The commissioned workstream starts with a call for topic proposals or a request from governmental institutions. Selected topic proposals are translated into a commissioning brief. The commissioning briefs are published in a second call, inviting research teams to express their interest to perform the commissioned clinical trial by submitting a research outline.
The investigator-led workstream starts with a call for research teams to submit a research outline for research topics proposed by the research team itself. A research outline is a summary of a research project generally consisting of 3 elements.
1. a summary of the trial including the key information (PICO)
2. information on the feasibility of conducting the trial which covers both the expertise and infrastructure of the proposed sponsor and feasibility at clinical sites
3. a draft budget
The selection process consists of several steps, which are described below. Please note that the selection process for specific calls (e.g. international calls) may differ slightly but is always described in detail in the associated call text.
Step 1: Are topic proposals or research outlines valid?
When the deadline of a call is reached, the KCE Trials team checks if a submitted topic proposal or research outline fulfils the criteria related to a specific call, e.g. was the submission received before the deadline? Are essential data included in the submission?
Step 2: Do the topic proposals or research outlines fall within the scope of the KCE Trials programme?
In a second step, the KCE Trials team and the KCE Prioritisation Group (PG) judge if the proposals fall within the scope of the KCE Trials programme. KCE Trials focusses on comparative effectiveness research. Early phase development trials and implementation research are excluded from the programme. Each call can have additional specific criteria for its scope.
Step 3: Are topic proposals or research outlines important and relevant for the Belgian health care system?
When possible research topics are identified, they are reviewed and prioritised by KCE Trials in collaboration with a multidisciplinary panel of clinical professionals and representatives of patients and the public (the KCE Trials panels). The remit of KCE Trials panels is to answer the following two questions: “Is the research question important for clinical practice in Belgium?” and “Is it the right research question?” In addition, it is checked if potential research questions are not too similar to research already available or which is currently being carried out.
The final prioritisation of research questions is done by the KCE Trials Prioritisation Group (PG). The PG takes into consideration the comments of the Trials panel, the body of evidence already available, similar ongoing research, the overall KCE Trials portfolio and available budget.
Research topics received through the commissioned workstream, which are prioritised by the PG, are then published on the KCE website as commissioning briefs. Research teams that are candidates to perform a clinical trial to answer the research questions can submit their trial proposals.
Step 4: Are research proposals appropriate to answer the research question, scientifically and methodologically sound and feasible?
The KCE Trials Board reviews the research proposals for their methodological quality and scientific soundness. The board membership is made up from senior, experienced clinicians and methodologists (including triallists, statisticians and health economists) who are all active researchers in their field.
The board considers how well projects fulfil the following criteria when assessing proposals:
- How well does the proposal address the remit of KCE trials?
- What is the quality of the methodology and science presented?
- To what extent does the investigator and sponsor team possess the necessary skills mix and/or experience to perform the trial?
- Do the costs of the research represent good value for money?
- Is there a potential for efficiency savings for the health care system?
- Are the public and the patients involved throughout the study, from design until delivery, dissemination and implementation?
Research proposals submitted to the Trials Board will undergo a stepped selection procedure:
- Submission of an initial research outline by candidate investigators and sponsors with the key information on the proposed trial
- Submission of a full research proposal by the shortlisted candidate sponsor team for consideration by the Trials Board
This stepped approach facilitates a proportionate and timely assessment of the eligibility, feasibility and value for money of the research proposals which can progress to the second stage. Only shortlisted candidates will be invited and required to develop a FRP for further consideration and review by the Trials Board. A full research proposal contains all necessary information to assess the trial research proposal. Generally, it consists of 3 elements;
1. the trial detailed protocol
2. information on the feasibility of conducting the trial and
3. the final budget
The Trials Board can take the following decisions regarding the reviewed research outlines:
- Declined
- Declined and invited to submit a revised outline
- Shortlisted and invited to submit a FRP
For Full Research Proposals the following decisions can be taken by the Trials Board:
- Declined
- Declined and invited to submit a revised Full Research Proposal
- Recommended for funding, with or without changes
