Selection criteria 2016 Commissioned workstream
The first selection of topics was based on general criteria. In addition, KCE has defined a set of specific criteria for each call. Trial proposals will be assessed based on the general and specific criteria.
1. Need for the Evidence
- The importance or burden of the health or care problem to those who would use the evidence generated by the proposed study
- What the proposed study would add to the existing body of knowledge
- Whether the study is likely to lead to improved health and care and effect practice change
- Whether the study would have a high impact on patients, the public and people working in health and care.
2. Value for Money
- The proposed costs of the research are reasonable and commensurate with the proposed work involved
- The costs to health and care services in supporting the research are reasonable in relation to the likely benefits of the research to decision-makers, patients and the public
3. Scientific Rigour
- The study design would answer the research question proposed
- The proposed study would be feasible and deliverable
- The team has the necessary skill mix and experience and project management of the study is sound
Specific, additional criteria for the 2016 Commissioned Workstream
1. The trial is a comparative effectiveness trial of interventions in use in Belgium, without limitation in terms of therapeutic domain or type of intervention or comparator.
2. A randomised design is preferred, and central randomisation procedures are highly preferred.
3. For data collection electronic CRFs are preferred, certainly in case of large pragmatic trials.
4. A multiple of the required number of patients is available in participating trial centres.
5. The trial will likely be completed within a three year period (first patient first visit to last patient last visit). The risk of recruitment delay is considered low.
6. The trial result can have an immediate and important impact on the efficiency of the healthcare system, preferably without the need for an additional implementation project.
7. The sponsor’s team has the necessary skills, procedures and experience in conducting non-commercial multicentre trials (see also in: ‘what is KCE trials?’)
8. Patient and public involvement: KCE strongly encourages patient involvement in research. The involvement of patients and public in the development of the project and their continued involvement through the lifecycle of the research project should be demonstrated.
9. The terms and conditions of the proposed collaboration between sponsor and KCE should be acceptable.