“It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial
Adaptive pragmatic clinical trials offer an innovative approach that integrates clinical care and research. Yet, blurring the boundaries between research and clinical care raises questions about how clinicians and investigators balance their patient care and research roles and what types of knowledg...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2022-07-01
|
| Series: | New Genetics and Society |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/14636778.2022.2115348 |
| _version_ | 1797681260627230720 |
|---|---|
| author | Jennifer Elyse James Galen Joseph |
| author_facet | Jennifer Elyse James Galen Joseph |
| author_sort | Jennifer Elyse James |
| collection | DOAJ |
| description | Adaptive pragmatic clinical trials offer an innovative approach that integrates clinical care and research. Yet, blurring the boundaries between research and clinical care raises questions about how clinicians and investigators balance their patient care and research roles and what types of knowledge and risk assessment are most valued. This paper presents findings from an ethnographic ELSI (Ethical, Legal, Social Implications) study of an innovative clinical trial of risk-based breast cancer screening that utilizes genomics to stratify risk and recommend a breast cancer screening schedule commensurate with the assessed risk. We argue that the trial demonstrates a fundamental tension between the promissory ideals of personalized medicine, and the reality of implementing risk-stratified care on a population scale. We examine the development of a Screening Assignment Review Board in response to this tension which allows clinician-investigators to negotiate, but never fully resolve, the inherent contradiction of “precision population screening.” |
| first_indexed | 2024-03-11T23:41:54Z |
| format | Article |
| id | doaj.art-be5e0b50f2174cb6ae61e59efcba4391 |
| institution | Directory Open Access Journal |
| issn | 1463-6778 1469-9915 |
| language | English |
| last_indexed | 2024-03-11T23:41:54Z |
| publishDate | 2022-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | New Genetics and Society |
| spelling | doaj.art-be5e0b50f2174cb6ae61e59efcba43912023-09-19T15:22:19ZengTaylor & Francis GroupNew Genetics and Society1463-67781469-99152022-07-0141322825310.1080/14636778.2022.21153482115348“It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trialJennifer Elyse James0Galen Joseph1University of CaliforniaUniversity of CaliforniaAdaptive pragmatic clinical trials offer an innovative approach that integrates clinical care and research. Yet, blurring the boundaries between research and clinical care raises questions about how clinicians and investigators balance their patient care and research roles and what types of knowledge and risk assessment are most valued. This paper presents findings from an ethnographic ELSI (Ethical, Legal, Social Implications) study of an innovative clinical trial of risk-based breast cancer screening that utilizes genomics to stratify risk and recommend a breast cancer screening schedule commensurate with the assessed risk. We argue that the trial demonstrates a fundamental tension between the promissory ideals of personalized medicine, and the reality of implementing risk-stratified care on a population scale. We examine the development of a Screening Assignment Review Board in response to this tension which allows clinician-investigators to negotiate, but never fully resolve, the inherent contradiction of “precision population screening.”http://dx.doi.org/10.1080/14636778.2022.2115348personalized medicinerisk-stratificationrisk-based screeningbreast cancer screeningpragmatic adaptive trial designgenomicsethnographyembedded elsi |
| spellingShingle | Jennifer Elyse James Galen Joseph “It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial New Genetics and Society personalized medicine risk-stratification risk-based screening breast cancer screening pragmatic adaptive trial design genomics ethnography embedded elsi |
| title | “It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial |
| title_full | “It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial |
| title_fullStr | “It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial |
| title_full_unstemmed | “It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial |
| title_short | “It’s personalized, but it’s still bucket based”: the promise of personalized medicine vs. the reality of genomic risk stratification in a breast cancer screening trial |
| title_sort | it s personalized but it s still bucket based the promise of personalized medicine vs the reality of genomic risk stratification in a breast cancer screening trial |
| topic | personalized medicine risk-stratification risk-based screening breast cancer screening pragmatic adaptive trial design genomics ethnography embedded elsi |
| url | http://dx.doi.org/10.1080/14636778.2022.2115348 |
| work_keys_str_mv | AT jenniferelysejames itspersonalizedbutitsstillbucketbasedthepromiseofpersonalizedmedicinevstherealityofgenomicriskstratificationinabreastcancerscreeningtrial AT galenjoseph itspersonalizedbutitsstillbucketbasedthepromiseofpersonalizedmedicinevstherealityofgenomicriskstratificationinabreastcancerscreeningtrial |