Preprint Article Version 2 This version is not peer-reviewed

New Non-Validated Practice: An Enhanced Definition of Innovative Practice for Medicine

Version 1 : Received: 2 May 2019 / Approved: 7 May 2019 / Online: 7 May 2019 (05:02:54 CEST)
Version 2 : Received: 28 October 2019 / Approved: 29 October 2019 / Online: 29 October 2019 (17:04:12 CET)

How to cite: Mastroleo, I.; Holzer, F. New Non-Validated Practice: An Enhanced Definition of Innovative Practice for Medicine. Preprints 2019, 2019050070 (doi: 10.20944/preprints201905.0070.v2). Mastroleo, I.; Holzer, F. New Non-Validated Practice: An Enhanced Definition of Innovative Practice for Medicine. Preprints 2019, 2019050070 (doi: 10.20944/preprints201905.0070.v2).

Abstract

A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term innovation with the more literal of new non-validated practice. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonization of its regulation and legislation (e.g. right-to-try laws).

Subject Areas

right to try; innovation in medicine; innovative care; innovative practice; distinction between research and practice

Comments (2)

Comment 1
Received: 29 October 2019
Commenter: Ignacio Mastroleo
Commenter's Conflict of Interests: Author
Comment: This version modifies the title, abstract, introduction and updates the bibliography. Adds acknowledgments and minor modifications in the rest of the manuscript.
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Response 1 to Comment 1
Received: 29 October 2019
Commenter: Ignacio Mastroleo
The commenter has declared there is no conflict of interests.
Comment: The current article has been accepted for publication in Law, Innovation and Technology www.tandfonline.com/toc/rlit20/current (Q1 Scimago) vol. 12, issue 2, on 24 October 2019. Unfortunately the journal has a delay of 12 months of publication and not online first.

Please quote as follows:

Mastroleo, I., & Holzer, F. (2020). New non-validated practice: an enhanced definition of innovative practice for medicine. Law, Innovation and Technology, 12(2), preprint, https://doi.org/10.20944/preprints201905.0070.v2

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