International Network of VENous Thromboembolism Clinical Research Networks

Dragons’ Den Competition

 

Rationale

Clinical studies, and especially randomized controlled trials (RCT), frequently require international collaboration and participation from multiple clinical centers to meet sample size requirements in a timely manner. Conducting clinical research in multiple countries offers the advantages of faster participant recruitment and study completion, and greater generalizability of results. 

INVENT aspires to be the international driver and accelerator for patient-oriented, investigator-initiated clinical venous thromboembolism (VTE) research and aims to be the key facilitator for international collaboration among VTE clinical investigators.

​Competition

INVENT will be hosting the 2021 Dragons' Den Competition - a virtual, public competition for INVENT Study Endorsement & Funding to be held on July 8,  2021 - 16:00-17:00 UTC / GMT.

One endorsed study will be offered a $40,000 (CAD) International Collaboration grant. A $20,000 (CAD) grant will be awarded to the second highest rated application.

Dragons’ Den Session 2021

  • Date: Thursday, July 8, 2021
  • Time: 16:00-17:00 UTC / GMT
  • Location: Virtual , live broadcasted event!
  • Program: Available once applicants are selected

Applicants will be invited (see ‘Eligibility’ and ‘Application Process’ below) to present a proposal of their research study to potentially be endorsed by the INVENT Network and/or be awarded an International Collaboration grant. Each applicant will have 5 minutes to present their proposal. After each presentation, the presenter will be probed by three INVENT Dragons with pointed questions geared towards determining if the proposed study is well designed, feasible, and will be practice-changing. Simultaneously, the audience, using an interactive polling system, will rate each proposed study on its potential to change practice. After the final presentation, the audience will be asked to vote for the project that is most likely to change practice.

​Eligibility

Applicants: The proposed study must be supported/developed by members of two or more national VTE research network members of INVENT. Applicants must be committed to international collaboration, ethical research practices, and fair recognition of co-investigators’ research contributions.

Study stage: Research at any stage of development is eligible for endorsement by the INVENT Network. Investigators may apply for approval of a preliminary protocol, a study with a fully developed protocol, or one that is actively recruiting participants.

Research design: Academically-driven clinical research studies that are seeking to recruit participants in multiple countries must be one of the following designs:

  1. Randomized controlled trial (RCT) or a pilot trial to inform an RCT;
  2. Quasi-experimental (non-randomized) study evaluating a treatment, intervention, management strategy or diagnostic strategy. Participants in one or more groups are managed uniformly as prescribed by the protocol, with a specific hypothesis, e.g. “risk of recurrent VTE will be less than 2% over 90 days if using this strategy”.

Competing studies: Ideally, the proposed study is unique and does not replicate or compete with an ongoing study. Applicants are expected to make efforts to identify other studies that are in progress that are seeking to answer the same or a similar research question. Justification for undertaking a similar study must be provided.

​Application Process

The applicant sends an application package consisting of the following documents:

  1. A completed INVENT Study Endorsement Application form ( call for proposals package)
  2. A completed one-page structured study summary ( call for proposals package)
  3. Full study protocol (in whatever form is available at time of application)[1]
  4. A letter or e-mail from the Applicant’s National Network indicating national support for the study.

[1]If only a preliminary proposal is being submitted for consideration, it is not necessary to submit a full protocol.

​Study Endorsement

All studies presented at the Dragons’ Den competition will be subjected to the INVENT study approval process intended to identify studies that align with the Network’s aspirations and which the Network will endorse. The formal review process (see ‘Review and Approval Process for Study Endorsement’ below) provides a mechanism for INVENT Council Members to jointly determine which applicants will be invited to participate in the Dragons’ Den competition, and which studies the network will eventually promote and support, as well as select for the competition prizes.

​Review & Approval Process for Study Endorsement

  1. The INVENT Staff and Chair conduct an initial review for completeness, clarity, and eligibility.
    1. The proposal may be sent back to proponents for refinement/comments/questions prior to review and endorsement.
  2. Upon approval by the Chair, the INVENT Staff circulates the application via email to two main reviewers.
    1. Both reviewers will complete the INVENT study endorsement evaluation form.
    2. The first reviewer should provide a thorough critique of the study and may review the full protocol if they judge it to be necessary to have complete understanding of the study.
    3. The secondary reviewer may provide additional comments and critique to the first reviewer’s evaluation.
  3. Once the main reviewers have completed their evaluations, based on mean review scores (cut-off is 7 out of 10), the application will either be rejected or be circulated to the full Council with the study summaries for review and commentary (if any).
  4. Eligible applicants may be invited to present at the Dragons’ Den competition. INVENT reserves the right to limit the number of applicants that will be invited to participate in the Dragons’ Den event and hence be eligible for the International Collaboration grant. However, all complete and eligible proposals will be considered for INVENT endorsement.
  5. At an INVENT Council Meeting to follow the Dragons’ Den competition, a full Council vote will be conducted to establish support for the study and approval for endorsement. The vote may occur at an INVENT Council Meeting (teleconference or in-person) or votes may be cast electronically (e.g. by email response or digital poll). The top ranked study will be offered a single $40,000 International Collaboration prize. The second highest rated study will be offered a $20,000 prize.
  6. INVENT Council will be given a minimum of 7 days to review before casting a vote.
  7. All Council members may vote, in-person, by electronic means, or by proxy, to approve a study, regardless of their involvement or interest in the study. For the voting process, quorum is 30% (in-person or by proxy) and a majority vote in one where more than half of the members of Council present and voting vote in the affirmative.

Post-Approval Procedures

  1. Applicant requesting approval of a research idea or preliminary proposal are expected to provide additional study details once the proposal is developed. Studies that have already received approval will not require formal review again.
  2. If a pilot study is endorsed by INVENT, the subsequent full study/trial of a similar design will not require formal review by Council. A structured summary describing the full study (as per template) is to be submitted by the principal investigator to info@invent-vte.com. The Chair or Vice-Chair will confirm INVENT’s endorsement of the full trial.
  3. INVENT support is to be acknowledged in publications and presentations as follows: The International Network of Venous Thromboembolism Clinical Research Networks (INVENT) endorsed and supported this study.

​INVENT Support of Endorsed Studies

  1. A letter of endorsement will be provided (upon request, the letter may be tailored to include in a funding application, etc.).
  2. A study summary will be posted on the INVENT website (lay summary encouraged).
  3. The study will be promoted to members via e-mail and social media platforms.
  4. Endorsed studies will have access to INVENT resources, e.g. use of adjudication platform at “academic rate.”
  5. INVENT Council Members will actively promote endorsed studies within their national networks.

​Competition & Study Endorsement Application

Submission instructions: Please open the .PDF file using Adobe - not in your browser. If you are unable to submit the form, please manually save and send your completed application to info@invent-vte.com or simply use the word version available for download.

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