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A CIBMTR study number and a provisional timeline is established for those proposals approved by the Working Committee Leadership. The Principal Investigator (PI) is asked to sign a letter of commitment and agrees to place reasonable efforts into completing each stage of study development as efficiently and quickly as possible.
The following describes the stages of study development as they are conducted by CIBMTR Working Committees. The process pertains to studies for which CIBMTR provides both data and statistical expertise. Datasets may be made available to investigators who have their own statistical resources. If utilizing a CIBMTR dataset, the PI must sign an additional letter of commitment specifically related to datasets. Manuscripts resulting from these analyses are reviewed and approved by CIBMTR prior to submission to a journal.
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The first responsibility of the PI is to develop the study proposal into a comprehensive study protocol, with the help of invited Working Committee members. Study protocols are used by CIBMTR biostatisticians to prepare data files for analyses and define the detailed study design. This crucial document drives everything that happens once the study is accepted by the CIBMTR.
The protocol must include:
Once received by the CIBMTR Coordinating Center, the draft is further refined in collaboration with the Working Committee MS biostatistician, Statistical Director, Scientific Director and Chairs. A table with a preliminary description of the proposed population is added and the draft protocol is presented at a weekly Coordinating Center meeting.
Most studies will use data collected routinely, but in special cases where an important study cannot be done without supplemental data, collection of a minimal amount of additional data may be undertaken. If the study requires supplemental data collection (e.g. information not collected on CIBMTR Comprehensive Report Forms), development of a supplemental form will be required prior to approaching centers for that additional data. These forms are prepared by CIBMTR Coordinating staff in collaboration with the study PI and Committee Co-Chairs.
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The objective of study file preparation is to create a data file of eligible subjects who are consecutively treated at participating centers with adequate follow-up, with minimal missing data fields, and in large enough numbers to give the analysis sufficient statistical power to meet the stated study objectives. This process involves a series of steps by the MS biostatistician, sometimes working together with a Clinical Research Coordinator, to ensure data quality. It often involves consultation with the PI and the physicians and biostatisticians at the CIBMTR Coordinating Center.
These steps include finalizing:
Analyses proceed in several phases. The first analysis generally includes a detailed description of the patient population, univariate and multivariate analyses of study endpoints. These data are distributed to Writing Committee members, requesting their suggestions and comments. An iterative process then ensues. The PI works with CIBMTR Coordinating Center staff to summarize and discuss comments from the Writing Committee. Revised analyses, with a description of steps taken to address comments, are distributed to the Writing Committee. It is the responsibility of the PI to draft this memo with input from Coordinating Center staff. If additional substantive comments are made by the Writing Committee, the process is repeated until a final analysis is available. This final analysis serves as the basis for the manuscript.
The PI has primary responsibility for manuscript preparation and is expected to prepare a draft manuscript within 30 days of receipt of analysis results. This draft is then reviewed, revised as necessary, and approved by the Statistical Director and Scientific Director. They ensure that the description and interpretation of the statistical analyses are accurate, and they contribute to the fundamental message of the manuscript. The Coordinating Center then distributes the approved first draft to the Writing Committee and solicits feedback.
The PI incorporates relevant comments into a subsequent draft. As with the analysis, this is an iterative process until all involved agree that the manuscript is ready for submission. The approved final draft is the version submitted by the CIBMTR Coordinating Center to the appropriate peer-reviewed journal.
The final author list is determined at this stage since it depends on the value and extent of contribution of each individual throughout the study process. To assure co-authorship, members of the Writing Committee must make timely and substantive contributions to study design, data analysis, interpretation of results, and preparation of the manuscript for publication.
CIBMTR Coordinating Center staff are responsible for submission of the manuscript as well as any correspondence with the chosen journal. In most cases, the corresponding author is the Working Committee Scientific Director. The study MS-level Statistician forwards editor and reviewer comments to the PI, the Scientific Director and the Statistical Director. The PI is expected to prepare a response, if necessary, working with Coordinating Center staff, who will provide additional analyses of the data as needed. Communication with the journal, including re-submissions, is continued as necessary by Coordinating Center staff.
The following guidelines apply to studies that require samples from the Research Sample Repository (samples collected from related and unrelated transplant donors, cord blood units and recipients):