Acceliant white paper_edc_and_epro


Published on

  • Be the first to comment

  • Be the first to like this

No Downloads
Total Views
On Slideshare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Acceliant white paper_edc_and_epro

  1. 1. Modular, Disparate, and Single-System Approaches to Collecting Data
  2. 2. IntroductionAs post-marketing studies are more prevalent today, the based architecture. The use of web-enabled technologiesFDA and pharmaceutical companies have taken greater support more complex and flexible trial designs2.interest in direct patient information1. For many yearsthis information was accumulated via traditional ePRO Overviewcollection methods, including paper forms and ePRO is simply the collection of data directly fromInteractive Voice Response Systems (IVRS). With the patients into a database. The concept is not new - withintroduction of the Internet and a plethora of mobile innovators like Health Hero Network and a variety ofdevices now in use, more advanced methods of handheld diary systems active in the market for the pastgathering data speed up data collection, improve data 20 years - but the adoption of ePRO technologies is stillquality, and rapidly merge with readily available emerging and undergoing scrutiny. At a recent ePROElectronic Data Capture (EDC) systems. These Electronic conference, an open discussion on ePRO methods wasPatient Reported Outcome (ePRO) systems are deployed characterized as a “volleyball match” 3. The developmentacross a wide range of platforms and solutions. Although and deployment of ePRO is still relatively new and ismodular and disparate systems are the norm, a single slowly replacing paper diaries, mailed forms, and IVRS.ePRO/EDC system offers a superior solution by allowing ePRO adoption comes at a time when smart phones,all study data to be readily available without incurring tablets, and the Internet are readily available to theintegration costs. This integrated implementation gives majority of the population. Internet availability in Northsponsors the ability to employ unified analysis strategies America currently stands at more than 75 percentin a timely manner with a significant reduction in cost. penetration4 and cellular phone penetration now stands at more than 80 percent for the same area5. With thisEDC Overview new technology study, sponsors are pushing the marketEDC systems have been in use for more than 20 years in towards an inevitable domination of ePRO6 to save time,a variety of data capture modalities. By having an money and improve data quality.investigator enter data directly into a clinical database,the normal steps of send and receive created by paperare eliminated. It was predicted that the use of EDC 7technologies would yield cleaner data and the sourcedata would be more readily apparent. EDC systemsbegan with terminal-based clients, progressing to thick-client applications and eventually to web-basedapplications. In past years, back-end databases rangedfrom Oracle and Microsoft’s SQL server to a variety ofhomegrown flat files including the flat file structures ofSAS datasets. A variety of system types and architecturesstill exist although as per last year’s review of EDCcompanies at the Drug Information Association (DIA)annual meeting, most companies had migrated to a web- Increasing Technology Usage Awareness in EDC and ePRO
  3. 3. Integration of Modular and Disparate SystemsAnyone searching the Internet or available journals will with two separate vendors. A series of edits or rangefind dozens of articles advocating the integration of EDC checks that could apply to both systems must beand ePRO data, providing sponsors exciting ways of programmed separately with no common sharingimplementing these integrations through new tools and mechanism. When the technologies are complete, therea series of seemingly never-ending database still may be integration challenges. Studies where patientmanipulations. Although this paper will not examine any visits trigger EDC data entry become more challenging asspecific integration it can be safely stated that data must be transferred between the two systems in aintegration of technology and clinical system is not a timely manner.simple matter. Approaches to integrate have generated The process of data integration can also add considerabledozens of whitepapers. From a validation perspective, complexity to any study. Usually, the data from multipleintegration involves a significant amount of testing, systems is combined inside a separate single-dataverification, and paperwork. warehouse repository with no clean cross reference toThe general approach of integrating modular or the source records or the source system. Again, unlesssystems can be less complex if planning begins early. The careful planning and execution is done, there would benecessity of a common data naming convention or at massive risks. A difficult and illusive risk to manage isleast well defined structure creates a series of import time. For example, when were both exports to the datamaps. These can be utilized to combine the two systems warehouse made? What are the common datainto a single clinical database and made readily available elements? Which data wins in the event of duplication?for statisticians. Some large pharmaceutical companies Is only clean data exported? What is the proper way tohave created massive data definition libraries to address handle data that is out of range? How is free-text dataintegration issues, although many other companies use handled9? Other such questions need to be asked andstandardized conventions (i.e. CDISC, CDASH8). answered in any type of data integration.Even with the completion of necessary data mapping, With a solid plan for integration, the necessity of provingneed for proper design, development, testing, and that each integration activity has produced the samevalidation still exists and can become costly unless result can be daunting, considering that regulations maycommunication and planning are well documented and be in effect10. A proper validation should consist offinely executed. Without the necessary proof that data multiple iterations to ensure the import is consistent.mapped to a particular system is being passed correctly it Another option may be to review documentation from ais possible that errors may get introduced into the clinical vendor that has validated its tools to minimize risk. Evendatabase, possibly creating significant risk to the if such documentation exists, it may still be necessary tosponsor. test the study data during the validation and UAT portion of study startup.Using multiple data-collection systems instantly has adirect impact on sponsors and study members as both The end result of integration, though potentiallysystems require setup. Even with modern setup tools the accurate, means additional cost as the systems orneed for setup time, constant communication, and modules are compared to the data warehouse.strong project management can have a financial impact.From a technology standpoint, the sponsor is basicallypaying to set up two complete data-collection systemsand under many circumstances, the sponsor is working
  4. 4. The Single-System ApproachWith the need for additional post-market studies and the The need for multiple vendors and additional consultantsnecessity for data to rapidly prove endpoints and publish, to design the integration methodology is also systems are being released which eliminate the The Acceliant eClinical Suite manages ePRO and EDC byinitial need for data integration. These systems represent defining an extra layer in eCRF setup. If a CRF is definedmultiple technologies that exist in a single as EDC, it uses a standard EDC display methodology andimplementation and share common definitions, such as is accessed via the EDC portal by sites, data managers,data access and data export. monitors, and other necessary users as defined by theAn example of a true single system is the Acceliant technology. If, however, the CRF is defined as ePRO, theeClinical Suite11 where multiple solutions are housed in a page is also accessible via an ePRO portal interface with asingle data warehouse and managed by a single more aesthetic look and feel as defined by the sponsor.interface. Utilizing the Unified Trial Builder (UTB), an Thus, forms that are patient facing are presented toexperienced data manager can design EDC, CRF, and patients with a very simplified interface, whereas theePRO data collection instruments that can be deployed same forms are available for other users as standard EDCquickly and efficiently. ePRO and EDC pages, being part forms. As they share the same database, updates to dataof the same data-definition table, eliminate the need for are in real time for both EDC and ePRO without an exportintegration. Consequently, costs are reduced in the areas or import of collected data.of validation in the management of multiple systems. Web Services Site Users Site Admin Patients ePRO Web HTTP / HTTPS System Admin Web Services Presentation Layer Web HTTP / HTTPS UI Process UI Component Component Study Data Business Logic Layer PHI User Data Service Agent
  5. 5. The ePRO portal allows patients to review predefined in both EDC and ePRO, allowing range checks to beinformation about the study, documents etc. that the applied to the variable in ePRO with a simple user action.sponsor has defined for the system and also to access The data collected from patients can function as a triggerpages as defined in the UTB for ePRO access. Because for more types of follow-up edits in the EDC portal. Datapatients access the ePRO portal, it can be used to collected from a patient may initiate an event, create aenhance the branding experience and can contain and query for the site to research, or begin a complex processdisseminate information that is necessary for patients. that creates reports or sends email notifications to theUpon activating the option, a physician and a patient can appropriate data manager or safety associate.communicate via the patient portal and the EDC portal Utilizing a single system like the Acceliant Clinical Trialthrough a convenient messaging system. Because certain Suite can also reduce validation costs. Instead of creatingfields can be marked for privacy by the designer, validation plans and running acceptance tests forconfidentiality is guaranteed as this data can be multiple systems, a single plan and acceptance testcompletely segregated in the database system or marked covers both EDC data and ePRO data and eliminates theas not exportable or even not viewable by certain users. need for integration validation.ePRO pages have more flexible controls such as sliders,pictographs, push buttons, and more to make the patient Conclusionexperience, for the same fields, as simple as possible. The necessary endpoint for any clinical trial, registry, or other type of study is data availability. With cost andThe EDC portal allows a clinical user or a site to enter time being critical factors in the implementation anddata, query standard data, or answer queries as defined execution of any type of data collection effort, the abilityin the study protocol. The sponsor or data manager also to combine systems in a single technology is a distincthas the ability to review more types of data, enter notes, advantage. During the next several years, the push forreview audit records, code data or review auto-coded more simple systems will be necessary to ensure qualitydata, upload or review documents, and generate and and cost-effective data. Although modular and disparatereview reports on data and the state of the system or systems are currently the norm, a single ePRO/EDCexport data. The powerful data-export system can create system offers a superior solution by allowing all studymultiple types of data exports ranging from Excel to SAS data to be readily available without incurring the costs ofdatasets along with complete data definitions. The data integration. This single implementation can give sponsorsexport is generated in real time and throttles against the the ability to create analysis in a timely manner and at adatabase so there are no lapses in accessibility for any lesser cost. Utilizing a single solution, sponsors can alsouser, ePRO or EDC, to the system. The EDC portal also reduce user frustration in their electronic studyhas a built-in messaging system, scheduling system, and implementations and achieve multiple successes within aother features that can assist site, sponsor, and data study implementation.manager in proper management of their study.To ensure data cleanliness all EDC and ePRO systemsutilize range checks and different types of edits. Edits inePRO are not as common, considering the data source isthe actual patient. However, range checks in thesesystems are prevalent to reduce patientmisunderstanding or data-entry errors. The AccelianteClinical Suite utilizes the same capabilities for variables
  6. 6. Reference and Research1. research supporting this white paper:1. http://appliedclinicaltrialsonline.findpharma.com3. Allen Smith:Andrew Smith has been designing IT solutions for more than 25 years. With a diverse career spanning multipleindustries, Andrew applies energy, experience, and education to create effective technology implementations. For thepast 13 years Andrew has been reviewing, designing, and maintaining clinical technologies. A frequent speaker at DrugInformation Association (DIA) meetings and other industry venues, Andrew is constantly looking at new technology andnew approaches in technology to address the changing needs of clinical research. Andrew was on the advisory councilfor the DIA for four years and continues to stay in touch with technology through special interest activity communitiesand other groups.Ven Thangaraj:With nearly 20 years of experience in the biomedical field, Ven Thangaraj, CTO, has been responsible for Acceliant sincethe platform’s inception. He partners with numerous clients in evaluations, deployment, and operations of clinical trialsusing Acceliant. He also consults for top management and data management clients at pharmaceutical, devicemanufacturers, CROs, and biotech companies on clinical trials from lab phase to all further stages of the lifecycle. Venearned a B.S. degree in biomedical engineering from the University of Illinois in Champaign-Urbana, Illinois and a secondB.S. degree in mechanical engineering from Rensselaer Polytechnic Institute in Troy, New York. Throughout his career,Ven has authored numerous scientific articles and abstracts. He is a 2012 recipient of the Frost & Sullivan Award fortechnological innovation in the healthcare industry.