Content - Project submission

How to submit a project at SAKK

The core task of SAKK is to conduct clinical cancer research (see our research strategy). We encourage interested researchers who want to engage and collaborate with us to submit their project proposals.

How to submit a project at SAKK

Preparation phase

You first discuss your idea within one of our SAKK research groups and then prepare the proposal that is reviewed by the SAKK proposal review committee (PRC) before submitting to the board.

  • 1 Reach a consensus

    Researchers in the SAKK network regularly exchange scientific knowledge and findings in indication-specific project groups, working groups and specialty sections. Trial proposals are initiated and discussed at these expert meetings, then developed further before presented to pharmaceutical companies for support and collaboration, and to the SAKK board for assessment.

    Details on how and when to prepare your proposal documents can be found in the third drop-down menu “Submit your proposal to the Concept Review (CR) / Proposal Review Committee (PRC)”.

    Before submitting your proposal to the board you need to find a consensus in your research group and comply with the following conditions:

    • The trial proposal must be discussed in and approved by the submitting SAKK research group (see SAKK regulations of project groups).
    • In case of a interdisciplinary study proposal, an additional review by the respective SAKK research group is required. For this purpose the coordinating investigator of the submitting group shall contact the president of the reviewing group.
    • If one of the following disciplines is additionally involved in your study proposal, a review of the corresponding SAKK research group is required:
    •  

    The intended application to the board, including the result of the anonymous vote, must be clearly stated in the minutes of the SAKK research group meeting. Initial contacts to pharmaceutical companies may be established by the designated coordinating investigator, but formal submissions and negotiations (e.g. for support in terms of drug supply and additional financing) should only be done after prior discussion with the responsible person at the SAKK Coordinating Center and possibly the SAKK president.

    Please find here more details about the meeting dates and contact person of each of the SAKK research groups.

  • 2 Prepare your proposal

    • SAKK trial

      For initial assessment the coordinating investigator has to provide the following documents:

       

      In case of initial re-assessment only:

      • All conditions from previous discussions in the board are fulfilled or non compliance is explained.

       

      The complete documentation has to be sent six weeks prior to a SAKK board meeting to proposals@anti-cluttersakk.ch. In case of questions please contact the responsible person at the SAKK Coordinating Center.

    • Trial of cooperative groups

      For initial assessment the coordinating investigator has to provide the following documents:

      • Protocol or trial synopsis of the cooperative group
      • Trial synopsis of the cooperative group discussed in and approved (written vote) by the submitting SAKK research group (project group or section or working group) for initial assessment and stated in SAKK research groups’ minutes.
      • In case of interdisciplinary study the trial proposal has also been discussed by the respective SAKK research group.
      • Completed list of participating sites and committed accrual.
      • Completed and signed Conflict of Interest Policy
      • 4-5 important publications relevant to the proposed project (please be aware that we need references for the assumption concerning the primary endpoint)
      • Ideas of financing

       

      In case of initial re-assessment only:

      • All conditions from previous discussions in the board are fulfilled or non compliance is explained.

       

      The complete documentation has to be sent six weeks prior to a SAKK board meeting to proposals@anti-cluttersakk.ch. In case of questions please contact

      SAKK_responsible_persons_at_SAKKCC_20170919.pdf: Due to unknown reasons the file could not be opened.

    • Translational research project

      Translational Research Projects (TRP) need to be discussed with the coordinating investigator of the trial and the president of the respective project group.

      Translational research projects are submitted by the coordinating investigator directly to final assessment.

      For final assessment the coordinating investigator has to provide the following documents:

      • Completed SAKK Translational Research Proposal Form discussed with the coordinating investigator and the group president
      • Completed and signed Conflict of Interest Policy
      • 4-5 important publications relevant to the proposed project
      • Ideas how to finance the subproject (be aware that SAKK will help in submission of grants, but will not provide funding for Translational Research Projects)

       

      Details of the budget and suggestions for the compensation for the participating sites (if applicable) is provided by the responsible person at the SAKK Coordinating Center and discussed with the coordinating investigator before submission to the board.

       

      In case of final re-assessment only:

      • All conditions from previous discussions in the board are fulfilled or non compliance is explained.

       

      The complete documentation has to be sent six weeks prior to a SAKK board meeting to proposals@anti-cluttersakk.ch. In case of questions please contact the responsible person at the SAKK Coordinating Center.

    • Other projects

      SAKK also supports non-interventional clinical research projects, such as cohort study, registry study, retrospective data collection, outcomes research and healthcare research.

      For more information about the submission process for non-interventional clinical research projects, please contact the responsible person at the SAKK Coordinating Center or send an email to proposals@anti-cluttersakk.ch.

  • 3 Submit your proposal to the Concept Review (CR)/Proposal Review Committee (PRC)

    Step 1: Before or directly after having discussed the proposal for a new SAKK trial for the first time in the group, you are encouraged to submit a Core Trial Proposal Form (Core TPF) together with the 3-4 most important papers (supporting the primary endpoint) for a Concept Review (CR) at the SAKK CC. The documents for the Concept Review (CR) can be sent at any time, but if the proposal is to be discussed at the next group meeting, the documents have to be submitted at least three weeks prior to the next PG/WG/S meeting to the responsible person at the SAKK Coordinating Center.

    Within ten working days after confirmation of receipt of your documents, the CR Committee will advise on trial methodology and statistical parameters (design, rationale, objectives and sample size) and, if requested, prepare a first budget.

    Step 2: After having discussed and agreed on the project in the group, the coordinating investigator or the responsible person at the SAKK Coordinating Center collects the sites’ commitment of participation, including the estimated accrual per year.

    The complete documentation for the assessment by the SAKK board has to be sent six weeks prior to a board meeting to the responsible person at the SAKK Coordinating Center. Within seven days after confirmation of receipt of your documents, a formal check will take place ensuring the completeness of the documentation.

    The Proposal Review Committee (PRC) will have a final look at the documents provided. The focus this time lies on feasibility, both accrual and funding, and on the implementation of the advice given during the CR.

    If the documents provided to the SAKK Coordinating Center are not considered "final" due to open essential questions, the PRC may decide to postpone the submission of the proposal to the SAKK board.

    If necessary due to an exceptionally high number of submitted proposals to the board, the SAKK president, together with the SAKK CEO, might set an overall cap of the number of proposals that are manageable in view of the limited time frame of a regular board session. In these cases, the principle "first come, first served" will be applied to complete submission packages received at the SAKK Coordinating Center.

Evaluation phase

In case your proposal documents provided to the SAKK Coordinating Center are considered as final and approved by the project review committee, your proposal will be presented to the board for approval.

  • 4 Initial assessment

    In the initial assessment the SAKK board evaluates the project with regards to its scientific relevance, feasibility and conformity to SAKK strategy. The evaluation is summarized in the following articles of the SAKK organizational regulations of the board:

    • Art. 12 (approval process)
    • Art. 13 (rejection of trial or subprojects)
    • Art. 14 (international reviewers)

     

    You will receive an oral feedback immediately after the meeting if present and a written feedback 14 days after the meeting at the latest. The SAKK board either rejects the project, sends the proposal back to the SAKK research group with recommendations or accepts the proposal to proceed for final assessment straight away.

  • 5 International review

    Once the proposal has been accepted in the initial assessment, the responsible person at the SAKK Coordinating Center forwards the proposal for reviewing to international experts, asking them to judge the proposal’s originality, methodology, feasibility and priority.

    The SAKK Coordinating Center estimates the resources needed to conduct the trial, establishes a trial-specific budget and suggests a patient fee.

    The SAKK Coordinating Center liaises with pharmaceutical companies and starts negotiating and developing trial-specific contracts (drug supply; funding), where applicable.

  • 6 Final assessment

    In the final assessment the SAKK board takes a final vote on the proposal, taking into consideration the international experts’ opinion, budget (incl. decision on the amount of the patient fee), external financial support and available resources.

    For final assessment the coordinating investigator has to provide the following documents:

    • Conditions of the board from previous assessments are fulfilled
    • Revised SAKK Trial Proposal Form (if required)
    • Updated/revised list of participating sites and committed accrual (if required)
    • Written commitment for financing (letter of intent from companies)
    • Written commitment for guaranteeing drug/device supply (if applicable)
    • Statement to comments of international reviewers (if required)

     

    Details of the budget and suggestions for the compensation for the participating sites (if applicable) is provided by the responsible person at SAKK Coordinating Center and discussed with the coordinating investigator before submission to the board.

    The complete documentation has to be sent two weeks prior to a SAKK board meeting to proposals@anti-cluttersakk.ch. In case of questions please contact the responsible person at SAKK Coordinating Center.

Fast track submission: 2 steps in 1 board meeting

A time-sensitive project that is 100% financed with available reviews of the international assessors and strategic collaborations (IBCSG, IELSG, ETOP trials) and some other projects after consultation with the Head of Clinical Project Management / Head of Innovation & Development can be submitted for initial assessment and final assessment during the same board session.