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The INVESTED Trial represents an opportunity to support the advancement of translational, clinical, and health services science related to influenza vaccination, outcomes research, and advancement in conduct of pragmatic clinical trials. 

 

The INVESTED Ancillary Sub-Studies Committee will consider proposals that make use of the trial dataset or samples collected. The types of proposals that will be considered include (but are not limited to): 

  • Mechanism of benefit from influenza vaccination in high risk cardiac patients

  • Conduct and analysis of a large pragmatic clinical trials 

  • Innovative methods to risk stratify and identify patients most likely to benefit from a strategy of high dose influenza vaccination

  • Other proposals of scientific merit related to INVESTED 

 

Eligibility Criteria

 

  • Scientific merit aligned with the aims of the overall INVESTED trial

  • Minimal study procedure-related burden to participants

  • Feasibility or lack of logistical barriers for the overall study conduct

  • Study activities limited to existing sites participating in the overall trial

  • Budget allocated for all costs that are in addition to the core study conduct and analysis (e.g. additional bioassay collection, processing, analyses, and storage)

  • Budget for support for the DCC for data analysis

  • Budget for support for the CCC for additional substudy management and site coordination logistics to participate in the substudy

 

Review Process and Evaluation

 

Applications will undergo an initial assessment by the INVESTED Ancillary Sub-Studies Committee to ensure relevance to the INVESTED trial mandate and/or priority areas prior to progression to full review.  Studies meeting eligibility criteria will be evaluated by the trial Executive Committee based on:

  • The relevance of the substudy aims and strength of the substudy team

  • The extent to which the substudy proposal contributes to the advancement of the field and is aligned with the priorities of the overall trial objectives

  • The novelty and feasibility of the substudy aims, methodology, and procedures

  • The overall strength and clarity of the proposal

 

Funding

 

Applications to all potential sources of funding are encouraged (including Federal, Foundation, Association, or Industry).

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For more information or proposal submissions please contact

INVESTED Trial Ancillary Sub-Studies Committee Co-Chairs: 

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Orly Vardeny, PharmD, MS, ovardeny@umn.edu,

Jacob Udell, MD, MPH, jay.udell@utoronto.ca

Ancillary Studies

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