Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials
Abstract
:1. Introduction
2. Details of Included Trials
3. TARGET
4. EU-PACT
5. SHIVA
6. GGST Statin Trial
7. Precision Medicine Guided Treatment for Cancer Pain
8. Discussion
Recommendations
- -
- Systematic review before embarking on a trial
- -
- Guidelines are required
Supplementary Materials
Author Contributions
Funding
Conflicts of Interest
References
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Registration Number | Trial Name | Start Year | Year of Results Publication | Paper References Taken from | BM Trial Design | Biomarker | Drug of Interest | Sample Size (n Randomised) | Age of Participants | Sex of Participants | Ethnicity of Participants | Study Location |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ISRCTN30748308 | TARGET (protocol) [10,47] | 2005 | 2011 | 2005 protocol obtained from authors | Biomarker strategy design (without biomarker assessment in control arm) | TPMT | Azathioprine | 333 | Mean 43.2 (control) | 50.6%/49.4% F/M (control) | 92.2% white, 4.8% South Asian, 0.6% Black, 2.4% mixed/other (control) | UK |
Mean 41.0 (genotyped) | 50.3%/49.7% F/M (genotyped) | 89.8% white, 7.2% South Asian, 3.0% Black, 0% mixed/other (genotyped) | ||||||||||
NCT01119300 | EU-PACT [49] | 2011 | 2013 | 2009 paper 10.2217/pgs.09.125 | Biomarker strategy design (without biomarker assessment in control arm) | CYP2C9*2 | Warfarin | 455 | Mean 66.9 (control) | 42.1%/57.9% F/M (control) | 98.7% white, 0.9% Black, 0.4% Asian (control) | UK, Sweden |
CYP2C9*3 | Mean 67.8 (genotyped) | 35.8%/64.2% F/M (genotyped) | 98.2% white, 1.3% Black, 0.4% Asian (genotyped) | |||||||||
VKORC1 | ||||||||||||
NCT01771458 | SHIVA [43] (protocol) | 2012 | 2015 | 2014 protocol obtained from authors | Enrichment design | Hormone receptors pathway | Targeted chemotherapy agent, based on genotyping | 195 | Median 63 (control) | 72%/28% F/M (control) | Not reported | France |
PI3K/AKT/mTOR pathway | Median 61 (genotyped) | 61%/39% F/M (genotyped) | ||||||||||
RAF/MEK pathway | ||||||||||||
NCT01894230 | GGST statin trial [44] | 2013 | 2018 | 2016 paper 10.2217/pgs-2016-0065 | Biomarker strategy design (with biomarker assessment in control arm) | SLCO1B1*5 | Any statin | 159 | Mean 62.5 (control) | 65.8%/34.2% F/M (control) | 80.3% white, 14.5% Black, 5.3% other (control) | USA |
Mean 62.7 (genotyped) | 49.4%/50.6% F/M (genotyped) | 79.5% white, 16.9% Black, 3.6% other (genotyped) | ||||||||||
NCT02664350 | n/a [46] | 2016 | Results not yet published | 2018 paper 10.1016/j.cct.2018.03.001 | Biomarker strategy design (without biomarker assessment in control arm) | CYP2D6 | Opioids | 200 (forecast) | Not available | Not available | Not available | USA |
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Johnson, D.; Hughes, D.; Pirmohamed, M.; Jorgensen, A. Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials. J. Pers. Med. 2019, 9, 42. https://doi.org/10.3390/jpm9030042
Johnson D, Hughes D, Pirmohamed M, Jorgensen A. Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials. Journal of Personalized Medicine. 2019; 9(3):42. https://doi.org/10.3390/jpm9030042
Chicago/Turabian StyleJohnson, Danielle, Dyfrig Hughes, Munir Pirmohamed, and Andrea Jorgensen. 2019. "Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials" Journal of Personalized Medicine 9, no. 3: 42. https://doi.org/10.3390/jpm9030042