Acarbose Cardiovascular Evaluation
Ancillary Study Proposals
The Steering Committee for the Acarbose Cardiovascular Evaluation (ACE) trial accepts ancillary study proposals for review. These can provide valuable information beyond that explored in the context of the main trial, and will promote continued academic interest in the ACE trial.
We define an ancillary study as an investigation that is distinct from the ACE main protocol, but uses information from ACE participants, data, or samples collected by ACE. Such studies may involve the acquisition of data not obtained as part of the ACE study procedures, and may utilize information from some or all of the ACE participants.
All Ancillary studies, and any proposals for biomarker or genetic analyses, require external funding which must include provision for any ancillary study costs. In order to protect the integrity of the ACE trial, ancillary study proposals must be reviewed and approved by the ACE Steering Committee prior to their submission for funding. Studies that propose to analyse ACE data for novel study questions not included under the scientific aims of ACE can also be considered as ancillary studies.
Please note the following specifications as you consider submitting an ancillary study proposal:
- All ACE ancillary studies require external funding, as the ACE trial budget cannot finance additional investigations.
- At least one ACE 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 ACE data may not be available to investigators of ancillary studies prior to the completion of the main study.
- Treatment group assignment will not be unblinded until completion of the main trial.
- As with all clinical trials conducted in China, samples collected can only be processed and analysed in accredited laboratories in China and cannot be exported for analysis out of the country
- Please refer to the ACE Ancillary Studies Policy for further details.
To submit an ancillary ancillary study proposal, please complete an Ancillary Study Application Form
. Participation of the specified ACE investigator will be confirmed prior to official review. Please be certain that your contact information is correct, as additional information may be requested of you during the review process. We appreciate your interest in the ACE Study, and look forward to receiving your proposal.