Proposals for Clinical Trials & Ancillary Studies

Ancillary Studies: Leveraging Existing BMT CTN Research Materials

An ancillary study entails the collection from study participants of data and/or specimens, or the conduct of additional analyses of existing materials or samples that are outside the specific objectives of the primary study. Information about Network ancillary studies can be found in the Manual of Procedures, Chapter 11; a summary of the ancillary study review and approval process is also available.

Correlative studies leverage samples collected during the primary Network trial; the BMT CTN supports correlative studies using samples collected from the trials listed below (‘BMT CTN Research Sample Collections for Correlative Studies’). Donor and/or recipient baseline samples corresponding to patients enrolled on BMT CTN trials are also often available from the CIBMTR Biorepository and may be requested together with BMT CTN samples using this single, convenient proposal mechanism.

A secondary data analysis uses previously collected data from BMT CTN studies to look at objectives other than those addressed in the original studies. These ancillary studies are distinct from correlative studies as they do not require the use of samples. Information about secondary data analyses can be found in the Manual of Procedures, Chapter 12.

To assist in study planning, a demographic characteristic summary of each closed BMT CTN trial cohort is available.

To submit an ancillary study research proposal (correlative or secondary data analysis), please complete the the BMT CTN Ancillary Study Proposal form and return it by email to bmtctn_nmdp@nmdp.org.

Please note that research materials (biospecimens and/or clinical data) will only be provided following proposal approval by the BMT CTN Executive Committee. Additional information may be found in the Manual of Procedures.

BMT CTN Research Sample Collections for Correlative Studies

The BMT CTN supports investigators engaged in retrospective immunogenetic and immunobiological studies in hematopoietic cell transplantation (HCT)and Cellular Therapy (CT) by providing access to numerous research samples and clinical data collected during our BMT CTN clinical trials. Protocol-specific links provide investigators with the following resources:

• Clinical protocols to review primary and secondary endpoints and other relevant clinical data collected in each trial.
• Information regarding the prospective collection schedule for research samples, sample processing, and sample storage parameters.
• Protocol-specific research sample collection summaries to facilitate initial assessments of available research samples for future ancillary study planning.
• Overview of BMT CTN procedures for reviewing and approving ancillary study proposals and current proposal submission form.

Ancillary study proposal form

Questions about ancillary studies may be directed to bmtctn_nmdp@nmdp.org.