How to Propose a Study
CIBMTR supports investigators in conducting observational studies in hematopoeitic cell transplantation (HCT). Anyone willing to actively participate in the conduct of the study and follow the study development and management process may propose a study using the Study Proposal Outline.
Proposal preparation
Prior to submitting a proposal, we strongly encourage investigators to review:
- CIBMTR Data Collection Forms to familiarize yourself with data fields available in our database; supplementary data collection may be required if sufficient information is not already available.
- The list of already published works to review what has already been studied.
- The list of studies in progress to determine what is ongoing.
This assists you in identifying existing research variables and avoids duplication of works already accomplished or those in progress.
Proposal submission and review process
Step 1
The proposal is submitted to the CIBMTR Statistical Center at contactus@cibmtr.org. It is assigned a proposal number and distributed to the MS biostatistician and Scientific Director of the relevant Working Committee. Some studies are best conducted in joint fashion with two Working Committees.
Step 2
Statistical Center staff then reviews all proposals for scientific merit, feasibility, overlap with other studies, etc. If duplication is identified, the proponent may be asked to join the Writing Committee of an ongoing study.
Step 3
In advance of the February BMT Tandem Meetings, the Working Committee MS biostatistician prepares a table of characteristics of patient data based on the population defined in the proposal. This is used during the presentation at the Working Committee meeting.
Once cleared to move forward, the MS biostatistician contacts the investigator; all investigators are encouraged to personally present their proposals to the full Working Committee each February.
After presentation and discussion, Working Committee members vote for each proposal assigning a priority score to each.
NOTE: Most proposals will follow this path. However, rarely, a proposal deemed of high merit may be forwarded directly to the Working Committee for consideration during the year to be “fast tracked.”
Step 4
Working Committee leadership makes its recommendations, based on the priority score assigned to each proposal, their requirements for biostatistician time and allocation of resources within CIBMTR.
Step 5
Not all proposals can be advanced to the Working Committee for consideration. Those that do come before the Working Committee may be formally accepted and assigned a study number or may be designated as low priority and not accepted at this time.
NOTE: If the study requires biological samples from the NMDP Research Sample Repository, in addition to the review process described here, investigators must include a biosketch or brief curriculum vitae documenting experience in the laboratory methods proposed. The NMDP Institutional Review Board must also review proposed studies before samples can be distributed.
