

Include the name(s) and institution(s) of the individual(s) proposing the study.

Specific Aims

State the primary purpose(s) of the study as concisely and clearly as possible. A reader should have a clear idea of the purpose for which the data will be analyzed.

Scientific Justification

Summarize the rationale of the study, citing relevant previous work. This should convey the importance of the intended study.

Patient Eligibility Population

Include the study requirements for age, disease, disease stage, years of transplant, graft and donor type, prior treatment, specific transplant regimens or any other restrictions relevant to the study. If the study involves combining CIBMTR data with data from another group, the selection criteria for patients from the other database should also be specified including how the additional data will be obtained and when.

Include a list of variables you believe will be informative and the outcome variables you wish to analyze. Specify whether additional data would have to be collected and how this would be accomplished.

Data Collection

Please visit cibmtr.org to assess existing data collection forms or contact the CIBMTR Statistical Center (cibmtr@mcw.edu) to inquire. If your study will require supplemental data collection, the specific variables and data collection plan should be specified.

Study Design (Scientific Plan)

Describe, in non technical terms, how the specific aims would be addressed using information from the CIBMTR database. It should include the specific statistical methodology planned, with discussion of limitations, if relevant. Statistical Center staff members are available to provide assistance, including relevant power calculations, if necessary.

E-Mail your proposal to: cibmtr@mcw.edu

Letters of invitation for proposals for observational studies to the CIBMTR are distributed by broadcast email twice annually, once in late spring and once again in late summer. There is a mid-December deadline for proposals to be included in the agenda of the Working Committee meetings at the annual BMT Tandem meetings. Proposals, however, are welcome throughout the year.