Science Platforms

CanVECTOR Pilot Trials Funding 2018

Background

We are pleased to announce the third call for proposals for CanVECTOR Pilot Trials Funding. The Canadian Venous ThromboEmbolism Clinical Trials and Outcomes Research (CanVECTOR) Network is a pan-Canadian, patient-oriented Community Development Program centered on Venous Thromboembolism-related research, training, and knowledge translation. Our mission is to decrease the health, social and economic burden of venous thromboembolism (VTE) on affected individuals, their families, and on Canadians as a whole. The purpose of this funding opportunity is to build research capacity related to VTE and to enable CanVECTOR scientists to collect pilot data that will inform the conduct of larger multicentre clinical trials and increase the ability to attract external peer-reviewed funding.

Funding Details

A total of $100,000 is available to fund one or more pilot studies between October 2018 and September 2020 (CanVECTOR Years 4 and 5).  Funding for individual projects may be awarded over one or two years.

It is expected that the applicants will seek peer-reviewed funding for the full trial within 3 years of receiving CanVECTOR funds.

Eligibility

Applicants

  • The project team for the pilot study will include an investigator triad (senior investigator, an early or mid-career investigator, and a thrombosis fellow or trainee).  It is also expected that a methods expert will be included on the team.
  • At least one of the investigators in the triad must be a CanVECTOR member. 
  • Any investigator in the triad can be the lead investigator for the application. 
  • Inclusion of investigators from less-established research sites is encouraged.
  • CanVECTOR is committed to conducting research that is meaningful to patients and their families and to including trained patient partners on project teams. Applications should include a patient engagement strategy and/or patient partner. To request assistance, please contact the co-leads of the Patient Partners Platform: Lisa Duffett (lduffett@toh.ca) or Jessica Emed (jessica.emed@mcgill.ca).

Projects

  • The project is expected to collect pilot data at two or more sites to inform a randomized controlled trial (RCT) that will be conducted at multiple CanVECTOR sites. Though it is often considered preferable, it is not an absolute requirement for the pilot study to have an RCT design; for example, it can be a cohort study that’s collecting pilot data that is needed to design a full RCT.
  • The pilot project must be completed within two years.
  • The research focus is to be related to prevention, diagnosis, or treatment of venous thromboembolism or its sequelae.
  • Applicants are encouraged to refer to the following online resources (open access) that outline methodology and best practices for pilot studies

    CONSORT 2010 statement: extension to randomised pilot and feasibility trials

    http://www.consort-statement.org/extensions/overview/pilotandfeasibility

    A tutorial on pilot studies: the what, why and how

    http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-10-1

Pilot Project Application Requirements

Deadline

All applications must be received no later than February 28, 2018.

Please send completed applications to Trials@canvector.ca

Format

The Pilot Proposal should be no more than 4 pages (single-spaced, size 11 Arial font, 1 inch margins), excluding references.  Additional appendices may NOT be included.

One electronic (PDF) copy of the application is required that includes the: 1) Application Form, 2) Pilot Proposal, and 3) Budget.

Submission Requirements

  1. Application form (2 pages)

    The application form can be downloaded at this link: Download Application Form.

  2. Pilot proposal - recommended content (maximum 4 pages)
    • Study overview (1 paragraph)
    • Background and rationale
    • Research question(s) and specific aims
    • Significance and novelty of research question(s)
    • Description of the investigator team
    • Study design
    • Study population and sample size
    • Intervention studied (if applicable)
    • Measurement of outcomes
    • Planned analyses
    • Description of any potential ethical issues and how these will be addressed
    • Description of the next steps: Indicate how the pilot project will facilitate the development of a full scale research proposal. Indicate the funding agencies to which the full project will eventually be submitted
    • Detailed timeline for each specific aim (Note: Pilot projects must be completed within 2 years of receiving funds)
  3. Budget and budget justification (maximum 2 pages: spreadsheet + justification)

    Budget items must specifically relate to the pilot project, and may include:

    • Costs of research personnel salaries (e.g. research assistants, study coordinators, technicians, programmers, statisticians) and benefits (specify cost of study personnel at study sites)
    • Supplies and expendables
    • Equipment (carefully justified, with cost quotations provided)
    • Participant costs (e.g. reimbursement for hospital parking)
    • Patient partner costs (e.g. honorarium, reimbursement for transportation)
    • Presentation/Publication (to a maximum of $1500)

    Ineligible Expenses:

    • Institutional or administrative overhead (any indirect costs)
    • Salary support for investigators or trainees
    • Meals, alcohol, employee recognition

    The applicant must state in the Budget if part of the Pilot Study will be funded from another source, and justify the other source(s) of funding.

Review Process and Evaluation Criteria

  • Applications must be submitted by email to trials@canvector.ca by the end of day February 28, 2018.  Incomplete or late submissions will not be considered.
  • Proposals will be reviewed by an internal CanVECTOR committee consisting of the co-chairs of the Pilot Trials Platform (Dr. Clive Kearon and Dr. Gregoire Le Gal) and a minimum of 4 additional reviewers, including CanVECTOR members and international thrombosis experts.  The committee will make recommendations for funding.
  • Decisions will be announced by April 15, 2018.  A letter of notification including brief feedback from the review committee will be sent to all lead applicants.
  • Funds will be released to the lead investigator’s institution as soon as the required paperwork is completed.

Rating System: A 10-point rating system will be used by the reviewers:

Component Maximum Points

 The research team

(investigator triad, methods expert, patient engagement, inclusion of investigators at less established research sites) 
 2

The research proposal 

(including relevance to CanVECTOR's mission)
Feasibility of the pilot trial and the full RCT 

Administration and Conditions of Funding

  • A summary of the successful pilot proposal will be posted on the CanVECTOR website.
  • Registration of the pilot trial in a clinical trials registry (e.g. Clinicaltrials.gov) is required.
  • Funds will only be released once evidence of Research Ethics Board approval is provided by the lead investigator.
  • Funds will be released to the lead investigator’s institution on an annual basis.  The name of the institution’s financial officer must be provided to CanVECTOR’s Financial Officer.
  • Use of funds must comply with CIHR guidelines and those outlined in the Tri-Agency Financial Administration Guide (2015) (http://www.nserc-crsng.gc.ca/Professors-Professeurs/FinancialAdminGuide-GuideAdminFinancier/index_eng.asp ).
  • Successful applicants will complete a 1-page progress report after 1 year of receipt of funding, and a 1-2 page final report within 3 months after the 2nd year of funding is completed (if applicable).
  • The funding recipient shall immediately notify CanVECTOR of his/her inability to complete the pilot project for any reason.  In this case, any unused funding will be returned to the CanVECTOR Financial Office, and used funds must be justified or repaid.
  • If the one-year progress report has not been submitted, or if progress of a 2-year project is deemed unsatisfactory, any unused funding will be returned to the CanVECTOR Financial Office and funding for the second year will not be released.
  • The recipients of CanVECTOR pilot trial funding will be expected to present their proposal and results at CanVECTOR annual meetings. Additional knowledge translation activities are encouraged, regardless of the pilot trial’s results.
  • CanVECTOR and CIHR funding must be acknowledged in any publication or presentation arising from the pilot trial (see Policy on acknowledgement of CanVECTOR in publications and presentations).