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    The description :skip to main content show menu close home more about mapps participants adaptsmart legacy stakeholder collaboration medicines adaptive pathways to patients (mapps) seek to foster access to beneficial...

    This report updates in 30-Jun-2018

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skip to main content show menu close home more about mapps participants adaptsmart legacy stakeholder collaboration medicines adaptive pathways to patients (mapps) seek to foster access to beneficial treatments for the right patient groups with high unmet medical needs at the earliest appropriate time in the product life-span in a sustainable fashion . a key component of mapps is stakeholder collaboration . right patient groups beneficial treatments high unmet medical need earliest appropriate time sustainable fashion adaptsmart beneficial treatments mapps is not a rush to expose patients to untested treatments. clinical data must show that the benefits will very likely outweigh the risks in the defined patient group. key questions addressed by adapt smart: how can sufficient evidence be gathered in a mapps pathway to demonstrate a positive benefit-risk balance? how can real world data (rwd) be used to bridge the efficacy to effectiveness gap? what are patient's and health care providers’ (hcps) views on mapps? how is the collection of evidence for quality, safety and efficacy evaluations governed within a mapps approach? how can sufficient evidence be gathered in a mapps pathway to demonstrate a positive benefit-risk balance? lessons from adapt smart a prerequisite of mapps is stakeholder agreement on a prospective plan about evidence generation throughout the medines life cycle. a core principle of the mapps pathway is the use of real world data (rwd) to supplement randomized clinical trial data. robust tools to appropriately collect, analyse and interpret rwd, the use of (conditional) marketing authorisation based on single-arm studies and improved methods to integrate network meta-analysis in regulatory decision-making will be a key facilitator of the mapps approach. download links adapt smart report: gathering evidence through real-life use to supplement clinical trial data - executive summary only (pending publication) adapt smart report: indirect comparisons (network meta-analysis) and single arm studies - executive summary only (document under review) how can real world data (rwd) be used to bridge the efficacy to effectiveness gap? lessons from adapt smart the use of rwd (e.g. registries, electronic health records etc.) to supplement data from randomised clinical trials can speed up the decision-making process. integrating evidence from different sources is key to satisfying different stakeholder needs which need to be considered over the entire life cycle of a product. the infrastructure to study disease epidemiology and relative effectiveness of medicines needs to be further developed. download links adapt smart workshop report: select methods, toolset and datasets to perform scenario studies what are patient's and health care providers’ (hcps) views on mapps? lessons from adapt smart patients pointed out the need for a close consideration of the trade-off between benefits and risks in mapps. a preliminary study showed that hcps are willing to provide patients with the appropriate information, reasons and advantages of joining a disease registry, when considering a mapps product. hcps expressed an unanimous willingness to be part of the iterative decision-making process when developing, licensing and considering the financial coverage of a mapps product. download links adapt smart report: inventory and analysis of increased uncertainties of health care providers, patients and other stakeholders - executive summary only (document under review) adapt smart workshop report: patient uncertainties and exploring the ethical and legal considerations of mapps how is the collection of evidence for quality, safety and efficacy evaluations governed within a mapps approach? lessons from adapt smart the requirement to demonstrate a positive benefit-risk balance through a mapps approach will not be different from medicinal products that obtain a market authorisation via a standard procedure. no legal hurdles have been identified in a mapps approach with respect to the framework governing the approval of medicinal products and market access rules. to what extent some uncertainties may remain with regard to non-legislative provisions need to be further assessed. download links adapt smart report: legal constraints with regard to mapps adapt smart report: impact of adaptive licencing and adaptive access on ip and regulatory exclusivity right periods close right patient groups under mapps, a product is initially “fast-tracked” exclusively for patients who will benefit the most. it is therefore important that in the beginning only those patients will get the new medicine. key questions addressed by adapt smart: how can iterative developments in mapps support the managed introduction of new treatments for the right patient groups? what are the main uncertainties for patients and how can they be mitigated? how can we ensure that medicinal products approved under mapps are appropriately used? could restricting prescribing of medicinal products to a defined patient group raise new ethical or legal considerations? how can iterative developments in mapps support the managed introduction of new treatments for the right patient groups? lessons from adapt smart in the mapps context, an iterative development means approval in stages, starting with a restricted patient population and then expanding to wider patient groups. iterative development will rely on well-informed decisions about what the target patient population that receives initial approval should be and which patient populations are subject of possible additional indications. new scientific developments related to the growing stratification of treatment-eligible populations and methods to support decisions based on smaller samples are currently under development. download links adapt smart report: approval in stages - iterative development in mapps - executive summary only (pending publication) what are the main uncertainties for patients and how can they be mitigated? lessons from adapt smart patient perspectives are full of questions but one certainty: there is no compromise on safety. mitigation of patient uncertainties requires continuous engagement of all stakeholders. there is a key role of patient organisations and patient advocates as information providers. download links adapt smart report: inventory and analysis of increased uncertainties of health care providers, patients and other stakeholders - executive summary only (document under review) adapt smart workshop report: patient uncertainties and exploring the ethical and legal considerations of mapps how can we ensure that medicinal products approved under mapps are appropriately used? lessons from adapt smart a variety of different tools and systems are in place in eu member states to guide the appropriate use of medicinal products, including treatment guidelines, diagnostic tools, restrictions by prescriber speciality and registries. different enforcement mechanisms exist in eu member states for managing non-compliance to tools/systems that guide appropriate use. more alignment is needed between eu member states with regard to the implementation of tools and systems for guiding appropriate use in the mapps context. download links adapt smart report: an overview of tools and systems to guide appropriate use of medicinal products in twelve eu member states adapt smart workshop report: tools and systems used for prescription control & the ethical and legal aspects of adaptive decision making could restricting prescribing of medicinal products to a defined patient group raise new ethical or legal considerations? lessons from adapt smart any prescribing tools imposed should not impact on healthcare professionals’ freedom to prescribe under the duty of care for the patient. the use of disease registries to support data collection is preferable, but not available or practical in all eu member states, as well as practical options to meet the dat

URL analysis for adaptsmart.eu


https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d3.09.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20workshop%20d2.05-d3.02_1.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d1.02.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d2.07_0.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d3.04.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d3.02.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20blog%20d2.03.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20workshop%20d3.06.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d2.05.pdf
https://www.infographic.adaptsmart.eu/partners
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d2.04.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d2.04_0.pdf
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20d2.03.pdf
https://www.infographic.adaptsmart.eu/node/3
https://www.infographic.adaptsmart.eu/sites/adaptsmart/files/as%20deliverable%20hg.01_0.pdf

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