Clinical trials in the age of personalized medicine

Keating, Peter; Cambrosio, Alberto

doi:10.1007/s12682-011-0094-6

Cited by 4 publications

(3 citation statements)

References 57 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Section: Introductionmentioning

confidence: 99%

“…These types respond to different treatments, and experimental and translational cancer research are woven together with standard cancer care in ways that have become more complex since the '-omics revolution'. (Keating and Cambrosio 2007, 2011, 2012a, 2012b Breast tumours are staged according to their size and anatomical spread, and graded by histological appearance; molecular typing improves estimates of prognosis and the likely benefits of different therapies. Subtyping includes histological grade, the expression of hormone receptors (oestrogen and progesterone) and the amplification status of the HER2 gene.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Stratified, precision or personalised medicine? Cancer services in the ‘real world’ of a London hospital

Day

Coombes

McGrath-Lone

et al. 2016

Sociology Health & Illness

View full text Add to dashboard Cite

We conducted ethnographic research in collaboration with a large, researchintensive London breast cancer service in 2013-2014 so as to understand the practices and potential effects of stratified medicine. Stratified medicine is often seen as a synonym for both personalised and precision medicine but these three terms, we found, also related to distinct facets of treatment and care. Personalised medicine is the term adopted for the developing 2016 NHS England Strategy, in which breast cancer care is considered a prime example of improved biological precision and better patient outcomes. We asked how this biologically stratified medicine affected wider relations of care and treatment. We interviewed formally 33 patients and 23 of their carers, including healthcare workers; attended meetings associated with service improvements, medical decision-making, public engagement, and scientific developments as well as following patients through waiting rooms, clinical consultations and other settings. We found that the translation of new protocols based on biological research introduced further complications into an already-complex patient pathway. Combinations of new and historic forms of stratification had an impact on almost all patients, carers and staff, resulting in care that often felt less rather than more personal.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stratified, precision or personalised medicine? Cancer services in the ‘real world’ of a London hospital

Day

Coombes

McGrath-Lone

et al. 2016

Sociology Health & Illness

View full text Add to dashboard Cite

show abstract

“…We disagree, not least because the new clinic is part of an ongoing, broader shift that involves a major rethinking of the basic characteristics of clinical trials (e.g. Keating and Cambrosio 2011, Nelson et al 2014, Sharpless and Doroshow 2019.…”

Section: Resultsmentioning

confidence: 99%

Genomic expertise in action: molecular tumour boards and decision‐making in precision oncology

Bourret

Cambrosio

2019

Sociology Health & Illness

Self Cite

View full text Add to dashboard Cite

The recent development of cancer precision medicine is associated with the emergence of ‘molecular tumour boards’ (MTBs). Attended by a heterogenous set of practitioners, MTBs link genomic platforms to clinical practices by establishing ‘actionable’ connections between drugs and molecular alterations. Their activities rely on a number of evidential resources – for example databases, clinical trial results, basic knowledge about mutations and pathways – that need to be associated with the clinical trajectory of individual patients. Experts from various domains are required to master and align diverse kinds of information. However, rather than examining MTBs as an institution interfacing different kinds of expertise embedded in individual experts, we argue that expertise is the emergent outcome of MTBs, which can be conceptualised as networks or ‘agencements’ of humans and devices. Based on the ethnographic analysis of the activities of four clinical trial MTBs (three in France and an international one) and of two French routine‐care MTBs, the paper analyses how MTBs produce therapeutic decisions, centring on the new kind of expertise they engender. The development and activities of MTBs signal a profound transformation of the evidentiary basis and processes upon which biomedical expertise and decision‐making in oncology are predicated and, in particular, the emergence of a clinic of variants.

show abstract

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Campbell

King

2017

BioSocieties

View full text Add to dashboard Cite

The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn attention to its endorsement of so-called 'enrichment strategies' for streamlining clinical trials. Among these is 'enriched enrollment randomized withdrawal' (EERW), a design intended to improve measures of drug efficacy by screening out patients who are non-responsive or suffer adverse effects. EERW has been promoted as a response to the problem of high trial failure rates for drugs that were previously thought to be effective for pain management. This article uses EERW as a window into the evidentiary politics of pain medicine in the twenty-first century, against the backdrop of concerns about prescription opioid abuse. We demonstrate that the reframing of negative trials as 'failed' trials poses a challenge to the evidence hierarchy of evidence-based medicine, and identify several rhetorical strategies used by proponents to normalize EERW by placing it in continuity with routine clinical trial practice and the promise of personalized medicine. Finally, we illustrate how EERW, in the current regulatory context, fails to contribute to the individualization of diagnosis or therapy, and reinforces the perceived gulf between trials for regulatory approval and clinical practice.

show abstract

Clinical trials in the age of personalized medicine

Cited by 4 publications

References 57 publications

Stratified, precision or personalised medicine? Cancer services in the ‘real world’ of a London hospital

Stratified, precision or personalised medicine? Cancer services in the ‘real world’ of a London hospital

Genomic expertise in action: molecular tumour boards and decision‐making in precision oncology

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Contact Info

Product

Resources

About