General trial information
Trial proposals are introduced by hematologists in the relevant disease specific working group. During the working group meetings, the proposals are discussed and together it is determined to what extent the study proposal is in line with the current international scientific developments, patient interests and feasibility. After a positive decision, the principle investigator starts writing a first protocol draft.
Together with the CEO of HOVON, funding needs to be found. When funding is in place, the trial will be discussed with the HOVON board. A new trial receives a HOVON number after signing a start-up agreement or after the feasibility meeting between clinical operations and the principal investigator, whatever comes first.
Clinical Operations a trial will appoint a team that guides the development of the protocol and the operational aspects in order to start inclusion of patients. The study team is responsible for the central submission procedure, the development of the database and the logistic organization necessary for implementing the trial. The trial team does this in close collaboration with the Principal Investigator of the trial.
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 on the HOVON website [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
HOVON's goal is to have as much sites participating in a trial. Regretfully the budgets might form a limiting factor. Via a survey, we request hospitals to indicate if they are interested. 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 then financially feasible, an advice is requested from the committee Trials & Support taking into account the start-up times, the quality of the site and the geographical coverage (within the Netherlands). If you did not receive the survey and you do wish to participate, you can contact HOVON. HOVON will check if it is still possible to participate and if so, what is expected of you.
Like HOVON, there are also other hematological study groups operating in and outside Europe. Working together is increasingly important because trials have more often a focus on a limited group of patients with a specific disease. These collaborations are important to maintain a high accrual of patients in the trial and will ensure that treatment development moves on.
With these collaborations HOVON will not always be in the lead. These trials are indicated as intergroup trials. In these cases there is less opportunity to follow the HOVON procedures.
At section About HOVON, we provide policy documents who clarify this type of collaboration.
Since 2019 we have implemented a new study number system to distinguish between different types of trials:
- HO1XX: trials where HOVON performs the task of sponsor. The XX stands for the sequential number, e.g. HO156. This can continue upwards to HO499. Note: HO153 is the last intergroup study with HO1xx structure.
- HO5XX: trials where HOVON is a collaboration partner and another group is the sponsor (the so called intergroup studies), e.g. HO503. This can continue upwards to HO899.
- HO9XX: trials where HOVON is collecting data of the registration in a database for future research, e.g. HO902. This can continue upwards to HO999.
- SupHOXXX: for trials where an pharmaceutical company is the sponsor of the trial and HOVON provides support (Sup stands for support).
Registration of HOVON trials
HOVON registrates all her trials in acknowledged trial registry databases, like ClinicalTrials.gov. This is a Primary Registry acknowledged by WHO and ICMJE.