Proposals for Clinical Trials & Ancillary Studies

Ancillary Studies and Secondary Data Analyses

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.

A secondary analysis uses previously collected data from BMT CTN studies to look at objectives other than those addressed in the original studies. Information about Network Ancillary Studies 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 a correlative research proposal, please submit the completed BMT CTN Correlative Study Proposal form by email to bmtctn_nmdp@nmdp.org.

Please note that research materials (biospecimens and 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

The BMT CTN supports investigators engaged in retrospective immunogenetic and immunobiological studies in Hematopoietic cell transplantation (HCT) / 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.