Beresniak, Ariel

De Moor, Georges

Dupont, Danielle

Kalra, Dipak

Schmidt, Andreas

Sundgren, Mats

BioMed Research International

English

PubMed

Ariel Beresniak

Andreas Schmidt

Danielle Dupont

Mats Sundgren

Dipak Kalra

Georges J. E. De Moor

Crossref

Improving Performance of Clinical Research: Development and Interest of Electronic Health Records

Ghent University Academic Bibliography

EditorialImproving Performance of Clinical Research:Development and Interest of Electronic Health RecordsAriel Beresniak,1 Andreas Schmidt,2 Danielle Dupont,3 Mats Sundgren,4Dipak Kalra,5 and Georges J. E. De Moor61Data Mining International, Geneva, Switzerland2Andreas Schmidt with Innovation Management, Product Development, F. Hoffmann-Laroche Ltd., Basel, Switzerland3Data Mining America, Montreal, Canada4AstraZeneca, Molndal, Sweden5University College London, London, UK6University of Ghent, Ghent, BelgiumCorrespondence should be addressed to Ariel Beresniak; aberesniak@datamining-international.comReceived 23 August 2015; Accepted 25 August 2015Copyright © 2015 Ariel Beresniak et al.This is an open access article distributed under the Creative Commons Attribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Collecting health information from patients is probably oneof the most ancient medical acts. The Hippocratic Corpuswas a compendium of medical records from Ancient Greeceand one of the first attempts to classify diseases according tosymptoms and observations.Over the years, health records have been mainly used inpaper format to document individual patient characteristics,to keep track of treatments, and to report patient outcomes.Nowadays, as medical care is gettingmore andmore complexand personalized, the recent advances and uses of infor-mation technologies enable capturing, processing, storing,and mining patient-level data in order to quickly extractmeaningful clinical information and medical knowledge forclinical decision making and to further personalize healthcare. With their widespread use, Electronic Health Records(EHRs) have become a very important tool from whichnew services can be provided. This major breakthrough isalready starting to transform research and development ofinnovative health products by enhancing and speeding upexisting processes. This is because EHR data can be used torapidly optimise clinical protocol designs, to better identifyand faster recruit eligible patients for clinical trials, and tofoster new, efficient ways of collecting data during clinicalstudy conduct and improve the detection and reporting ofserious adverse events.Despite available technologies, numerous challengesremainwhich still require significant efforts and time: ethical,legal, data privacy issues, information technology systemsintegration, optimal interoperability for a seamless and trust-worthy data exchange, and so forth.Importantly, major innovations such as developing bestin class and seamless EHR-enabled clinical data exchangesystems require building awareness and trust with multiplestakeholders in order to maximize the expected benefits,as well as societal acceptance from patients, health careproviders, governmental bodies, and clinical trial sponsors.In particular, clinical research investigators and sponsorshave long been using conventional clinical research processesthat rely more upon ad hoc case finding and ploughingthrough large numbers of paper records. They will thusrequire special attention, including the development anddissemination of customized value propositions that explainand evidence innovative EHR-based clinical research plat-forms, how these compare with existing practices, and whichqualitative and quantitative benefits they can deliver in orderto facilitate adoption and large scale implementation.Hindawi Publishing CorporationBioMed Research InternationalVolume 2015, Article ID 864549, 2 pageshttp://dx.doi.org/10.1155/2015/8645492 BioMed Research InternationalEHRs offer an unprecedented opportunity, as well as tech-nological challenges, to change the current clinical researchparadigm, including the following:(1) Patient databases are growing rapidly and are becom-ing more accessible.(2) The diversity of health records is important, coveringall kinds of populations and health conditions.(3) EHRs are heterogeneous, which makes interoper-ability (seamless data exchange) and integration ofinformation a challenging task.(4) For a particular reuse of EHRs, only a selection of keyparameters (data items) might be useful for clinicalresearch.(5) EHRs are dynamic: the monitoring of the changescould become important features for many researchapplications.(6) The use of EHR data for clinical research could speedup the patient recruitment phase, reduce the numberof protocol amendments, improve the efficiency ofmajor parts of the clinical trial process, and reducecosts.(7) EHRs offer many opportunities for data mining, suchas to extract original meaningful information from alarge set of patients or populations.Given the growing demand worldwide for clinical evi-dence (including from real-world contexts), as well as theformidable challenges in clinical research today (includingcostly protocol amendments, significant delays in patientrecruitment, time-consuming and redundant clinical dataentry in appropriate data management systems, and theescalation in research and development costs), the questionis not so much if clinical research will use these new conceptsin current practice and benefit from reusing EHR data, butwhen.As more and more applied research domains are nowexploring how to use electronic platforms to facilitate keyclinical research tasks, and considering the inexorable trendtowards modernising clinical research models to create,deliver, and capture more value and benefits, it appears tobe good timing to provide a scientific overview on the mostadvanced research and developments in this field in the frameof a special issue.This special issue provides an opportunity to presentthe latest scientific contributions and technological develop-ments in this emerging field that can be derived from theresearch use of EHR data.The objectives of this special issue are twofold:(1) For the first time, to bring together and to presentsome of the latest research and development efforts inthis field, including technological R&D, surveys, andpilot studies.(2) To support more and focused research activities inthis domain. Given the large number of clinical trialsworldwide, the next challenge will naturally be toensure a seamless and sustainable deployment ofthese advanced and trustworthy interoperable plat-forms in order to enable the reuse of EHR data at theglobal level.There is no doubt that the original articles published in thisspecial issue already evidence this emerging reality for thefuture of clinical research, thanks to the contributions of abroad number of highly experienced and specialized authorsin this field. The presented articles address a wide rangeof perspectives and compile the most promising researchfindings and the latest developments.As EHRs will continue to have a significant and posi-tive impact on state-of-the-art clinical development, we areconfident that this special issue will stimulate further ideasand research for enhancing, speeding up, and optimisingclinical research worldwide, towards delivering effective andsafe innovative medicines to health care faster, to the benefitsof patients, the entire health systems, and society.Ariel BeresniakAndreas SchmidtDanielle DupontMats SundgrenDipak KalraGeorges J. E. De Moor

Improving performance of clinical research : development and interest of electronic health records

https://biblio.ugent.be/publication/8511644/file/8511646

Improving performance of clinical research : development and interest of electronic health records

Abstract

Similar works

Full text

Available Versions

Crossref

Ghent University Academic Bibliography