Sökning: WFRF:(Guchelaar Henk Jan)
> (2020-2023) >
Generating evidence...
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van der Wouden, Cathelijne H.Leiden Univ, Dept Clin Pharm & Toxicol, Med Ctr, POB 9600, NL-2300 RC Leiden, Netherlands.;Leiden Univ, Leiden Network Personalised Therapeut, Med Ctr, Leiden, Netherlands.
(författare)
Generating evidence for precision medicine : considerations made by the Ubiquitous Pharmacogenomics Consortium when designing and operationalizing the PREPARE study
- Artikel/kapitelEngelska2020
Förlag, utgivningsår, omfång ...
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2020
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electronicrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-419196
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-419196URI
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https://doi.org/10.1097/FPC.0000000000000405DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:144189978URI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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Objectives Pharmacogenetic panel-based testing represents a new model for precision medicine. A sufficiently powered prospective study assessing the (cost-)effectiveness of a panel-based pharmacogenomics approach to guide pharmacotherapy is lacking. Therefore, the Ubiquitous Pharmacogenomics Consortium initiated the PREemptive Pharmacogenomic testing for prevention of Adverse drug Reactions (PREPARE) study. Here, we provide an overview of considerations made to mitigate multiple methodological challenges that emerged during the design.Methods An evaluation of considerations made when designing the PREPARE study across six domains: study aims and design, primary endpoint definition and collection of adverse drug events, inclusion and exclusion criteria, target population, pharmacogenomics intervention strategy, and statistical analyses.Results Challenges and respective solutions included: (1) defining and operationalizing a composite primary endpoint enabling measurement of the anticipated effect, by including only severe, causal, and drug genotype-associated adverse drug reactions; (2) avoiding overrepresentation of frequently prescribed drugs within the patient sample while maintaining external validity, by capping drugs of enrolment; (3) designing the pharmacogenomics intervention strategy to be applicable across ethnicities and healthcare settings; and (4) designing a statistical analysis plan to avoid dilution of effect by initially excluding patients without a gene–drug interaction in a gatekeeping analysis.Conclusion Our design considerations will enable quantification of the collective clinical utility of a panel of pharmacogenomics-markers within one trial as a proof-of-concept for pharmacogenomics-guided pharmacotherapy across multiple actionable gene–drug interactions. These considerations may prove useful to other investigators aiming to generate evidence for precision medicine.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Bohringer, StefanLeiden Univ, Dept Biomed Data Sci, Med Ctr, Leiden, Netherlands.
(författare)
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Cecchin, ErikaNatl Canc Inst, Ctr Riferimento Oncol Aviano CRO, Expt & Clin Pharmacol, Aviano, Italy.
(författare)
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Cheung, Ka-ChunRoyal Dutch Pharmacists Assoc KNMP, Med Informat Ctr, The Hague, Netherlands.
(författare)
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Lucia Davila-Fajardo, CristinaSan Cecilio Univ Hosp, Inst Invest Biosanitaria Granada, Dept Clin Pharm, IbsGranada, Granada, Spain.
(författare)
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Deneer, Vera H. M.Univ Med Ctr Utrecht, Dept Clin Pharm, Div Labs Pharm & Biomed Genet, Utrecht, Netherlands.
(författare)
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Dolzan, VitaUniv Ljubljana, Fac Med, Inst Biochem, Pharmacogenet Lab, Ljubljana, Slovenia.
(författare)
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Ingelman-Sundberg, MagnusKarolinska Institutet
(författare)
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Jonsson, SivKarolinska Inst, Dept Physiol & Pharmacol, Sect Pharmacogenet, Stockholm, Sweden.
(författare)
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Karlsson, MatsUppsala universitet,Institutionen för farmaceutisk biovetenskap(Swepub:uu)matskarl
(författare)
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Kriek, MarjoleinLeiden Univ, Dept Clin Genet, Med Ctr, Leiden, Netherlands.
(författare)
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Mitropoulou, ChristinaThe Golden Helix Fdn, London, England.
(författare)
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Patrinos, George P.Univ Patras, Sch Hlth Sci, Dept Pharm, Univ Campus, Patras, Greece.
(författare)
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Pirmohamed, MunirUniv Liverpool, Dept Mol & Clin Pharmacol, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.
(författare)
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Rial-Sebbag, EmmanuelleUMR 1027 Inserm, Toulouse, France.;Univ Toulouse III Paul Sabatier, Toulouse, France.
(författare)
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Samwald, MatthiasMed Univ Vienna, Ctr Med Stat Informat & Intelligent Syst, Vienna, Austria.
(författare)
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Schwab, MatthiasDr Margarete Fischer Bosch Inst Clin Pharmacol, Dept Clin Pharmacol, Stuttgart, Germany.;Univ Tubingen, Tubingen, Germany.;Univ Hosp Tubingen, Dept Clin Pharmacol, Tubingen, Germany.;Univ Tubingen, Dept Pharm & Biochem, Tubingen, Germany.
(författare)
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Steinberger, DanielaBiologis Ctr Human Genet, Frankfurt, Germany.;Justus Liebig Univ Giessen, Inst Human Genet, Giessen, Germany.
(författare)
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Stingl, JuliaRhein Westfal TH Aachen, Univ Hosp, Inst Clin Pharmacol, Aachen, Germany.
(författare)
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Sunder-Plassmann, GereMed Univ Venna, Dept Internal Med 3, Div Nephrol & Dialysis, Vienna, Austria.
(författare)
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Toffoli, GiuseppeNatl Canc Inst, Ctr Riferimento Oncol Aviano CRO, Expt & Clin Pharmacol, Aviano, Italy.
(författare)
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Turner, Richard M.Univ Liverpool, Dept Mol & Clin Pharmacol, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.
(författare)
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van Rhenen, Mandy H.Royal Dutch Pharmacists Assoc KNMP, Med Informat Ctr, The Hague, Netherlands.
(författare)
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van Zwet, ErikLeiden Univ, Dept Biomed Data Sci, Med Ctr, Leiden, Netherlands.
(författare)
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Swen, Jesse J.Leiden Univ, Dept Clin Pharm & Toxicol, Med Ctr, POB 9600, NL-2300 RC Leiden, Netherlands.;Leiden Univ, Leiden Network Personalised Therapeut, Med Ctr, Leiden, Netherlands.
(författare)
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Guchelaar, Henk-JanLeiden Univ, Dept Clin Pharm & Toxicol, Med Ctr, POB 9600, NL-2300 RC Leiden, Netherlands.;Leiden Univ, Leiden Network Personalised Therapeut, Med Ctr, Leiden, Netherlands.
(författare)
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Leiden Univ, Dept Clin Pharm & Toxicol, Med Ctr, POB 9600, NL-2300 RC Leiden, Netherlands.;Leiden Univ, Leiden Network Personalised Therapeut, Med Ctr, Leiden, Netherlands.Leiden Univ, Dept Biomed Data Sci, Med Ctr, Leiden, Netherlands.
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Pharmacogenetics & Genomics30:6, s. 131-1441744-68721744-6880
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van der Wouden, ...
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Bohringer, Stefa ...
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Cecchin, Erika
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Cheung, Ka-Chun
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Lucia Davila-Faj ...
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Deneer, Vera H. ...
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Dolzan, Vita
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Ingelman-Sundber ...
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Jonsson, Siv
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Karlsson, Mats
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Kriek, Marjolein
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Mitropoulou, Chr ...
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Patrinos, George ...
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Pirmohamed, Muni ...
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Rial-Sebbag, Emm ...
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Samwald, Matthia ...
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Schwab, Matthias
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Steinberger, Dan ...
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Stingl, Julia
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Sunder-Plassmann ...
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Toffoli, Giusepp ...
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Turner, Richard ...
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van Rhenen, Mand ...
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van Zwet, Erik
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Swen, Jesse J.
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Guchelaar, Henk- ...
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