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  • Clinical Trial Units (CTUs) in Belgium

    Within the framework of the KCE Trials Programme, KCE will select and fund trials but will not conduct them. A call for expression of interest or submission of a research outline is published on the KCE website and potential sponsors can submit their application. The role of the trial sponsor (the person or organisation who takes responsibility for the initiation and management of the trial) is taken by a hospital or institution that is qualified to be a sponsor of non-commercial clinical research according to the Law of May 7th, 2004 on experiments on the human person.

    The sponsor needs to be compliant with all applicable legislation and perform the sponsor responsibilities in section 5 of ICH-GCP. KCE Trials believes that it is important that the trial oversight is done in a centralised way. Therefore the involvement of a Clinical Trial Unit is considered a key element to obtain robust high quality trial results.

    Although Belgium has a long history of excellent clinical research, the conduct of large, non-commercial, multi-centre, randomised, pragmatic clinical trials is fairly new. Data on available sponsor capabilities and capacity is lacking for the Belgian University Hospital landscape. Therefore KCE Trials decided to perform a gap analysis at the different potential candidate sponsor sites in Belgium that had established experience in running randomised multicentre trials. For this, a CRO was selected by public tender. Each gap analysis was conducted during a 2-day visit performed by an independent Quality Manager and a KCE-representative as observer.

    In a first round, the 7 university hospitals were visited. The scope and focus of the visits was compliance with ICH-GCP and ISO 9001, in particular the sponsor processes necessary to be able to initiate, execute, manage and oversee multi-centre, randomised, pragmatic, comparative effectiveness studies. Processes reviewed were, including but not limited to:

    • Overall Management System
    • Selection of sponsor staff involved in the management and oversight of study conduct and relevant training
    • Document Management Processes
    • Quality Processes
    • Study design, performance, analysis and reporting
    • Site Selection and Oversight Process
    • Contracting, Sub-contracting Process and vendor management
    • IMP management and accountability Process
    • Central Lab management and Reporting Process
    • Infrastructure and IT Processes

    The anonymised summary of this GAP analysis can be found here.

    The exercise revealed that currently the sponsor expertise is scattered throughout the different departments at the university hospitals, raising questions of global oversight, continuity, standardisation and building on expertise. While some hospitals have already invested extensively in the development of a CTU, others are still in the development phase. Yet, common areas for capacity building could be identified. Therefore, KCE Trials has set up a training programme to support the development of the CTUs in this respect. This programme contains topics such as an efficient management of a trial using web-based tools, project management, health economics, defining a trial budget, patient and public involvement in the trial design, pragmatic trials, etc.
    By bringing together the CTUs of the different university hospitals, KCE aims to stimulate discussion across the different hospitals and to develop a cross-university platform to share expertise in the conduct of large, non-commercial, pragmatic, randomized, multi-centre trials in Belgium.
    For researchers who don’t have a connection to a CTU, please feel free to contact KCE Trials Team and we will put you in contact with a CTU who you could potential collaborate with.
     

    published on 13-12-2016
  • Funding opportunities 2017

    KCE Trials 2017 investigator-led call

    KCE Trials is a programme  of publicly funded pragmatic practice-oriented clinical trials.

    On January 18th, 2017, a second call for studies has opened. This call is for investigator-led trials, meaning that investigators who submit a research proposal outline should have the support of a non-commercial sponsor (clinical trial unit) to perform the proposed clinical trial.

    The KCE Trials 2017 Investigator-led call is now closed for submissions.

    The 2017 investigator-led call focuses on comparative effectiveness trials which show clear value for money and have the potential for return on investment. Comparative effectiveness trials compare the benefits and harms of different treatment options that are already in use in the health care system but which have never been adequately compared directly (i.e. which of 2 treatments work better in a real-life situation). Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions for example psychotherapy, diet, life-style interventions, diagnostic tests, surgery or ways to deliver health care.

    Study proposals will be selected based on the need for evidence in clinical practice and possible efficiency improvement for the Belgian health care system. Trials can lead to increased efficiency of the health care system in addition to benefit for patients in the following ways:

    • If positive, the trial may lead to savings for healthcare payers based on the trial results; while patient benefits remain at least the same.
    • Occasionally, a trial may deliver immediate savings for health care payers, just by running the trial, in addition to possible patient benefit. Examples are trials that investigate a shorter duration of an expensive drug/treatment or trials that compare an expensive to a cheaper treatment option, both of which are currently reimbursed.
    • Based on the trial results, there is a possibility to increase patient benefit/quality of life at a reasonable cost.

    To be able to evaluate this criterion, the applicant must provide a good estimate of the costs for the health-care payer (whether RIZIV-INAMI, patients, etc…) of both interventions and relevant alternatives (immediate short term costs). If possible, an indication or description of the potential impact on cost-effectiveness and costs in the longer term is given (e.g. expensive events avoided).
    An overview of the general selection criteria and specific criteria for the 2017 call can be found below

    Who can submit a study proposal (outline) to the 2017 investigator-led call?

    • KCE Trials considers the involvement of a clinical trial unit (CTU) essential for trial design and conduct. Therefore, investigators should have the written support of a CTU when submitting an outline.
      The sponsor team (Chief investigator and CTU) should have the necessary skills, procedures and experience in conducting non-commercial multicentre trials and have the ability to comply with all sponsor related obligations under the applicable laws, including the law of May 7, 2004. If the sponsor is not located in Belgium, they must demonstrate that they benefit from advantages that are similar to the advantages that apply to non-commercial multicentre trials in Belgium (the law of May 7, 2004).

    How to submit a study proposal (outline)?

    • The call will be open to submissions from 18th January, 2017 until 13h on 21st March, 2017
    • As a first step, candidates are asked to submit a research outline. The outline should contain the above mentioned possible efficiency gains for the health-care payer. Shortlisted candidates will be invited to submit a full research proposal at a later stage.
    • All submissions must be done using the dedicated outline form which can be found here. A guidance document on how to complete the outline is available on the KCE website. The completed outline form and applicable attachments should be sent to Trials”at”kce.fgov.be as a pdf document by 13h on 21st March 2017. No paper submissions will be accepted.

    To be deemed valid and to enter the selection process, a submission should:

    • Be received by email before the deadline of 13h on 21st March 2017
    • Be submitted using the appropriate form and be readable
    • Include details of chief investigator and candidate sponsor
    • Include a signed letter of support by a candidate sponsor who qualifies as non-commercial sponsor under the applicable laws, including the law of May 7, 2004 or equivalent e.g. if the sponsor is not located in Belgium, they must demonstrate that they benefit from advantages that are similar to the advantages that apply to non-commercial multicentre trials in Belgium (the law of May 7, 2004).
    • Include a clearly defined research question in the PICO format (Patients, Intervention, Comparator, Outcome)

    Read here the Top ten tips and tricks for a successful research outline

    What happens next?

    • All research outlines received will be assessed for whether or not they are within the scope of the 2017 call. To be considered in scope for the KCE Trials 2017 programme, a research proposal should answer a comparative effectiveness question comparing interventions that already have a proof of concept and are already (even occasionally) used in Belgium. Development trials and implementation studies will be excluded. The primary aim of the trial should be non-commercial.
    • Research outlines that are within scope will be scored by a panel of clinical experts and health economists and prioritised by the KCE Trials Prioritisation Group.
    • Candidates will be informed about the results of the selection procedure in June 2017 at the latest (no individual feedback will be provided).
    • Shortlisted research outlines that are considered highest priority will be evaluated for their methodological quality and scientific value by the Trials Board (TB). The first Trials Board meeting for the 2017 call is planned early in July.
    • For outlines that are shortlisted and invited to submit a full research proposal (FRP) during the TB meeting in July, the sponsor team will have at least 6 weeks to develop and submit their FRP. FRP Form and guidance notes for the 2017 call will be provided in due course.

    Key documents for the 2017 investigator call

    Additional information

    For more information, please contact Trials”at”kce.fgov.be.

    Please note that KCE shall remain entitled at all times to postpone, suspend and/or withdraw any research call (even during the negotiation of the research agreement) upon its own discretion and that KCE shall under no circumstances be obliged to select any pending Full Research Proposal (FRP) or enter into a research agreement after FRP selection. Candidate sponsors can withdraw their submission at any time before signature of the research agreement.

    Questions and any possible complaints regarding decisions of the TB, PG and KCE Board can be sent to trials”at”kce.fgov.be. Decision are final however and there is no organised administrative appeal procedure for candidate sponsors to appeal the decisions.

    SELECTION CRITERIA KCE TRIALS 2017

    Specific criteria investigator-led call 2017

    Expected return on investment (ROI) Highest score: substantial cost savings are expected. Either substantial savings per patient for small populations as well as savings for large populations that are substantial because of the size of the population fall within this category. Interventions with an equivalent effectiveness that result in relevant cost savings compared with existing alternatives also fall within this category.
    High score: Increased patient benefit comes at acceptable extra expense for society.
    Low score: It is very questionable whether the increased patient benefit comes at an acceptable extra expense for society. Research outlines that contain insufficient information to judge the expected ROI will receive a low score.

    General criteria

    Need for Evidence
    • The importance or burden of the health or care problem to those who would use the evidence generated by the proposed study. In particular, whether the trial would likely lead to improved health and care in Belgium and contribute to change in practice.
    • What the proposed study would add to the existing body of knowledge based on a well-documented search for completed and ongoing research.
    Value for Money 
    • The proposed costs of the research are reasonable and commensurate with the work involved.
    • The costs of the trial are reasonable in relation to the likely benefit of the research to decision-makers, patients and the public. In particular, in addition to the health benefits, the results of the research could lead to net saving for the Belgian healthcare system budget or the introduction of more cost-effective interventions (return on investment).
    • The trial results can have an immediate and important impact on the efficiency (decrease of the costs and/or improvement of the results) of the Belgian healthcare system, preferably without the need for an additional implementation project. (see specific criteria 2017)
    Sponsor
    • The sponsor’s team has the necessary skills, procedures and experience in conducting non-commercial multicentre trials and has the ability to comply with all sponsor related obligations under the applicable laws, including the law of May 7, 2004. The candidate sponsor allows KCE to verify these requirements during a visit. If the sponsor is not located in Belgium, said sponsor must demonstrate that it benefits from advantages that are similar to the advantages that apply to non-commercial multicentre trials in Belgium (the law of May 7, 2004).
    • The investigators in all study sites demonstrate an expertise in the disease and patient population that will be studied. 
    Design
    • The study design would answer the research question proposed.
    • 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. Trials evaluating new interventions in development would be excluded.
    • The trial interventions should reflect Belgian current clinical practice as close as possible.
    • A randomised, multicentre design is highly preferred.
    • The use of centralised randomisation and e-CRFs are recommended.
    • A pragmatic design is to be selected if this would be most informative. Only a limited set of variables, needed for the pre-planned analyses, are to be collected. All variables collected need to be well justified
    Patients 
    • The number of participating sites is sufficiently high and the investigators have access to a sufficient number of eligible patients such that the planned recruitment period is kept as short as possible while fully respecting the scientific rigour of the trial. In addition, measures are in place to maximally reduce the risk of a delay in recruitment including the absence of competing trials that may hamper patient recruitment. The investigators allow KCE to verify these requirements during a study site visit.
    Timelines
    • The risk of recruitment delay is considered low.
    • The relevance of the trial results at the time of publication should be justified.
    Implementation
    • 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.
    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.
    Terms and conditions of the research agreement 

     

     

    published on 13-12-2016
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    published on 26-07-2016
  • KCE Trials programme: funding opportunities 2016

    2016 Call (Commissioned workstream)

    The 2016 commissioned workstream from the KCE Trials programme commissions clinical trials that address specific topics or themes, as identified by the panels and prioritisation group during a selection process.

    Commissioning briefs from the 2016 call (closed for submission) are listed below. 

    ID Topic Commissioning Brief Decision Trials Board
    CB-1601 Dietary intervention for newly diagnosed irritable bowel syndrome Commissioning brief (PDF) Shortlisted and candidate sponsor invited to submit a revised full research proposal
    CB-1602 Biologicals for early untreated rheumatoid arthritis Commissioning brief (PDF) Shortlisted and candidate sponsor invited to submit a revised full research proposal
    CB-1603 Step down approach for inhaled corticosteroids in COPD On hold NA
    CB-1604 Optimal nutritional supplement strategy for patients with deficiencies after bariatric surgery Commissioning brief (PDF) Declined, no further submissions possible in the 2016 commissioned workstream
    CB-1605 Optimal duration of anti-PD1 therapy in patients with advanced melanoma Commissioning brief (PDF) Withdrawn 
    CB-1606 Individualised replacement therapy for haemophilia patients Commissioning brief (PDF) Declined, no further submissions possible in the 2016 commissioned workstream
    CB-1607 Deep brain stimulation versus levodopa pump in Parkinson’s disease Commissioning brief (PDF) Withdrawn 
    CB-1608
     
    Azithromycin in children with chronic respiratory symptoms Commissioning brief (PDF) Declined, no further submissions possible in the 2016 commissioned workstream
    CB-1609
     
    Treatment of nocturia Commissioning brief (PDF) Declined, no further submissions possible in the 2016 commissioned workstream
    CB-1610
     
    Combined online and face-to-face treatment for depression Commissioning brief (PDF) Declined, no further submissions possible in the 2016 commissioned workstream
    CB-1611
     
    Evidence-based laboratory test order sets in first line care Commissioning brief (PDF) Recommended for funding with changes
    CB-1612
     
    Prevention of pressure ulcers using multilayer foam dressings Commissioning brief (PDF) Recommended for funding with changes

     


     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Last updated: March 22 2017

    FAMHP statement on the non-commercial status of trials funded under the KCE Trials programme (2004 law), to be added to submission to FAMHP where applicable

    MRC/DH/MHRA Joint Project - Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products

    This UK report on risk adaptive approaches to the management of clinical trials of investigational medicinal products may provide practical ideas as to how pragmatic approaches can be implemented in studies. It complements existing waivers that exist for non-commercial trials.

    Please note that KCE shall remain entitled at all times to postpone, suspend and/or withdraw any research call (even during the negotiation of the research agreement) upon its own discretion and that KCE shall under no circumstances be obliged to select any pending Full Research Proposal (FRP) or enter into a research agreement after FRP selection. Candidate sponsors can withdraw their submission at any time before signature of the research agreement.

    2016 International workstream

    KCE Trials does not only cover clinical trials that are commissioned by KCE. In addition, KCE Trials intends to provide financial support for the participation of Belgian centres to certain international clinical trials that complement KCE’s mission statement. In such cases, KCE’s role will mainly be to assist the (international) study sponsor with the coordination of the participation of certain Belgian centres through a Belgian coordinating centre (BCC) and to fund well-specified BCC activities that are not covered by other funding.

    In this context, KCE intends to provide selected additional funding for the following studies, which already received funding from ZonMw in the Netherlands.

    ID Topic Info Investigator - Sponsor
    KCE-16013 BeNeDuctus Trial - multi-centre, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants More info on this trial Dr Willem Deboode (Radboud umc Amalia Children’s Hospital)  willem.deboode”at”
    radboudumc.nl
    KCE-16014 T4Life Trial - Levothyroxine for euthyroid women with recurrent miscarriage and positive TPO antibodies: a randomized controlled trial More info on this trial Dr Mariëtte Goddijn (AMC Amsterdam) M.Goddijn”at”amc.uva.nl
    KCE-16015 VINCA Trial - Reducing vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia by one-hour infusions instead of bolus injections

    More info on this trial

    Accruing in Belgium

    Dr Marleen van den Berg (VUmc Amsterdam) mh.vandenberg”at”
    vumc.nl

    Belgium contact: An Michiels an.michiels”at”uzleuven.be Belgian Society for Pediatric Hematology and Oncology (BSPHO)

     

    For each of the three studies, a BCC has been identified by the Sponsor and contract negations have started. On October 12th, 2016, the first contract for Belgian participation to a ZonMw study was signed for the study on reducing vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia. 

    ContactKCE Trials
    Phone : +32 (0)2 287 33 88
    Email : trials@kce.fgov.be
    published on 07-06-2016
  • Who can submit a research topic for KCE’s annual programme?

    The call for topic proposals for the annual KCE programme 2017 was closed on 8 September.

    If you wish to receive news on our future call for topics please register here and choose ‘Call for study subjects’ 

    Example of form

    Proposals for research topics can be made by any private person, organisation, institution or policy maker.

    Once per year, the selection of research topics and the elaboration of KCE’s annual research programme takes place according to a specific procedure. This procedure starts with a call for study proposals in June.

    If you wish to be notified on our call for study proposals, please register here.


     

    published on 01-06-2016
  • 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.

    General 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.

    published on 15-12-2015
  • What is KCE Trials?

    Many questions in healthcare are currently not or not sufficiently studied in clinical trials, despite their high societal importance. The KCE concluded in the summer of 2015 that public funding of such trials would be beneficial (Report 246-2015) under certain conditions. These trials not only contribute to better patient care but also to a more efficient use of public resources. 

    The Minister of Public Health Maggie De Block decided in the autumn of 2015 that KCE should launch and manage a programme of pragmatic practice-oriented clinical trials. The available budget for KCE Trials in 2016 and 2017 is 5 million €, increasing to 10 million € from 2018 onwards. More information in Dutch or in French

    For an efficient international and multilingual cooperation, English was adopted as a working language. For that reason all publications, communications and activities will take place in English.

    Which trials are funded?

    Any type of intervention, in any domain of healthcare, can be the subject of a KCE trial, thus not only medicinal products.

    An absolute condition however is that the result of the trial has an immediate impact on patient care or on the efficient use of the healthcare resources and budget. Both national and international trials are eligible for funding.

    In the beginning, priority will be given to trials which can lead to an efficiency gain for the healthcare system within a rather short period. Typical examples are comparative effectiveness trials, preferably randomised, comparing existing interventions.

    KCE Trials does not fund early phase or development clinical research. For this research we refer to other initiatives and institutes, such as the Fonds Wetenschappelijk Onderzoek and the Fonds de la Recherche Scientifique and Innoviris.

    The sponsor conducts the trial

    KCE will select and fund the trials but will not conduct them. The role of the trial sponsor (the person or organisation who takes responsibility for the initiation and management of the trial) is taken by the hospital and investigator team (or similar) who propose the trial together, who also have developed the protocol. The sponsor has to conduct the trial in accordance with the applicable regulations. The concept of sponsor does not have a commercial connotation here.

    The responsibilities of the sponsor include:

    • Preparation of study protocol;
    • Data management, statistics, design, development of forms and databases;
    • Manage requests to the competent authorities and ethics committees
    • Selection, training and management of the researchers and research centres
    • Quality management and monitoring of trials;
    • Reporting of security incidents (safety findings);
    • Management of drug(s) and samples as applicable;
    • Central laboratory and logistics, as applicable
    • Analysis and reporting;
    • Filing

    Three kinds of research (workstreams)

    KCE Trials funds three different research approaches:

    • Commissioned workstream: a ‘top-down’ approach which focuses on funding trials that will answer clinical questions which have been identified and prioritised for their importance to the patients and the healthcare system
    • Investigator-led workstream: a ‘bottom-up’ approach, which begins with open calls where clinicians can propose clinical questions in any topic area.
    • International workstream: KCE Trials also funds Belgian participation in international trials for selected International trials which ask questions that are also important for the Belgian healthcare system.

    - Overview of the three workstreams

    Slides on KCE Trials 2016

    Glossary

    In the glossary some specific terms are explained

     

    ContactKCE Trials
    Phone : +32 (0)2 287 33 88
    Email : trials@kce.fgov.be
    published on 15-12-2015
  • How to submit a research topic for KCE’s annual programme of 2017?

    The call for topic proposals for the annual KCE programme 2017 was closed on 8 September.

    If you wish to receive news on future call for topics please register here and choose ‘Call for study subjects’ 

    Example of form

    1. Assessment of the eligibility criteria

    In order to be taken into account, the topic must meet the following requirements:

    • Did the KCE receive the form at the latest on 7th September 2016 (midnight)?
    • Was the form clearly and entirely completed? Does it allow priority assignment based on the criteria mentioned below?
    • Does the topic belong to one of KCE’s activity domains:
      - Good Clinical Practice (guidelines),
      - Health Technology Assessment
      - Health Services Research
      Research proposals implying the financing of interventional diagnostic or therapeutic studies (clinical trials) will not be considered for the annual programme, but they may be eligible for the KCE Trials programme.
    • Has this topic already been studied by KCE? Does KCE or another public organisation (e.g. Hoge Gezondheidsraad/Conseil Supérieur , WIV/ISP,…) perform or plan a study on the topic? All published KCE-reports as well as the list of all planned or ongoing projects are available on the KCE-website.

    2. Assessment of the priority criteria

    In September 2016, the KCE will make a priority ranking of the topics based on the following criteria:

    • Policy relevance of the proposed topic in terms of decision aid in health services ;
    • Frequency, severity, and room for improvement of the health problem related to the proposed topic;
    • Feasibility of the proposed study.

    For more details on the priority criteria and the methodology, click here.

    In order to make the assessment process as neutral as possible, all proposals are anonymised.

    3. Selection of topics

    First step

    • The priority ranking will be presented to KCE’s Executive Board in October 2016. The Board will then select a shortlist of topics for the provisional study programme of 2017.
    • In November 2016, the initiators of the proposals will be informed whether their proposal was selected for the shortlist.

    For more details on the methodology of this step, click here

    Second step

    • For each topic on the shortlist, the KCE will perform a limited pre-analysis to assess more precisely the methodological feasibility of the study, the availability of data (if applicable) and an estimation of the workload required for the study.
    • Only those proposals of the shortlist will be retained that are truly feasible, taking into account time, budget constraints and human resources.
    • These topics will be presented to the Executive Board in December 2016. The Board will then establish the work programme for 2017.
    • In January 2017 the initiators will be informed whether their proposal was selected for KCE’s 2017 work programme.

    For more details on the methodology of this step, click here

    4. Who will conduct the study?

    • Either the KCE researchers.
    • Or KCE researchers in collaboration with an external scientific team which was selected on the basis of a public tender. 
    • The initiator of the proposal can possibly be invited as an external expert. He can also apply for a tender, if the KCE decides to launch one. 
    published on 01-06-2016
  • Establishment of the definitive study programme for 2017 (second step)

    The call for topic proposals for the annual KCE programme 2017 was closed on 8 September.

    If you wish to receive news on future call for topics please register here and choose ‘Call for study subjects’ 

    Example of form

    1. thorough evaluation of the shortlisted topics

    After acceptation by the Board of the provisional study programme, the KCE researchers will elaborate an “amended topic proposal form” (tpf) for the about 20 topics that were shortlisted. These “amended tpfs” should further refine the study topics and assess whether they are realistic.
    The following aspects will be further explored in depth: the definition of the problem, its policy relevance, current knowledge of the topic, the research questions and related methodology and essential data. Also the time and resources needed to conduct the study will be assessed.

    2. ranking for the final programme

    Based on the information on the “amended tpfs”, the priority scores awarded to the study topic will be re-evaluated and adjusted downwards or upwards where necessary. Then, the 20 study topics will be reclassified in descending priority.

    This classification is divided into three groups.

    • The first group contains the projects with the highest overall score that are effectively selected for the 2017 study programme.
    • The second group includes a few projects that were awarded a high overall score but seem more difficult to achieve. They will only be performed if new opportunities arise (a.o. in terms of available time or human resources).
    • The third group contains the projects that have been excluded because they are infeasible or not expedient.

    3. establishing The 2017 study programme

    The Executive Board will approve the 2017 study programme in December 2016, based on the above selection. This study programme will be composed of:

    • about 20 new projects which, in terms of priority
    • international projects (within the framework of EUnetHTA and HiT);
    • ad hoc projects such as studies requested by the minister, technical committees or the National Institute for Health and Disability Insurance's Drug Reimbursement Commission during the year, and internal methodological reports essential for the proper functioning of the KCE. 
    published on 01-06-2016
  • Application of the priority criteria (first step)

    The call for topic proposals for the annual KCE programme 2017 was closed on 8 September.

    If you wish to receive news on future call for topics please register here and choose ‘Call for study subjects’ 

    Example of form

    1. Anonymisation of all proposals.

    2. Thorough reading and assessment of each proposal

    At minimum 12 people are involved:

    • the members of the KCE management
    • the KCE senior experts
    • 2 other experts specialized in the domain concerned.

    The five priority criteria: 

    • Policy relevance: To what extent can the study provide support to the decision-making process?
    • Importance of the study – Frequency: Will the topic of the study cover a large number of patients, bouts of illness, care providers and/or care institutions?
    • Importance of the study – Severity: Does the topic deal with a serious health or health care issue (life expectancy, quality of life of the patients, quality, continuity of care; accessibility, fairness of the care, social and ethical aspects) or with economic aspects (affordability for patients and/or the relevant authorities; efficiency or judicious use of the available resources)?
    • Importance of the study – Room for improvement: Will the proposed study be able to alleviate the problem? What obstacles can be expected?
    • Feasibility: Is the proposed study likely to be completed within a period of one year?

    The members of the jury can give five different scores to every item: 1 = unsatisfactorily; 2 = fairly; 3 = satisfactorily; 4 = adequately; 5 = perfectly. 

    The average and the standard deviations of the scores will be calculated.
    Every difference of opinion based on the standard deviation or the comments of the members of the jury will be discussed. The object of these deliberations is to reach a consensus which may involve an adjustment of the scores.

    The overall priority score per research proposal will be calculated by by adding up the five average scores. The greater the end result of the sum, the greater the priority of the proposal.

    3. establishing the Shortlist and the provisional programme

    The best scored research topics will be included in a shortlist of some 20 new study topics. This shortlist will be presented to the KCE Executive Board in October 2016. The Executive Board may adjust the pre-set priorities and will ultimately make the provisional programme for 2017.

    published on 01-06-2016