eprintid: 10066634 rev_number: 16 eprint_status: archive userid: 608 dir: disk0/10/06/66/34 datestamp: 2019-02-14 18:02:38 lastmod: 2021-12-18 23:46:07 status_changed: 2019-02-14 18:02:38 type: article metadata_visibility: show creators_name: Hordern, J creators_name: Maughan, T creators_name: Feiler, T creators_name: Morrell, L creators_name: Horne, R creators_name: Sullivan, R title: The 'molecularly unstratified' patient: a focus for moral, psycho-social and societal research ispublished: pub divisions: UCL divisions: B02 divisions: C08 divisions: D10 divisions: G11 keywords: Molecularly unstratified patients · Research ecosystems · Cancer · Biomarkers · Molecularly targeted therapies · Demoralisation · Patient perceptions note: This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND) (http://www.karger.com/Services/OpenAccessLicense). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. https://creativecommons.org/licenses/by-nc-nd/4.0/ abstract: The biomedical paradigm of personalised precision medicine - identification of specific molecular targets for treatment of an individual patient - offers great potential for treatment of many diseases including cancer. This article provides a critical analysis of the promise, the hype and the pitfalls attending this approach. In particular, we focus on 'molecularly unstratified' patients - those who, for various reasons, are not eligible for a targeted therapy. For these patients, hope-laden therapeutic options are closed down, leaving them left out, and left behind, bobbing untidily about in the wake of technological and scientific 'advance'. This process creates a distinction between groups of patients on the basis of biomarkers and challenges our ability to provide equitable access to care for all patients. In broadening our consideration of these patients to include the research ecosystem that shapes their experience, we hypothesise that the combination of immense promise with significant complexity creates particular individual and organisational challenges for researchers. The novelty and complexity of their research consumes high levels of resource, possibly in parallel with undervaluing other 'low hanging fruit', and may be challenging current regulatory thinking. We outline future research to consider the societal, psycho-social and moral issues relating to 'molecularly unstratified' patients, and the impact of the drive towards personalisation on the research, funding, and regulatory ecosystem. date: 2017-11 date_type: published official_url: https://doi.org/10.1159/000480422 oa_status: green full_text_type: pub pmcid: PMC6314434 language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1621286 doi: 10.1159/000480422 lyricists_name: Horne, Robert lyricists_id: RHORN95 actors_name: Horne, Robert actors_name: Harris, Jean actors_id: RHORN95 actors_id: JAHAR68 actors_role: owner actors_role: impersonator full_text_status: public publication: Biomedicine Hub volume: 2 number: Suppl 1 article_number: 480422 event_location: Switzerland issn: 2296-6862 citation: Hordern, J; Maughan, T; Feiler, T; Morrell, L; Horne, R; Sullivan, R; (2017) The 'molecularly unstratified' patient: a focus for moral, psycho-social and societal research. Biomedicine Hub , 2 (Suppl 1) , Article 480422. 10.1159/000480422 <https://doi.org/10.1159/000480422>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10066634/1/480422.pdf