EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES
With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized...
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| Veröffentlicht in: | International journal of technology assessment in health care 2015-01, Vol.31 (4), p.207-209 |
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| container_title | International journal of technology assessment in health care |
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| creator | Levin, Leslie |
| description | With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach. |
| doi_str_mv | 10.1017/S0266462315000422 |
| format | Article |
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| fulltext | fulltext |
| identifier | ISSN: 0266-4623 |
| ispartof | International journal of technology assessment in health care, 2015-01, Vol.31 (4), p.207-209 |
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| language | eng |
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| source | Cambridge core; MEDLINE |
| subjects | Agreements Clinical outcomes Clinical trials Collaboration Commerce Costs Decision making Disease management Economic analysis Excitation Government Regulation Government regulations Health Health care Hospitals Innovations Mars Medical imaging Patients Policies Policy Making Regulators Regulatory approval Sleep Studies Technological change Technology Technology adoption Technology assessment Technology Assessment, Biomedical Theme Submissions Time Factors Tomography User training |
| title | EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES |
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