Thursday, December 23, 2010
Electronic Data Capture Helps Researchers Take Control of Unwieldy Clinical Trial Information
James Netterwald, Ph.D.
Nov 1, 2010
Electronic data capture (EDC), simply put, is the process of using software to collect data during clinical trials. EDC technology is really a subset of eClinical technology, which includes clinical data management systems. It took a number of years before EDC became a staple in clinical trials, and although the technology has been embraced industry-wide, challenges still remain.
Clinical trial data is typically recorded initially on paper. Data is then transcribed at the clinical trial site into the EDC system. In its humble beginnings—in the late 1980s and early 1990s—EDC systems were stand-alone laptops where data from clinical trials would be keyed in a process known as remote data entry.
“Electronic data capture technology really did not take off until we got pretty thorough infrastructure improvements and Internet speeds. In the beginning, only big pharma companies were able to afford electronic data capture technology,” said Mark Paul, CEO at Statworks. Today, EDC technology is more affordable.
Paul was one of the presenters at “OpenClinica”, which was held recently in Bethesda, MD. At the meeting, he spoke about managing trial data. He also talked about FDA requirements, which include computer system validation, electronic signatures, monitoring, standard operating procedures, and training.
Prior to the establishment of EDC, the data-collection process for clinical trials was onerous. At a clinical trial site, the site coordinator would transcribe the source notes into a paper-based, controlled case report form document, which was then reviewed and retrieved by a clinical monitor and sent to a central place (e.g., firms like Statworks) that would enter it into a database.
One of the drawbacks of using paper is that it required a pretty extensive manual data-cleaning process. “We scrubbed data in detail, and the industry spent a huge amount of money cleaning its data. The process was time consuming, taking between six and eight weeks for a coordinator to receive feedback on data they had created,” Paul explained.
“This process existed for a long time and emerging technologies at the time such as the fax machine were used to try to speed up the process. With the advent of electronic data capture, instead of the site transcribing the data on a case report form source document, they would record it on a web-based application, which would immediately give them real-time feedback,” he added.
The OpenClinica Platform
The use of EDC technology in clinical trials changed dramatically with the development of OpenClinica software, according to Akaza Research, which sponsored the “OpenClinica” meeting. “One of the key trends in electronic data capture is the move toward more flexible, more easily consumable software, and as far as we’re concerned, that means a move toward open source,” said Benjamin Baumann, co-founder and director of business development.
“The OpenClinica technology is developed and distributed under an open-source license, which means that the product is available to anyone who wants to use it. Developers also have access to the underlying source code, which makes OpenClinica a very transparent technology.” With OpenClinica, site coordinators just need a browser with Internet access to enter their data.
“OpenClinica has been out there for at least five years, and we’ve been using it for the last four years. Over the last two years, OpenClinica has gotten a lot better and some of that improvement can be attributed to the nature of the open-source world,” Paul explained. “You have a lot of people using, suggesting, and/or modifying OpenClinica to fix various bugs in the software program.”
To collect data from Phase I and II trials, Social and Scientific Systems relies on case report forms using OpenClinica as a data repository, according to Naji Younes, Ph.D., principal scientist.
Essentially, data entry clerks, located at various locations across the country, key in the data that is received electronically through OpenClinica. “Once the case report forms become available for data entry, they are scanned in a central scanning facility, quality controlled and verified, and then the image of that case report form appears at the keyers’ location.
“What comes out of OpenClinica is data that has to be transformed into a format that can be read by statistical analysis software (SAS), the primary language that we use for data analysis.”
Modern EDC systems are typically web based, which is the feature that makes them readily available to clinical trial coordinators. “Web-based data-capture systems usually have a relational database at the back end. The fact that the captured data is stored in a relational database dictates how it is organized. At the other end, statisticians analyze data that is in SAS. The goals of SAS and the goals of a relational database are pretty different and the transformation requires some thought.” According to Dr. Younes, Social and Scientific Systems is working on merging those two different worlds.
Every clinical trial involves the collection of complex data with each trial containing different levels of complexity. “We do not have the luxury of being able to build from scratch custom pieces for every study. Every piece of software used in a pharma study has to be validated so it is to your advantage to build generic stuff that is clever enough to adapt itself to the idiosyncrasies of a trial. And that is just one of the issues when you are extracting data from OpenClinica,” Dr. Younes added.
Trends and Predictions
“In the past, there was a lot of work done with handheld diaries for patients. And for some studies, that still makes sense, but for others, leveraging existing electronic data capture tools can be a more cost-effective solution,” explained Susan Bornstein, executive vp of eClinical Solutions. The company has developed its own clinical data repository offering, which is designed to enable clinical trial sponsors to keep all data from a trial housed together utilizing the industry standard—Clinical Data Interchange Standards Consortium (CDISC) guidelines.
According to Bornstein, the repository “makes a difference because companies are moving out of the paper world into an electronic world where data is available in almost real time, allowing for proactive data management.”
eClinical Solutions partners with companies to help them standardize their data to meet CDISC guidelines and also comply with Title 21 CFR Part 11, which governs how electronic systems can be used in clinical trials.
In order to meet FDA guidelines for clinical trial data collection, web-based EDC technologies have to be transparent, not proprietary. “One of the key challenges that eClinical technologies should try to address is bringing greater transparency and efficiency across the clinical trial process, for example, by enhancing connectivity and removing silos among the various clinical constituencies,” noted Ashwin Mundra, director of strategic initiatives for Medidata Solutions.
According to Mundra, clinical constituencies include not just the clinical department but also finance, data management, trial management, and trial sites. “One of the main goals of pharma is to remove these silos to help enhance and streamline clinical processes and solve problems that are common to all these departments, not just data management.”
Baumann agreed that transparency in EDC systems is essential. “The way I see this technology moving in the next five years is toward a lighter-weight approach. I really think that open source is one of the primary drivers of the trend. What electronic data capture systems provide today is really centered on the quality of data, the speed at which data can be collected, and the transparency that the system provides the progress of the clinical trial.”
With the pressure on for earlier, faster clinical trial results, clinical data management systems (CDMS) must keep up, with quick deployment, incisive data analytics and increased automation.
The costs of clinical trials keep rising, and budget and market pressures mean that sponsoring organizations want fewer trials, with as much research packed in as possible and faster data analysis and results. Patient, ethical and regulatory demands keep increasing, with clinical trials sometimes extending post-marketing. There’s marked growth potential for clinical trials, and users are looking for feature-rich, flexible technologies to manage the entire process. Organizations also want results earlier in a clinical trial than ever before, and maturing technology can help get those results and make immediate changes in response.
Electronic data capture (EDC) technology supports more complex trials, and collects data from a wide range of sources. Technologies around clinical data management are moving toward a more holistic approach, with integration of CDMS and EDC systems, and the availability of software suites around clinical trial management. CDM systems are adding automation around protocol design, and working to eliminate user errors and redundancies throughout the entire trial process. Hosted and on-demand options are available, as are outsourced options with contract research organizations (CROs).
Best-in-Class Clinical Data Management Systems Features:
- Ability to link and share records with other systems, and facilitate integration or interoperability across data sources
- Supports global outsourcing with constant tech support and business continuity plans for clinical trials
- Analyzes data and performance metrics in real time to allow for speedy decision-making and trial adjustments
Top Considerations Before Buying Clinical Data Management Systems:
An effective clinical data management system should be highly available and scalable. As the clinical trial market becomes more competitive and demanding, software should keep up, with capabilities like interactive voice and web response, intelligent protocol design and real-time progress tracking. A fully integrated clinical infrastructure is the next step, offering a holistic view across trials and data sources, and minimizing redundancy and the possibility of error. CDM systems should support new developments in trial design, meant to identify failures at an earlier clinical trial stage. Users should be able to access productivity and performance metrics quickly and easily. Technology adoption will continue as clinical trial management becomes more complex and more important.
1. BioClinica delivers electronic data capture, medical imaging management and data management solutions for clinical development life cycle. The BioClinica Data Management service is run by clinical data managers to help capture clean, accurate trial data. BioClinica Express is an electronic data capture system that provides a central hub to collect and manage clinical trial data, with easy data import and export. BioClinica IVR/IWR incorporates interactive voice response and interactive web response information into clinical trial data.
2. Phase Forward provides integrated data collection and data management solutions for clinical trials and drug safety. Phase Forward’s Clintrial is a clinical data management system that collects, manages and reviews clinical data. InForm GTM, an electronic data capture (EDC) system, is a set of reporting and analysis tools let sponsors view and act on data as soon as possible in the trial development. Phase Forward’s WebSDM tool lets users test FDA submissions for compliance and integrate clinical datasets from various sources.
3. eClinical Solutions, a division of Eliassen Group, provides a team of clinical data management, training and consulting experts who facilitate and expedite electronic management of data in clinical trials for pharmaceutical, biotechnology and medical device companies. eClinical Solutions provides data management services, EDC
services, Statistical programming, training and reporting solutions, user acceptance testing (UAT)/validation services, as well as clinical data repository solutions. Their service offerings include functional outsourcing, staff augmentation or project solutions.
4. StudyManager provides clinical trial management software (CTMS) and EDC solutions to organizations that sponsor or conduct clinical trial research. StudyManager brings all critical trial data into the same system, and offers site progress tracking, productivity and tracking reporting, payment tracking, enrollment data monitoring and direct database access. Their Sponsor Edition (SE) software, designed for rapid deployment, is ideal for smaller or early phase trials, and for trials with budget constraints. Tools are available on demand and backed by consulting and other support services.
5. Medidata is a global provider of hosted clinical development solutions that streamline the design, planning and management of key aspects of the clinical development process, including protocol design and development, investigator benchmarking and budgeting, contract research organization benchmarking and budgeting and the capture, management, analysis and reporting of clinical trial data. Medidata Designer automates protocol design, using previous studies and company standards, and reduces the possibility of manual errors during clinical studies.Clinical Data Management Systems
Definition: Clinical data management systems are used in clinical research to manage the data of a clinical trial. Also referred to as CDMS, clinical data management systems store the clinical trial data gathered at the investigator site in the case report form. CDMS reduce the possibility of human error by using different means to verify the entry, the most common method being double data entry.
Tuesday, October 12, 2010
|Health System Decision Support Report Product Manager|| Apply Now |
Works under minimal supervision to manage the financial, operational, clinical and quality data analysis, marketing strategic planning and demonstration/training to customers.
- Plans and leads the technical design, development and programming related to analytic and clinical data-driven deliverables.
- Researches, analyzes, and calculates quality indicator measures related to clinical topics and conditions across all healthcare settings; performing integrity analysis to identify data quality and integrity issues, as well as random sampling, benchmarking and trending of data.
- Define requirements for ad-hoc analysis queries and dash boarding involving outcomes analysis, health service research activities, testing various measurement approaches to support customer reporting.
- Manages bottlenecks, provides escalation management, anticipates and makes trade-offs, balance the business needs versus technical constraints, and maximizes business benefits while building great customer experiences.
- Designs reporting templates and creation of report mock-ups and finals reports illustrating the results of the analytic and programming processes.
- Performs client needs analysis and assessment; collaborates with clients and business analysts to identify and clarify program, business and functional requirements; management of client expectations and relationships.
- Provides input and subject matter expertise into Business Intelligence solutions to minimize the frequency of ad hoc data requests and analysis.
- Provides gold standard for cross-departmental testing and parallel processing efforts; develops test case scenarios; identifies bugs and monitors and tracks through resolution.
- Researches and identifies opportunities for the institution to further distinguish itself among the healthcare community.
- Define a long term produce roadmap, including technical, business development, and marketing initiatives.
Bachelor’s degree in business, healthcare administration, or public health, eight (8) years experience with project consulting and matrixed management responsibilities in complex organizations. Master’s degree preferred.
|Decision Support Manager - Health Systems|| Apply Now |
Works under minimal supervision to provide health system decision support for senior management, design and format Health System leadership management reports, and define business rules for use and display of data to monitor health system performance.
1. Provides managerial oversight for Decision Support functions and staff.
2. Supports and coordinates institutional wide financial and clinical initiatives.
3. Serves as a resource to both Financial and Clinical leadership to support organizational decision making, clinical and financial initiatives and strategic planning activities.
4. Develops other data collection tools, analyzes data, and provides input in the making of operational decisions as required.
5. Analyzes reports and provides senior management with written and verbal reports on pertinent variances/trends, providing recommendations for process improvements.
6. Meets with managers and directors to design and develop analytical reports that assist them with their strategic or operational decision making process.
7. Identifies opportunities to improve organizational efficiency and effectiveness, including faster, easier, more efficient ways to manipulate and report data.
8. Works effectively with related department managers in the development and maintenance of reports.
Bachelor’s degree in business, healthcare administration, public health or related field and 8 (eight) years experience in decision support management. Master’s degree preferred.
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Friday, April 23, 2010
看官們請別誤會，本文不是要獨家掲露Google台灣有計劃將目前僅運用在美國的Google Health搬至台灣，至少，截至今日還未聽到Google台灣有邀約台灣醫療(健康)單位參與該平台的動作；本文要討論的議題是，台灣民眾有沒有可能跟 美國民眾一樣，有個免費的開放性醫療管理平台紀錄個人健康資訊。
Google Health係一個能讓民眾將自己的電子病歷等醫療紀錄放置於其上的開放性醫療管理平台； 而且，透過與醫療業者合作的方式，Google Health亦有提供各式健康管理服務，如健康紀錄(Profile detail)、重要的用藥紀錄(Import medical records)、瀏覽健康服務(Explore health services)、分享個人檔案(Share this profile)與線上搜尋醫生資訊(Medical contacts-find a doctor)等。
Google Health的出現不僅有助於實現Health 2.0(由民眾自行管理自己的健康資訊)，亦有助於活絡健康照護產業。對使用者來說，Google Health等同是個人的健康小管家，因為該平台可提醒使用者用藥時間以及視使用者需求提供醫療相關資訊等；對使用者的親朋好友來說，Google Health則是一個助其了解使用者健康狀況的好幫手，當然，前提是使用者願將其放置在Google Health上的健康資料分享給親朋好友；對醫療業者來說，Google Health的出現，除有助於其曝光，亦可避免其陷入醫療人手不足的窘境。
Google Health不易在台推行。Google Health雖好，但我認為短期內Google台灣不大可能將Google Health服務搬到台灣來，理由很簡單：尚未中文化、不是每個人(如老年人等)都有能力使用這些免費的「線上」健康管理服務，以及Google台灣上哪 去找願意與其合作的醫療(或健康)單位等。事實上，就算前面三個問題都解決了，也還有法規(醫療法與醫師法等)問題存在，如醫療法規定病歷等資訊只有病患的直屬醫生與照護人員可 看。
「無論使用者是使用哪種終端感測裝備，以及至哪家醫療院所就診，都可將上述醫療資訊匯至嶺東科大的醫療管理平台上。」嶺東科技大學資訊 網路系系主任陳志明表示，鑒於台灣健康照護產業欠缺一套開放性的醫療管理平台，嶺東科技大學遂以強調開放性的IBM Maximo為核心，以及自行研發出的居家閘道器(OSGi)等技術為輔，建置出一套可用來監測、紀錄、維護(健康檢查)、保養(看診)、追蹤與警示使用 者(受照護者)的生(心)理狀況的開放性醫療管理平台。
嶺東科大是以所有民眾為目標市場。「除了老年人口需要醫療管理平台進行健康照護，小孩子等也有此需 求」他指出，雖然嶺東科大以健康4U計畫申請教育部補助時，是以銀髮族為該平台的首要服務對象，但鑒於每個人都需要一套醫療管理平台，遂計畫於其後將平台 開放出去，讓每位台灣民眾都可以透過該平台管理自己的健康狀況。
在「鴻海進軍健康照護產業 會產生什麼漣漪？」一文中，我已簡單描述過台灣健康照護產業的一些狀況，諸如台灣的健康照護產 業因日趨小型化(私人化/區域化)導致健康照護服務無法互通、非所有醫療單位都有能力提供所謂的健康照護管理服務、欠缺具體可明的獲利模式，以及現行的醫 師法與醫療法的部分規定有礙健康管理產業發展等，而且，就連鴻海集團的加入，也無助於解決上述所有問題，更何況是嶺東科大？
「開放平台有助於建構完整的產業生態鏈，至少有拋磚引玉的功效，」陳志明指出，台灣的健康照護服務產業之所以沒有任何堪稱具體的商業營 運模式，與醫療單位提供的健康照護服務多走向小型化、區域化有關。他解釋，小型化、區域化除意味著使用者無法將現在使用的A家健康照護服務攜至B家去外，對提供終端感測儀器與心理諮詢輔導等醫療相關服 務的業者來說，小型化意味著使用人數不多，使用人數不多則意味著業者可從中獲利的比例有限，在這樣的狀況下，為取得政府科專補助的醫療業者多半是抱持觀望 的心態，在看健康照護市場。
嶺東科大將師法Google Health解決商業模式不明等窘境。第一步是以城鄉包圍鄉鎮的方式解決一線醫療院所不願釋出民眾就診資料等問題：透過與二線醫療院所 合作的方式，如大甲李綜合醫院與埔里基督教醫院附設愚人之友基金會等，讓民眾適應與接受健康照護服務，累積一定的使用人數後，即可向一線醫療院所商討釋出 民眾就診資料一事。
陳志明指出，在解決民眾無法取得健康資料這個問題後，嶺東科大打算透過整合醫療管理平台與電子商務平台的方式，賺取虛 擬醫療商城營運費用與廣告刊登費用，「嶺東科大打算師法Google Ads機制，推出使用者點擊後方計價的廣告收費模式。」他說。
僅有嶺東科大拋磚引玉還不夠。首先，嶺東科大雖建置出開放性醫療管理平台，並試著提出一套看來頗具 體的商業(獲利)模式，但未必有助於活絡台灣健康照護產業；理由是，法規依舊侷限了健康照護產業發展，再加上，嶺東科大雖有意將研發出的醫療管理平台開放 出去，但仍處於「想」這麼做而非「已經」這麼做的階段。
台灣的健康照護市場尚未起飛。近幾年來，伴隨老年人口逐漸增加，以及台灣政府的加持，確實有不少業 者(醫療院所與相關的軟硬體業者)競相投入該塊市場，只不過，礙於服務不可攜(與醫療院所的本位主義有關)、銀髮族不大會操作ICT產品、醫療法與醫師法 等法規限制，以及使用者仍對健康照護服務的資訊安全有所疑慮等，真正買單的使用者數目仍不多，使用者不多，商機自然有限。
鴻海集團與嶺東科大的加入有可能改善使用人數不多這個最根本的問題。由於鴻海集團本身的使用者(員 工)就夠多，因此，即便鴻海集團與訊聯合資成立的康聯生醫科技最後沒將健檢中心開放給一般民眾使用，光就鴻海集團這個使用單位，即有一定的經濟規模；至於 嶺東科大，雖然其尚未全面對外開放其研發的開放性醫療管理平台，以及招募到許多願意至該平台上開設虛擬醫療院所(商城)的業者，但其的出現，確實是有助於 活化台灣的健康照護產業─至少目標市場已從原先著重的銀髮族擴展到全民。
透過策略聯盟活化健康照護產業生態─提供整合式醫療服務。由於健康照護產業所涉及的服務種類極多且 廣，絕非單一醫療業者可以提供，因此，業者能否放開心胸，尤其是一線醫療院所，透過策略聯盟提供整合式醫療服務，亦將左右市場規模；畢竟，當醫療服務可與 保險、保全、娛樂、教育、金融等服務進行搭配銷售時，比較有機會吸引使用者買單、甚至是提升醫療服務的使用率。
事實上，台灣的醫療業者多已明瞭策略聯盟的重要性，如三軍總醫院、惠普和年代數位媒體於去(08)年底發表的「M-Taiwan應用推廣計畫」階段成果：「M-Life全視界生活網」及 「M-Care全民行動照護網」等，只不過，老話一句，因為服務不互通，所以，買單的使用者有限，但該問題或許在開放性醫療平台問世後，即可解 決。