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The GetReal Initiative

Deliverables

Educational activities (workshops, courses) on indirect comparison, network meta-analysis, ADDIS (M18)

Task 135 Dissemination Training M131 UMCG Astellas AmgenAs part of the effort to promote uptake and understanding of ADDIS and the underlying theory and methodology we aim to develop and give courses and workshops showcasing the tools power D122D123 Workshops are already planned with HTA bodies ZIN and regulatory bodies MEB and we expect to organise at least one such event per year We also expect to run one course per year depending on demand and availability of teaching staffbudget Training materials will be made available via the RWE Navigator Task Force members will also work directly with Think Tank members and the broader GetReal RWE Research Community to promote ADDIS widely Task 151 Education and training UMCU UMCG M1231In order to ensure there is sufficient support for new users of the tools and knowledge generated in The GetReal Initiative it is essential to ensure there is an appropriate education and training programme that can be sustained beyond the term of this project The Eduction and Training platform developed as part of IMI GetReal will also provide a host for these eduction activities with short online courses being developed on the tools Each Task Forceworkgroup leader will be responsible for developing the educational materials required to support new users implement the tools and approaches being promoted by the GetReal Initiative D121 D122D123 It is envisaged that during the course of the project new materials will be incorporated within the existing GetReal course modules however beyond the term of this project additional modules may be developed to incorporate new findings form the Think Tank and task forces The content of the currently available Education Training Programme will be continually updated based on feedback from course participants and training materials from the task forces D124

Develop new public website

Task 3.6 Public website (website live: M4, website maintaining M4-M24) (UMCU, NICE) WP3 will develop, manage and maintain the public website (D3.12). The public website will contain general information about the project for a broader public, whereas the RWE Navigator will function as the platform for the project where all the GetReal outputs can be found. The public website will include items such as general project information, news and newsletters, events and event outputs, tool information and the key results of the project. The website needs to be a functional, user friendly website.

Educational activities (workshops, courses) on indirect comparison, network meta-analysis, ADDIS (M6)

Task 1.3.5 Dissemination & Training (M1-24) (UMCG, Astellas, Amgen) As part of the effort to promote uptake and understanding of ADDIS and the underlying theory and methodology, we aim to develop and give courses and workshops showcasing the tool’s power (D1.22/D1.23). Workshops are already planned with HTA bodies (ZIN) and regulatory bodies (MEB) and we expect to organise at least one such event per year. We also expect to run one course per year, depending on demand, and availability of teaching staff/budget. Training materials will be made available via the RWE Navigator. Task Force members will also work directly with Think Tank members and the broader GetReal RWE Research Community to promote ADDIS widely. Task 1.5.1: Education and training (UMCU, UMCG) (M12-24) In order to ensure there is sufficient support for new users of the tools and knowledge generated in The GetReal Initiative it is essential to ensure there is an appropriate education and training programme that can be sustained beyond the term of this project. The Eduction and Training platform developed as part of IMI GetReal will also provide a host for these eduction activities, with short online courses being developed on the tools. Each Task Force/workgroup leader will be responsible for developing the educational materials required to support new users implement the tools and approaches being promoted by the GetReal Initiative (D1.21, D1.22/D1.23). It is envisaged that during the course of the project, new materials will be incorporated within the existing GetReal course modules, however beyond the term of this project additional modules may be developed to incorporate new findings form the Think Tank and task forces. The content of the currently available Education & Training Programme will be continually updated based on feedback from course participants and training materials from the task forces (D1.24).

Updated GetReal Education & Training Programme

Task 151 Education and training UMCU UMCG M1231In order to ensure there is sufficient support for new users of the tools and knowledge generated in The GetReal Initiative it is essential to ensure there is an appropriate education and training programme that can be sustained beyond the term of this project The Eduction and Training platform developed as part of IMI GetReal will also provide a host for these eduction activities with short online courses being developed on the tools Each Task Forceworkgroup leader will be responsible for developing the educational materials required to support new users implement the tools and approaches being promoted by the GetReal Initiative D121 D122D123 It is envisaged that during the course of the project new materials will be incorporated within the existing GetReal course modules however beyond the term of this project additional modules may be developed to incorporate new findings form the Think Tank and task forces The content of the currently available Education Training Programme will be continually updated based on feedback from course participants and training materials from the task forces D124

General consortium meetings and key governance meetings scheduled (M2)

Deliverable due date: M2, M10 Task 3.2 Organize project meetings (M1-M24) (UMCU, GSK) WP3 will schedule, prepare (draft agendas, arrange logistical details), execute and report (minutes/action lists) general consortium meetings (kick-off/annual meeting) and key governance meetings (D3.5/D3.6). These meetings will be included in the communication and dissemination plan and will be aligned with external communication activities. WP3 will also support organizing the key meetings planned in WP1 and advise on how activities can be optimized to achieve stakeholder communication and engagement objectives (see also T3.3). WP3 will organize additional events as (and if) needed. This could include a closing event modelled on the successful closing event of IMI GetReal in Brussels in November 2016. Such events will involve all members of the GetReal Community, Think Tank and Task Forces as much as possible. WP3 will also look for synergies with other activities.

Communication plan and periodic updates (M12)

Deliverable due dates: M3, 12, 18 Task 3.3 Developing a communication plan (M1-M24) (UMCU, GSK) WP3 will communicate the outputs of the project to all important stakeholders. A communication plan (D3.7/D3.8/D3.9) will be developed to support the overall project goals, create awareness for the project and make sure the outputs reach the right stakeholders. The communication plan will describe, among others, the overall communication goals and activities, planned target groups, the communication strategy, dissemination channels (mix of different tools: website, newsletters, webinars, etc.), and an external communication plan. Ongoing monitoring and evaluating and updating the communication plan on a regular basis will make sure the quality of the overall communication approach will continue to improve throughout the project. Furthermore, WP3 will work closely together with WP1 to disseminate the project’s key outputs to stakeholders and with WP2 to include the business goals, marketing objectives and market research outcomes in the communication plan.

Think Tank Meeting Minutes/white papers (M12)

Task 1.1.3 Implementation of the Think Tank (M6-M24) (GSK, NICE, ZIN, UMCU, SARD, Takeda, Lilly, AZ, UCB, Bayer, Amgen, UMCG, LA-SER). Delivery date M6, 12, 18, 24 The appointed members of the Think Tank will convene periodically (virtual and/or in real-life) to enable scientific exchange, to prioritize RWE barriers and/or opportunities and to discuss results from the Task Forces. The outcomes of the Think Tank can lead to vision documents including priority areas for future research and policy recommendations. In the event that a new Task Force is recommended by the Think Tank, the EPMT will approve the initiation of activities and make the final decision. The Think Tank members will help define the scope of the Task Force, help identify Task Force Leaders, support the identification of Task Forces contributors. WP3 will work with the Task Force Leaders to define the timelines for delivery and allocate budget. The Think Tank will also review outputs from ongoing Task Forces and work with Task Forces (e.g. through consultations) to implement their dissemination and stakeholder engagement plan. Members of the Think Tank will act as global ambassadors for the outputs of the Task Forces. The outcomes of the meetings will be recorded (D1.2/D1.3/D1.4/D1.5). In addition to Task Forces, the Think Tank will also identify topics to be discussed in a broader scientific forum. It is envisaged that two large scientific meetings will be conducted throughout the duration of the current project. The model of these meetings will be based on the successful closing event of IMI GetReal in Brussels in November 2016 and the stakeholder round table in June 2016 in London. Project Management, event management and stakeholder engagement activities conducted by the Think Tank and Task Force Leaders will be supported by WP3.

PragMagic tool assessment using existing trial data

Task 123 Demonstrate the use of the PragMagic tool for EFPIA academia regulatory HTA and patients M2M14 UMCU Bayer Lilly UCB IAPOTo demonstrate the use of the PragMagic tool for pragmatic trial design and evaluation trial data made available by EFPIA partners andor taken from clinical trialsgov will be entered into the tool as part of pilot studies The findings will be documented and used as a discussion base and feedback possibility to further improve the tool D18

Task Force A charter established

Task 1.2.1 Establish the Pragmatic Trial Task Force (M1-M3) (UMCU, Lilly, Bayer, LA-SER, GSK, AZ, UCB, IAPO) The Task Force will be established by the Task Force leaders and will include subject matter experts from industry, academia, regulators, HTAs, physicians and patient representatives. Once established, the task force will develop a charter which documents the agreed ways of working, roles and responsibilities for the different tasks, clearly defined scope for the outputs to be developed and a detailed project plan to facilitate delivery (D1.6).

Statistical approaches for 'enriched' Trials: Best practice recommendations Publication

Task 143 Publication of guidance best practice recommendations M1824 LASER GSK SARDPublications of Best Practice Recommendations 2 publications expected will report the outputs of the different discussions and decisions made The publication process will be initiated and the first submission will be aimed for M24 in highimpact journals D120

Detailed project management plan and periodic updates (M12)

Deliverable due dates: M2, 12, 18 Task 3.1 Project management and coordination (M1-M24) (UMCU, GSK) One of the key activities of WP3 is to run an effective project management, which includes: • The overall coordination and management of the project; • Day-to-day project correspondence (internal and external); • Keeping track of the project schedule and budget and report on project progress along milestones and deliverables deadlines; • Develop, implement and maintain a project infrastructure, including an internal web space where important project documents can be shared among consortium members in a secured way; • Dealing with legal issues and contract management to ensure EC requirements and IMI 2 JU regulations are met; • Support other WPs and cross WP activities where possible and facilitate collaboration between partners and external parties; • Establish and manage the GetReal RWE Research Community. In order to run an effective project management, a detailed project management plan (D3.1/D3.2/D3.3) and progress tracking tools (D3.4) to monitor the work conducted on the project will be developed. The project plan and tracking tools will be updated on a regular basis.

Tracking tools to track all the work conducted on the project

Deliverable due dates: M2, 12, 18 Task 3.1 Project management and coordination (M1-M24) (UMCU, GSK) One of the key activities of WP3 is to run an effective project management, which includes: • The overall coordination and management of the project; • Day-to-day project correspondence (internal and external); • Keeping track of the project schedule and budget and report on project progress along milestones and deliverables deadlines; • Develop, implement and maintain a project infrastructure, including an internal web space where important project documents can be shared among consortium members in a secured way; • Dealing with legal issues and contract management to ensure EC requirements and IMI 2 JU regulations are met; • Support other WPs and cross WP activities where possible and facilitate collaboration between partners and external parties; • Establish and manage the GetReal RWE Research Community. In order to run an effective project management, a detailed project management plan (D3.1/D3.2/D3.3) and progress tracking tools (D3.4) to monitor the work conducted on the project will be developed. The project plan and tracking tools will be updated on a regular basis.

Statistical approaches for analysis of pragmatic trials

Task 127 Statistical Approaches for Pragmatic Trials evaluation of statistical issues M212 UMCU Lilly GSK Bayer LASEREvaluation of statistical issues specific to the design and analyses of pragmatic trials Subsequent identification of existing statistical tools and techniques which may be appropriate to overcome these issues Documentation of results D110

Documentation of PragMagic pilot

Task 124 Determine requirements for PragMagic uptake by academic and industry scientists M2M14 UMCU Lilly GSK Bayer SARD EFPIA and academic partners from within the GetReal Initiative will be asked to select a more pragmatic clinical trial currently being plannedevaluated within their organisation and utilise PragMagic in the designevaluation discussions Feedback will be gathered and documented D19

Communication plan and periodic updates (M24)

Deliverable due dates M3 12 24Task 33 Developing a communication plan M1M31 UMCU GSKWP3 will communicate the outputs of the project to all important stakeholders A communication plan D37D38D39 will be developed to support the overall project goals create awareness for the project and make sure the outputs reach the right stakeholders The communication plan will describe among others the overall communication goals and activities planned target groups the communication strategy dissemination channels mix of different tools website newsletters webinars etc and an external communication plan Ongoing monitoring and evaluating and updating the communication plan on a regular basis will make sure the quality of the overall communication approach will continue to improve throughout the project Furthermore WP3 will work closely together with WP1 to disseminate the projects key outputs to stakeholders and with WP2 to include the business goals marketing objectives and market research outcomes in the communication plan

Social media strategy and execution

Task 3.4 Develop social media strategy and execution (M1-M24) (UMCU, VT) WP3 will develop and execute a social media strategy (focus on Twitter and LinkedIn) (D3.10), aiming to promote the project image, inform stakeholders and the general public and to share key results of the project. It will also reinforce the communication activities as described in the communication. The social media strategy will include measureable objectives, a content plan and makes use of the market research outcomes and align with the marketing objectives and business strategy set out by WP2. The social media strategy will be included in the communication plan and social media activities will be aligned with information on the project’s public website.

Data Management Plan (M18)

Deliverable due dates M6 18 31Task 38 Development and updating of data management plan M1M24 UMCU GSKWP3 will devise a data management plan including detailed information on the procedures that will be implemented for data collection storage protection retention reuse andor destruction Compliance confirmation with current national and EU legislation will be included See also section 5 EthicsWP3 will also include in the plan a policy to avoid mission creep risks making sure that the collected data is harvested on a strict need to know and need to use basis As such a privacy impact assessment will also be included in the planThe position of Data Protection Officer will be established within all participating organisations and their opinionconfirmation that all data collection and processing will be carried out according to current EU and national legislation included in the project documentation D313D314D315 The first version of the Data Management Plan will be delivered in month 6 but the Data Management Plan evolves and gains more precision and substance during the lifespan of the project with additional reporting periods in M18 and M31

Communication plan and periodic updates (M3)

Deliverable due dates: M3, 12, 18 Task 3.3 Developing a communication plan (M1-M24) (UMCU, GSK) WP3 will communicate the outputs of the project to all important stakeholders. A communication plan (D3.7/D3.8/D3.9) will be developed to support the overall project goals, create awareness for the project and make sure the outputs reach the right stakeholders. The communication plan will describe, among others, the overall communication goals and activities, planned target groups, the communication strategy, dissemination channels (mix of different tools: website, newsletters, webinars, etc.), and an external communication plan. Ongoing monitoring and evaluating and updating the communication plan on a regular basis will make sure the quality of the overall communication approach will continue to improve throughout the project. Furthermore, WP3 will work closely together with WP1 to disseminate the project’s key outputs to stakeholders and with WP2 to include the business goals, marketing objectives and market research outcomes in the communication plan.

Statistical Approaches for 'enriched' Trials Task Force Charter

Task 1.4.1 Establish Task Force & Scope (M1-M5) (LA-SER, GSK, SARD) The Task Force will include subject matter experts from industry, academia, regulators, HTAs, physicians and patients. The Task Force will be established by the Task Force Leaders based on the scope and structure as defined above. Potential experts will be identified from workshops conducted as part of the original GetReal project and contacted to explain the project, the expected outputs and invite them to participate in the Task Force. Once established, the group will develop a charter (D1.19) which documents the agreed ways of working, roles and responsibilities, clearly defined scope for the Guidelines/Best Practice Recommendations to be developed and a detailed project plan to facilitate delivery. This will include agreement on the tools and techniques to be assessed, definition of the questions to be addressed, a priori definition of confidence grades (grade A, B, C) for the guidance items and deliverables.

Pilot report use of ADDIS in industry

Task 132 Determine requirements for ADDIS uptake within HTA agencies regulatory bodies and industry M1M12 UMCG Astellas Amgen ZINPilot projects will be performed with key partners to determine the requirements for ADDIS to become part of the process of analysing the relative effectiveness of drugs and of communicating these analyses and their results Testing will take place both with regulators such as MEB HTA parties such as ZIN and industry partners such as Astellas and a discussion is running with Novo Nordisk pharmaceutical companies and Pharmerit an international research service provider D115 Examples of requirements could be a private installation process within an organisation for sensitive data or a specific import or export format to better connect to the databases of a company or institution We will also attempt to set up a collaboration with the MAGIC organisation to allow ADDIS network metaanalyses to be used in their tool

Detailed project management plan and periodic updates (M24)

Deliverable due dates M2 12 24Task 31 Project management and coordination M1M31 UMCU GSKOne of the key activities of WP3 is to run an effective project management which includesThe overall coordination and management of the projectDaytoday project correspondence internal and externalKeeping track of the project schedule and budget and report on project progress along milestones and deliverables deadlinesDevelop implement and maintain a project infrastructure including an internal web space where important project documents can be shared among consortium members in a secured wayDealing with legal issues and contract management to ensure EC requirements and IMI 2 JU regulations are metSupport other WPs and cross WP activities where possible and facilitate collaboration between partners and external partiesEstablish and manage the GetReal RWE Research CommunityIn order to run an effective project management a detailed project management plan D31D32D33 and progress tracking tools D34 to monitor the work conducted on the project will be developed The project plan and tracking tools will be updated on a regular basis

Summary of other existing non-for profit organisational models

Task 2.2 Review of other existing world leading professional organisations (VT, Takeda, GSK) (M1-M9) To further inform the business plan, a number of initiatives/organisations with similar ambition and public private collaborative model to GetReal e.g. CTTI, E-source forum as well as IMI projects such as EHR4CR and OpenPHACTs will be identified and reviewed to better understand arrangements for income, organisation and governance. The output of the review will include a description of each membership model: target sectors for membership: member benefits and costs (eg subscriptions); membership tiers or levels; and an outline marketing approach to secure and retain members, governance structures and associated roles and responsibilities. From this review, options for different membership models will be generated, given the remit of the organisation and the range of products and services likely to be offered. A second output from this review will be recommendations on possible governance arrangements, and expertise required (D2.2).

White paper on current barriers to the acceptability of pragmatic trial data in decision making

Task 1.2.2 Identification of barriers to the use of PCT data in decision making and prioritisation of efforts (M2-M8) (UMCU, Lilly, Bayer, LA-SER, GSK, AZ, UCB) The acceptability of pragmatic trial data in decision making will be assessed, critical barriers will be identified and an action plan will be defined to address those barriers identified as priority. It is envisaged that the Task Force will identify a number of pragmatic trials that have concluded recently and have been discussed directly with regulators and payers. In collaboration with the Think tank insights will also be gained through direct interaction with EUnetHTA, HTAs and regulatory bodies, using PragMagic as a tool to facilitate discussion and understanding about these barriers and possibilities to overcome them. The outcomes of the assessment and the possible guidance received by decision-makers will be captured in a white paper (D1.7) and fed into the development of the PragMagic Tool (Tasks 1.2.3-1.2.6) and the statistical approaches (Tasks 1.2.7-1.2.8).

Training materials for PragMagic

Task 151 Education and training UMCU UMCG M1231In order to ensure there is sufficient support for new users of the tools and knowledge generated in The GetReal Initiative it is essential to ensure there is an appropriate education and training programme that can be sustained beyond the term of this project The Eduction and Training platform developed as part of IMI GetReal will also provide a host for these eduction activities with short online courses being developed on the tools Each Task Forceworkgroup leader will be responsible for developing the educational materials required to support new users implement the tools and approaches being promoted by the GetReal Initiative D121 D122D123 It is envisaged that during the course of the project new materials will be incorporated within the existing GetReal course modules however beyond the term of this project additional modules may be developed to incorporate new findings form the Think Tank and task forces The content of the currently available Education Training Programme will be continually updated based on feedback from course participants and training materials from the task forces D124

Detailed project management plan and periodic updates (M2)

Deliverable due dates: M2, 12, 18 Task 3.1 Project management and coordination (M1-M24) (UMCU, GSK) One of the key activities of WP3 is to run an effective project management, which includes: • The overall coordination and management of the project; • Day-to-day project correspondence (internal and external); • Keeping track of the project schedule and budget and report on project progress along milestones and deliverables deadlines; • Develop, implement and maintain a project infrastructure, including an internal web space where important project documents can be shared among consortium members in a secured way; • Dealing with legal issues and contract management to ensure EC requirements and IMI 2 JU regulations are met; • Support other WPs and cross WP activities where possible and facilitate collaboration between partners and external parties; • Establish and manage the GetReal RWE Research Community. In order to run an effective project management, a detailed project management plan (D3.1/D3.2/D3.3) and progress tracking tools (D3.4) to monitor the work conducted on the project will be developed. The project plan and tracking tools will be updated on a regular basis.

Think Tank Meeting Minutes/white papers (M6)

Task 1.1.3 Implementation of the Think Tank (M6-M24) (GSK, NICE, ZIN, UMCU, SARD, Takeda, Lilly, AZ, UCB, Bayer, Amgen, UMCG, LA-SER). Delivery date M6, 12, 18, 24 The appointed members of the Think Tank will convene periodically (virtual and/or in real-life) to enable scientific exchange, to prioritize RWE barriers and/or opportunities and to discuss results from the Task Forces. The outcomes of the Think Tank can lead to vision documents including priority areas for future research and policy recommendations. In the event that a new Task Force is recommended by the Think Tank, the EPMT will approve the initiation of activities and make the final decision. The Think Tank members will help define the scope of the Task Force, help identify Task Force Leaders, support the identification of Task Forces contributors. WP3 will work with the Task Force Leaders to define the timelines for delivery and allocate budget. The Think Tank will also review outputs from ongoing Task Forces and work with Task Forces (e.g. through consultations) to implement their dissemination and stakeholder engagement plan. Members of the Think Tank will act as global ambassadors for the outputs of the Task Forces. The outcomes of the meetings will be recorded (D1.2/D1.3/D1.4/D1.5). In addition to Task Forces, the Think Tank will also identify topics to be discussed in a broader scientific forum. It is envisaged that two large scientific meetings will be conducted throughout the duration of the current project. The model of these meetings will be based on the successful closing event of IMI GetReal in Brussels in November 2016 and the stakeholder round table in June 2016 in London. Project Management, event management and stakeholder engagement activities conducted by the Think Tank and Task Force Leaders will be supported by WP3.

Think Tank Meeting Minutes/white papers (M31)

Task 113 Implementation of the Think Tank M6M31 GSK NICE ZIN UMCU SARD Takeda Lilly AZ UCB Bayer Amgen UMCG LASERThe appointed members of the Think Tank will convene periodically virtual andor in reallife to enable scientific exchange to prioritize RWE barriers andor opportunities and to discuss results from the Task Forces The outcomes of the Think Tank can lead to vision documents including priority areas for future research and policy recommendations In the event that a new Task Force is recommended by the Think Tank the EPMT will approve the initiation of activities and make the final decision The Think Tank members will help define the scope of the Task Force help identify Task Force Leaders support the identification of Task Forces contributors WP3 will work with the Task Force Leaders to define the timelines for delivery and allocate budget The Think Tank will also review outputs from ongoing Task Forces and work with Task Forces eg through consultations to implement their dissemination and stakeholder engagement plan Members of the Think Tank will act as global ambassadors for the outputs of the Task Forces The outcomes of the meetings will be recorded D12D13D14D15In addition to Task Forces the Think Tank will also identify topics to be discussed in a broader scientific forum It is envisaged that two large scientific meetings will be conducted throughout the duration of the current project The model of these meetings will be based on the successful closing event of IMI GetReal in Brussels in November 2016 and the stakeholder round table in June 2016 in London Project Management event management and stakeholder engagement activities conducted by the Think Tank and Task Force Leaders will be supported by WP3

Data Management Plan (M6)

"Deliverable due dates: M6, 12, 24 Task 3.8 Development and updating of data management plan (M1-M24) (UMCU, GSK)WP3 will devise a data management plan including detailed information on the procedures that will be implemented for data collection, storage, protection, retention, reuse and/or destruction. Compliance confirmation with current national and EU legislation will be included. See also section 5, Ethics. WP3 will also include in the plan a policy to avoid ""mission creep"" risks, making sure that the collected data is harvested on a strict ""need to know"" and ""need to use"" basis. As such, a privacy impact assessment will also be included in the plan. The position of Data Protection Officer will be established within all participating organisations and their opinion/confirmation that all data collection and processing will be carried out according to current EU and national legislation included in the project documentation (D3.13/D3.14/D3.15). The first version of the Data Management Plan will be delivered in month 6, but the Data Management Plan evolves and gains more precision and substance during the lifespan of the project with additional reporting periods in M12 and M24."

Branding project and development house style, including an updated logo and templates

Task 3.5 Branding (M1-M2) (UMCU, VT, GSK) WP3 will develop a distinct project image, building further on the image legacy of GetReal, to increase the visibility of the project and make sure the project is represented in a consistent way. The distinct project image will include a project narrative with clear goals and a mission statement to communicate to all stakeholders and an updated GetReal house style, including an update of the logo and templates for presentations, posters and document (D3.11).

The Think Tank/Task Forces and Research Community Structure and Function

Task 1.1.1 The Think Tank/Task Forces and Research Community Structure and Function (M1-M3) (GSK, NICE, ZIN, UMCU, SARD, Takeda, Lilly, AZ, UCB, Bayer, Amgen, UMCG, LA-SER) A detailed structure of The Think Tank/Task Forces and Research Community Structure and Function will be developed, which will articulate the purpose and mandate of the Think Tank/Task Forces and Research Community and provide clear guidance for potential members regarding their membership (D1.1). The following information should minimally be presented in the structure: how to become a member of the Think Tank/Task Forces/Research Community, who can become a member, what are the responsibilities of the Think Tank/Task Force/Community members, what do members get out of their membership, how often are meetings and broad stakeholder events organized. Task 1.1.2 Establishment of the Think Tank (M1-6) (GSK, NICE, ZIN, UMCU, SARD, Takeda, Lilly, AZ, UCB, Bayer, Amgen, UMCG, LA-SER) International initiatives and organisations will be assessed for the potential for collaboration with The GetReal Initiative, and more specifically their possible membership of the GetReal Think Tank and Task Forces. Membership will not be limited to European organisations as RWE barriers and opportunities span regional boundaries. Potentially relevant RWE initiatives include efforts by ISPOR/ISPE, the Institute for Clinical and Economic Review (ICER), the US National Academy of Medicine, EUnetHTA (e.g. WP5B on additional data collection), CTTI and the Duke-Margolis Center for Health Policy. Senior thought leaders and high level leaders from these international organisations and initiatives will be identified and invited to become members of the Think Tank (M1.1). The Think Tank will be co-chaired by UMCU, NICE and GSK until it transitions to the newly appointed Executive Director in Year 2 of the project. The Executive Director will be accountable for continuing the leadership of the Think Tank beyond the term of the project as outlined in WP2. The RWE Navigator will be utilized to promote the GetReal RWE Research Community and encourage membership from the broader research community – this will be managed through WP3.

Think Tank Meeting Minutes/white papers (M18)

Task 113 Implementation of the Think Tank M6M24 GSK NICE ZIN UMCU SARD Takeda Lilly AZ UCB Bayer Amgen UMCG LASER Delivery date M6 12 18 24The appointed members of the Think Tank will convene periodically virtual andor in reallife to enable scientific exchange to prioritize RWE barriers andor opportunities and to discuss results from the Task Forces The outcomes of the Think Tank can lead to vision documents including priority areas for future research and policy recommendations In the event that a new Task Force is recommended by the Think Tank the EPMT will approve the initiation of activities and make the final decision The Think Tank members will help define the scope of the Task Force help identify Task Force Leaders support the identification of Task Forces contributors WP3 will work with the Task Force Leaders to define the timelines for delivery and allocate budget The Think Tank will also review outputs from ongoing Task Forces and work with Task Forces eg through consultations to implement their dissemination and stakeholder engagement plan Members of the Think Tank will act as global ambassadors for the outputs of the Task Forces The outcomes of the meetings will be recorded D12D13D14D15In addition to Task Forces the Think Tank will also identify topics to be discussed in a broader scientific forum It is envisaged that two large scientific meetings will be conducted throughout the duration of the current project The model of these meetings will be based on the successful closing event of IMI GetReal in Brussels in November 2016 and the stakeholder round table in June 2016 in London Project Management event management and stakeholder engagement activities conducted by the Think Tank and Task Force Leaders will be supported by WP3

Best Practice recommendations for statistical approaches in pragmatic trials

Task 128 Statistical Approaches for Pragmatic Trials Development and publications of the Best Practice Recommendations M1224 UMCU Lilly GSK Bayer LASERFor each of the predefined statistical questions see task 127 guidance and best practice recommendations will be developed D111 Publications of Best Practice Recommendations 2 publications expected will report the outputs of the different discussions and decisions made The publication process will be initiated and the first submission will be aimed for M24 in highimpact journals D120

Data Management Plan (M31)

Deliverable due dates M6 18 31Task 38 Development and updating of data management plan M1M31 UMCU GSKWP3 will devise a data management plan including detailed information on the procedures that will be implemented for data collection storage protection retention reuse andor destruction Compliance confirmation with current national and EU legislation will be included See also section 5 EthicsWP3 will also include in the plan a policy to avoid mission creep risks making sure that the collected data is harvested on a strict need to know and need to use basis As such a privacy impact assessment will also be included in the planThe position of Data Protection Officer will be established within all participating organisations and their opinionconfirmation that all data collection and processing will be carried out according to current EU and national legislation included in the project documentation D313D314D315 The first version of the Data Management Plan will be delivered in month 6 but the Data Management Plan evolves and gains more precision and substance during the lifespan of the project with additional reporting periods in M18 and M31

Task Force B charter established

Task 1.3.1 Establish Task Force: Network meta-analysis and benefit-risk assessment (M1) (UMCG, Astellas, Amgen, ZIN) The Task Force will be established by the Task Force Leaders based on the scope and structure as defined above. The Task Force will consist of the ADDIS team and key partners from HTA agencies, regulatory bodies and industry. The Task Force will focus on increasing the acceptability and use of network meta-analysis and benefit-risk analysis by HTA agencies, regulatory bodies, industry and academia. Additionally the Task Force will help guide the development and testing towards optimal usability and sustainability of ADDIS as a platform for analysis and results communication at key decision points along the medicine lifecyle. Opportunities to include RWE at these decision points will also be discussed by the Task Force. Potential experts will be identified from workshops conducted as part of the original GetReal project and contacted to explain the project, the expected outputs and invite them to participate in the Task Force. Once established, each working group will develop a charter which documents the agreed ways of working, roles and responsibilities, clearly defined scope for the Guidelines/Best Practice Recommendations to be developed and a detailed project plan to facilitate delivery (D1.11)

General consortium meetings and key governance meetings scheduled (M10)

Deliverable due date: M2, M10 Task 3.2 Organize project meetings (M1-M24) (UMCU, GSK) WP3 will schedule, prepare (draft agendas, arrange logistical details), execute and report (minutes/action lists) general consortium meetings (kick-off/annual meeting) and key governance meetings (D3.5/D3.6). These meetings will be included in the communication and dissemination plan and will be aligned with external communication activities. WP3 will also support organizing the key meetings planned in WP1 and advise on how activities can be optimized to achieve stakeholder communication and engagement objectives (see also T3.3). WP3 will organize additional events as (and if) needed. This could include a closing event modelled on the successful closing event of IMI GetReal in Brussels in November 2016. Such events will involve all members of the GetReal Community, Think Tank and Task Forces as much as possible. WP3 will also look for synergies with other activities.

PragMagic 2.0 available online

Task 125 Refinement and upgrading of PragMagic M8M24 UMCU Lilly GSK BayerCritical adaptations and additions needed to PragMagic to increase its value and acceptability both content and software wise as defined by task 121124 and with that its sustainability potential including the development of a plan that guarantees that the information within the PragMagic tool remains uptodate D112 Training materials to support the use of PragMagic will be developed under Task 4 D120

Hiring of an Executive Director

Task 24 Staffing and Organisation VT Takeda GSK UMCU M13M27Staffing activities including recruitment will begin following the approval of the business plan by the GetReal EPMT D24 The first person in post will be the Executive Director who will work remotely D25 A selection committee will be appointed from the Think Tank Task Forces and the GetReal Initiative Partners Once in place the Executive Director in partnership with the support of the GetReal Initiative members will identify and appoint interim Board members The Executive Director and the interim Board members will be accountable for appraising the business plan and making appropriate modifications based on the outputs of WP1 They will finalise the organisational structure covering all roles required including business development website management financeITHR support fund raising These final business plans D26 will be reviewed and approved by the GetReal General Assembly M27 For the last 36 months of the IMIfunded project the Executive Director and interim board members will gradually transition tasks from WP1 and WP3 It is also envisioned that the new Board will actively work to expand ongoing activities introduce tiered membership fees and arrange a GetReal Conference to increase revenue potential prior to the end of the project termTogether the newly appointed team will be accountable for finalising the staffing and initiating marketing activities from M20 to ensure there is sufficient governance in place and revenue available to sustain all activities from M32 onwards

Updated version ADDIS online

Based on the outcomes of piloting and the sustainability plan the final version of the ADDIS software tool will be created

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Publications

The GetReal Trial Tool: design, assess and discuss clinical drug trials in light of Real World Evidence generation

Author(s): Zuidgeest MGP, Goetz I, Meinecke AK, Boateng D, Irving EA, van Thiel GJM, Welsing PMJ, Oude-Rengerink K, Grobbee DE
Published in: J Clin Epidemiol, 2021, ISSN 0895-4356
Publisher: Elsevier BV
DOI: 10.1016/j.jclinepi.2021.12.019