Clinical Data Collection - Paper vs. Electronic Data Capture (EDC)

Transcription

1 Clinical Data Cllectin - Paper vs. Electrnic Data Capture (EDC) Patrick Tuminar C.E.O Sftware Dynamics 20 years ag experts predicted that electrnic case reprt frms (CRFs) wuld replace paper as a natural cnsequence f the intrductin f cmputers. In 1997, the FDA prduced the regulatins that wuld guide the industry thrugh this transitin (CFR Title 21 Part 11). Still, 10 years hence, recent analyst research has identified that nly 30% f nging clinical trials are cnducted using EDC. Justificatin fr this slw acceptance has cme frm many varied surces. Just what are Spnsrs lking fr in a cmpany that prduces clinical trial sftware (Electrnic Data Capture r EDC)? The fllwing are the mst paramunt issues: 1. Glbal Scalability - The stage fr the majrity f clinical trials is glbal; a vendr cmpany needs the infrastructure t supprt this, and the EDC applicatin must be adaptable and able t expand t the needs f the prtcl. 2. Experience - Because failure is nt an ptin in Medial Research, Spnsrs seek vendrs that have a prven track recrd. 3. Rbust, Reliable, and prven technlgy that is cmplemented by an excellent supprt prcesses. While there are currently as many as 150 cmpanies attempting t fill the vid in EDC applicatins, mst d nt ffer the full package f ptins that wuld be required t run all aspects f a clinical prtcl frm beginning t end. Additinally, the pharmaceutical cmpany needs t cnsider the demands required f the clinical prgram, and whether the applicatin can meet thse demands. Sme imprtant questins t cnsider are: Will the stakehlders in the cmpany accept the technlgy, and are they ready t mve ahead with it? Is the infrastructure stable enugh t cnduct EDC trials in all f the cuntries which have the desired patient ppulatins (these may ften include Central Eurpean r African/Asian cuntries)?

2 Hw is surce data verificatin managed in this envirnment? Hw will EDC affect the internal rganizatin? What is the pinin f the regulatry authrities f data cllected in this way? Is there a danger f data being rejected as nncmpliant? When will the cmpany see a return n its investment? Hw can this be measured when s many f the EDC benefits are qualitative rather than quantitative? EDC vs. Paper Pharmaceutical cmpanies have recgnized that changing t an EDC trial prcess invlves mving data cllectin frm a series f sequential tasks t a parallel prcess where live data analysis can be emplyed t bring abut the best results. A primary gal f ur wn Simplicity applicatin was t develp the functinality f the EDC system s that it is nt nly an applicatin that is able t capture clinical data, but can als be used fr review and analysis. EDC is able t prvide system functinality thrugh the use f high-speed cnnectins using the Internet, eliminating much f the burden that is assciated with site management. By cmparisn, the paper CRF was received in-huse and entered by ne data clerk and verified by anther. The paper clinical trial prcess was cnceived, designed, and refined ver scres f years using paper as the medium fr cllecting clinical data. Since all the prcedures and functinal rles that make up the clinical data prcess were structured arund paper, it nly makes sense that changing it in its entirety will prduce sme issues and take sme time. The primary radblck t a cmpletely "paperless" study cmes frm the prblem f surce dcumentatin. Using the paper methd, the investigatr recrds the patient data in the surce ntes r a pr frma f sme kind, and then enters it int the EDC system sme time later. "EDC duble data entry" is caused by the assumptin that a paper surce is needed fr nline EDC systems. In a recent survey cnducted by the industry grup EDM Frum, 4,840 investigatrs (bth experienced and name in EDC) sited this paradigm as the number ne barrier t wide scale use f EDC in their clinical trials. This issue will cntinue t divide the industry until glbal health care evlves t the pint where all patient data is stred electrnically in a validated system. Erg, tday's number ne issue t the prpagatin f EDC fr clinical trials becmes the ability t reduce the site burden f EDC and clinical trial cnduct in general.

3 Cnducting the Trial In rder t reslve this "final cnflict", we need t ask urselves these tw questins: 1: What data d we want t cllect fr ur clinical trials? 2: At what pint and frm whm d we want t cllect it? Naturally, the prtcl and therapeutic area under study primarily drive the first pint, but typical clinical data can be rughly divided int tw grups: 1. Physilgical data such as vital sign readings, labratry values, and medical histry. 2. Patient-reprted utcme (PRO) data such as symptm cunts, subjective pain analysis, and quality f life assessments. These tw categries histrically make up the typical clinical trial, with physilgical data accunting fr 75% and PRO 25%. In a clinical trial, the interactin between the investigatr and patient is limited t the visit, intervals between which can vary frm weeks t mnths. CRF s include questins such as "Hw have yu felt since the last visit?" r "Have yu experienced any pain since the last visit?" r "Have yu taken yur medicine at the crrect time?" As we all understand, it is difficult t recall this infrmatin ver lng perids f time, s the patient is asked t recrd this infrmatin in a paper-based patient diary they use at hme. The cncept is that the infrmatin recrded at the medical mment will therefre increase its accuracy. There is legitimate cncern that while PRO data clearly cntributes imprtant infrmatin t the NDA, paper diaries prduce data that is ntriusly pr (as anyne with a backgrund in clinical trials will tell yu). Patients frget t cmplete the diary at the crrect time, and ften back r frward fill the diary. Cnsidering that this methd is being used t assess primary and secndary endpints, it's a serius cncern that the majrity f this data is at best irrelevant and at wrst fraudulent. The Future - Electrnic Patient Diaries (EPDs) One slutin, which interfaces well with EDC, is Electrnic Patient Diaries. EPD's can cntribute well t the verall success f a clinical trial. Instead f using a paper diary, the patient enters data directly int a mbile device. The EPD actively reminds patients t be prtcl-cmpliant regarding when they fill in the diary, instead f filling in the diary data just befre seeing the investigatr. S hw, yu may ask, can electrnic patient diaries reduce the site burden f EDC? In ne nging study with ver 5000 patients in 23 cuntries, EPD's will cllect ver 2,000,000 pages f data. The current level f cmpliance in the study is a remarkable 97%, and the level f accuracy represents a great imprvement ver paper. This type f wide scale study is a testament t the ability f EDC t cllect and accurately manage data n an enrmus scale, and is a perfect

4 example f hw EDC can lead sites t embrace the technlgy. Imagine having t recncile and cllect all that data using paper? Additinal key benefits frm EPD's include: 1. Screening assessment using EPDs - In a bid t recruit the crrect patients the first time and reduce drput, the EPD was used t screen patients. At the screening visit fllwing the preliminary assessment by the investigatr, each patient was given an EPD and asked t cmplete the diary during his r her daily rutine. During the screening perid the data is transmitted t the central. The Web-based reviewer tl runs a series f algrithms against the data t calculate the eligibility f the patient. At the next visit, the investigatr can then mve eligible patients t the next phase f the study, r retrieve the EPD frm ineligible patients and enrll anther rund. This dense data sampling is anticipated t reduce the required number f patients, which translates int a great time benefit. 2. Online prtcl amendments. The EPD technlgy supprts the nline prtcl amendments, which can be sent t the patients' EPDs t allw flexible rule adjustments. It was nticed at the beginning f ne study that the level f screening failures was higher than expected. On clser examinatin, ne f the inclusin criteria was inapprpriate in this patient ppulatin. An amendment was made, and the level f randmized patients increased. This meant that the trial culd be practively, rather than reactively, managed. 3. Reduced site administratin. The trial cnsisted f several cmplex phase and dsing transitins, which wuld have nrmally placed an additinal burden n the site fr the duratin f the trial. With the intelligent use f EPDs and rules running acrss the Web-based reviewer tl, the site culd use the technlgy t help administer the patients and their treatment. 4. Cst-neutral peratin. Once a patient had cmpleted the study, the EPD culd be recycled and given t the next patient recruited. There was n need fr the EPD t be returned t the vendr fr cnfiguratin, since this was all managed n-site. As a direct result, the investment required t purchase the devices can be amrtized acrss the study t create a cst-neutral peratin. 5. EPDs can be used t cllect critical PRO data directly frm the patient. The patients are allwed t set the alarms and trigger diary reminders, giving them the ability t fit the diaries int their lifestyle. The data transmitted frm each patient is sent t a secure server and made available fr patient management and administratin. Althugh the sites need t manage the EPDs and keep the batteries charged, the technlgy reduces the verall levels f site administratin and wrklad fr the trial.

5 Ging, Ging... Simplicity can be cmbined with EPD's t prduce cnsiderable benefits fr all factins invlved in a clinical trial. Fr the patient, the primary data capture pint is fcused upn them. Rather than being a burden, this allws flexibility in the way their data is captured and, in the future, may lead t tailred treatment. Fr the site, the level f EDC data entry is significantly reduced, and the EPD data is available nline. This adds value by allwing the site persnnel t fulfill their main bjective-individualized and imprved patient care. As was seen in the case study earlier in this article, sites can see and feel the benefits f using this technlgy. As with the adptin and acceptance f any new technlgy, if the end-users can see the benefits in their daily rutine, the level f adptin will increase as a natural cnsequence. Fr the spnsr there are many benefits. Use f EPD's and EDC delivers quality data faster. This methd f data capture brings the patient in t the center f the trial, thus creating a windw int the patients' lives by allwing practive interventin and trial management based n the real-time access t data. This mre effective trial management has demnstrated significant financial benefits by decreasing drput rates, speeding trial cmpletin, and allwing data-driven decisin-making at prgram, trial, site and patient levels. This will autmatically lead t a reductin in the number f mnitring visits and will actually increase the level f practive trial management. Data cllectin and management wrklad will be reduced and prductivity will increase with n decline in data quality. In Summatin At Sftware Dynamics, ur gal is t prvide spnsrs with the cutting edge technlgy required t efficiently run clinical trials, frm start t finish. Sftware Dynamics makes it easy fr Spnsrs t ease int new technlgy by rganizing it in a mdular fashin. Simplicity can be made t fit any study, and can easily migrate data frm ne phase t anther. Spnsrs new t EDC can select t have the prgram include (r exclude) any number f ptins t fit their need and budget. As new methdlgy f data cllectin becmes available, Sftware Dynamics will cntinue with whatever R&D is necessary t maintain ur technlgical lead in the industry. Patrick Tuminar C.E.O. Sftware Dynamics