The MTN accepts concepts for new protocols from all interested parties in the belief that the best clinical research program is one that is both enabling and receptive to new ideas and capable of maintaining a timeline-driven protocol development and implementation process. Concepts arise from a variety of sources, and MTN reviews all study concepts that are submitted for consideration.
Ancillary Studies are defined as investigations that are not described in the original protocol and that require additional data collection or laboratory sample analyses to be performed. Ancillary Studies can be either retrospective or prospective in nature. Examples of Ancillary Studies include studies that require analyses of biological specimens, collection of additional specimens, administration of behavioral surveys, conduct of focus group discussions, etc.
Secondary Data Analyses are analyses, different from those performed for the protocol objectives, which are requested by an investigator to write an abstract, manuscript or other scientific publication, and/or to present at a meeting or conference. Secondary data analyses may be requested while a study is ongoing, or after follow-up or closeout has been completed. They are retrospective in nature, involving data previously collected as part of an MTN trial but not requiring additional procedures or analyses of specimens. These may include site-specific data analyses. Secondary Data Analyses may require additional statistical support.
Requests for datasets are occasionally made by researchers conducting their own investigations (usually for PhD dissertations). These requests for datasets must be approved.