HORIZON EUROPE
Europeo
Specific Challenge:Numerous efforts have been undertaken to standardise the way HRQOL and PRO data are conducted and reported in cancer clinical trials. These include recommendations to standardise reporting and drafting of clinical trials, translations in clinical trials, and how to develop and standardise measures for use in clinical trials. However, there are no agreed standards on how to analyse HRQOL and PRO data in clinical trials and subsequently, interpret the findings. The various ways data are analysed and interpreted make it difficult to compare results across trials, and hinder the application of research findings to inform physicians, patients, caregivers, policy makers, reimbursement authorities and other stakeholders. Lack of standardisation can lead to variation in the analysis of results and could result in two near-identical trials being analysed in different ways, leading to potential differences in data interpretation.
A number of systematic reviews from randomised controlled trials (RCTs) have highlighted the current lack of standardisation in this field and reported the following key findings:
a lack of clear HRQOL and PRO research o...
ver más
Specific Challenge:Numerous efforts have been undertaken to standardise the way HRQOL and PRO data are conducted and reported in cancer clinical trials. These include recommendations to standardise reporting and drafting of clinical trials, translations in clinical trials, and how to develop and standardise measures for use in clinical trials. However, there are no agreed standards on how to analyse HRQOL and PRO data in clinical trials and subsequently, interpret the findings. The various ways data are analysed and interpreted make it difficult to compare results across trials, and hinder the application of research findings to inform physicians, patients, caregivers, policy makers, reimbursement authorities and other stakeholders. Lack of standardisation can lead to variation in the analysis of results and could result in two near-identical trials being analysed in different ways, leading to potential differences in data interpretation.
A number of systematic reviews from randomised controlled trials (RCTs) have highlighted the current lack of standardisation in this field and reported the following key findings:
a lack of clear HRQOL and PRO research objectives;a lack of standardisation of basic statistical terms such as compliance and completion rates;the use of suboptimal statistical practices and a variety of statistical methods not well justified with respect to analysing HRQOL and PRO data;the use of a variety of approaches to handling missing data. There is an urgent need to develop clear standards and guidelines, endorsed by a broad range of stakeholders, to improve how HRQOL and PRO data are analysed in cancer clinical trials. This would also help promote HRQOL and PROs as potential primary or co-primary endpoints (when relevant) in cancer clinical trials. Such standards will support the full use and understanding of HRQOL and PROs in drug development and drug and device approval by regulators and health technology assessment (HTA) bodies, but importantly it will also support better communication of PRO results to clinicians and patients with the potential to inform and improve shared decision-making.
Scope:The scope of this Call topic is to develop recommendations for the different analyses and interpretations of HRQOL and PRO endpoints in cancer clinical trials that will be tailored towards addressing specific research objectives within each clinical trial. This Call topic aims for a global scope and is of strong interest to individuals from various regulatory and HTA bodies, key cancer organisations, the pharmaceutical industry, specialised vendor organisations, academic societies and international patient organisations. The buy-in of these various key stakeholders is crucial, as this will help identify a set of similar expectations, facilitate the implementation of these recommendations, and harmonise the analysis and interpretation of HRQOL and PRO data on a global scale.
The main objectives are to:
achieve international consensus, across stakeholders, on the optimal use of HRQOL and PRO data in cancer clinical trials;improve the quality of statistical analysis of HRQOL and PRO data in cancer clinical trials;improve the standards of reporting of HRQOL and PRO data, and as such the interpretability of the data. It is hoped that this will result in more reliable interpretation, and ultimately faster dissemination, of HRQOL and PRO findings, as well as cross-referencing within and between different cancer settings, whenever this is deemed feasible.
Expected Impact:A consensus and clear set of agreed methodological recommendations for the statistical analysis of HRQOL and PRO data in cancer studies will improve their interpretability. This is an important prerequisite for better adoption and increased use of these outcomes in various decision-making contexts (regulatory approval, HTA/reimbursement decisions, shared decision making between physicians and patients). Importantly, the expected outcomes of this initiative will be of mutual benefit to all stakeholders involved, including the most important beneficiary of healthcare, the patient. Reaching a broad international consensus is a prerequisite for a broader adoption of HRQOL and PRO data and is likely to result in:
more reliable findings and faster dissemination of HRQOL and PRO data in cancer studies; advances in statistical science and improved statistical practice in cancer studies;improved interpretability of the data because of greater familiarity with standardised reporting; broader use and adoption of PRO data to inform benefit-risk evaluation in regulatory appraisals, added benefit evaluation in HTAs and reimbursement decision processes as well as shared treatment decision making contexts;better and improved shared decision making between patients and their treating physicians which may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success and a reduction in health‐care cost;better and more efficient use of increasingly finite research and healthcare funding;improved and more efficient clinical trial designs that also investigate the cancer patient perspective on treatment outcomes. Applicants should indicate how their proposal will impact the competitiveness and industrial leadership of Europe by, for example engaging suitable small and medium-sized enterprises (SMEs).
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Características del consorcio
:
La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signat... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Standard evaluation form
Proposal templates are available after entering the submission tool
Proposal template stage 1
Proposal template stage 2
IMI2 Model Grant Agreement
Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
1st Amended IMI2 Amended Annual Work Plan 2019
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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