Ancillary studies

Ancillary Study Proposals

The Executive Committee for the Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin (TECOS) will accept ancillary study proposals for review. Ancillary studies may provide valuable information beyond that explored in the context of the main trial, and will promote continued academic interest in TECOS. We define an ancillary study as an investigation that is distinct from the TECOS main protocol, but uses information from TECOS participants, data, or samples collected by TECOS. Such studies may involve the acquisition of data not obtained as part of the TECOS study procedures, and may utilize information from some or all of the TECOS participants.

Please note the following specifications as you consider the submission of an ancillary study proposal:

• All TECOS ancillary studies will require outside funding, as this pragmatic trial cannot finance additional investigations.
• At least one TECOS investigator must be involved in each proposed study, either as an initiating investigator or a collaborator.
• Proposed studies must not have a deleterious impact on the main study, particularly with respect to interventions which might confound the main study objectives.
• Ancillary studies should not significantly increase the time and effort required of patients or site personnel. This may preclude studies involving detailed data collection, unless they involve only a small number of sites.
• Primary TECOS data will not be available to investigators of ancillary studies prior to the completion of the study. In addition, treatment group assignment will not be unblinded until completion of the main trial.

All received ancillary study proposals will undergo an initial review by the TECOS Ancillary Studies Committee. That committee may recommend advancement of the proposal to the Executive Committee for further evaluation; request revisions of the proposed study; or reject the submission.

All ancillary studies must be reviewed and approved by the TECOS Executive Committee prior to initiation. Studies which request access to the biomarker/future use blood samples will require additional review and approval by the Biomarker Committee.

To submit an ancillary study proposal, please complete this Ancillary Study Application Form

TECOS Study, Diabetes Trials Unit, OCDEM, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LJ
Tel: +44 (0)1865 857260     Fax: +44 (0)1865 857246     Email: tecos@dtu.ox.ac.uk

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