International Network of VENous Thromboembolism Clinical Research Networks

Study Endorsement

Rationale

Clinical studies, and especially randomized controlled trials (RCT), frequently require international collaboration and participation from multiple clinical centres 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. 

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

​Objective

INVENT’s study review and approval process is intended to identify high-quality studies that address important unanswered clinical questions about venous thromboembolism. The results of INVENT-endorsed studies should have the potential to lead to changes in clinical practice.

The formal review process provides a mechanism for INVENT Council Members to jointly determine which studies the network will promote and support.

​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 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 with the following documents to info@invent-vte.com:

  1. A completed INVENT Study Endorsement Application form
  2. A completed one-page structured study summary (as per suggested template)
  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.

​Review and Approval Process

  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. 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).
  5. INVENT Council will be given a minimum of 7 days to review before casting a vote.
  6. 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. Applicants 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.

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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