Background

The Clinical Trial Roadmap is developed by DORP to optimally support investigator initiated clinical oncological research. It is not unique as most trial and science offices have their own guidelines. This roadmap is however the result of exchanging and combining experience and knowledge of experts from Erasmus MC, IKNL, LUMC, NKI-AvL, RadboudUMC, MUMC. It brings together useful tips, references and links to templates.

How to use

The Clinical Trial Roadmap guides investigators through 6 phases of a clinical trial. It gives an overview of responsibilities and of what needs to be organized. Importantly, at all times it should be used in conjunction with the investigator’s local institutional trial or science office.

Sponsor versus participating center

The activities differ for the initiating investigator (sponsor) and for participiating local investigators. Therefore two separate versions of the roadmap are available: one with to do’s for the sponsor and one with to do’s for participating centers. Each clinical trial phase is summarized by an infographic to illustrate the most important actions. By clicking on a phase in the general overview, the specified phase for the sponsor is entered. From there the corresponding phase for participating centers can be reached. Please note that an extensive full text version of the roadmap describing all actions more detailed is available on request via info@researchplatform-dorp.nl.

  • Phase 1

    Preparation

    Protocol and PIF are complete and ready to submit to MEC

    Feasibility and budget are clear

  • Phase 2

    Start up & initiation

    Study is ready to start because MEC and institutional board approval are arranged and logistics are ready

  • Phase 3

    Conduct

    Reach the endpoint defined in the protocol in a timely and safe manner

  • Phase 4

    Analysis & publication

    Analyse data according to the primary and secondary endpoints

    Publish the results

  • Phase 5

    Wrap up

    Trial termination

  • Phase 6

    Implementation

    Implementation of treatment or insights

    Start follow up research

    Investigator initiated phase 2-3 trials do not always provide the level of evidence needed to adjust guidelines, but can give indications for further research

Status

Phases 1-6 are available. The roadmap will be updated with information about the local feasibility procedure and VGO (Verklaring Geschiktheid Onderzoeksinstelling) in due time.

Questions or feedback

DORP is happy to come by to talk investigators and colleagues through the roadmap to facilitate trial start up. If you have feedback on the roadmap, let us know. Please contact DORP at info@researchplatform-dorp.nl.