General trial information
Proposals for new trials are submitted by researchers in the relevant working group. During the working group meetings, the various proposals are discussed. A determination is made of the extent to which the trial proposal ties in with the multiyear planning and whether there is sufficient interest within the working group to elaborate the proposal in question. If this is the case, within the working group a start is made on elaborating the idea into a draft protocol.
The chairperson of the working group submits the proposal to the HOVON board, with an indication of the priority in respect of other trial proposals from their own working group. It is then up to the HOVON board to decide whether the proposal can be formed into a definitive protocol and there will be a feasibility meeting set up with the HOVON Data Center (HDC).
If the HOVON board gives the green light for the proposal, they notify the HDC. A trial team is then formed. The HDC then starts developing the protocol and trial documents. The HDC is then responsible for the central submission procedure and the administration and logistic organization necessary for implementing the trial. The HDC does this in collaboration with the with the appointed Principal Investigator.
Please find the templates for the Trial Proposal Form to announce a new trial and HOVON protocol and ICF templates at the trial start-up section after logging in [General trial information > Trial start-up > Trial start-up documents]
Within the HOVON, trials are implemented according to the EU Directives and the GCP guidelines.
Participating in a trial
During the trial set up, HOVON sets up a budget for the amount of countries and hospitals (also called sites) that can participate. This will be negotiated with the funder. HOVON always tries to have as much sites participating as is feasible. Via a survey, we request hospitals to indicate if they are interested to participate. These surveys are always send out to the site contact person (as shown in the site details (section hospitals > contact details after log in), and trial coordinators (when known).If there are more sites willing to participate, it is decided by the PI and the working group (and based on geographics) which sites will be invited. If you missed the survey or subsequently decide you do wish to participate, you can contact the HDC. The HDC can check if there is still room for extra sites and will inform you what is expected of you. The HDC will also make sure that you receive the necessary documents, vital for local submission.
As well as the HOVON, there are a number of other hematological study groups operating in Europe and it is increasingly common for the various study groups to work together in order to increase the speed of inclusion. If several HOVON sites indicate a wish to participate in an international trial of this kind, the HOVON will initiate discussions with the sponsor to see if a collaboration is possible.
In this construction, the HOVON sites participates in a collaboration trial. In these cases it can be that there is less possibility to adhere to HOVON templates and HOVON procedures, as the sponsor has the final responsibility on running the trial. Of course HOVON will do its best to adhere to our own standards as much as is possible and accepted by the sponsor.
At section About HOVON, we also have a policy documents that provides more information in the collaboration in international trials.
Registration of HOVON trials
HOVON registrates all her trials in acknowledged trial registry databases. This can either be the Nederlands Trialregister (Dutch Trial Registry, NTR). This is a Primary Registry acknowledged by WHO and ICMJE. Or in the international orientated ClinicalTrials.gov.