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Latin America vs. Other Emerging and Non-Emerging Markets in Clinical Research: Regulations, Investigators, and Ethics Committees
Clinical Patient Recuitment: Planning Strategies and Programs
How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing
Ensuring Pivotal Study Endpoint Data QualityClinical Assistance Programs Case Study
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CHI’s Second Annual Electronic Data in Clinical Trials: Collecting and Leveraging Data to Optimize Clinical Trials will be held March 8-9, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia, PA. This year this gathering will be co-located with the Summit for Clinical Ops Executives (SCOPE), a four-day cluster of events taking place March 8-11, 2010. CHI’s Electronic Data in Clinical Trials will open with an inclusive short course on ‘Utilization of Electronic Health Record (EHR) Data in Clinical Research’ and will be followed immediately by a one-day seminar eCTD 2010 co-hosted with Bio-IT World and eCliniqua.
New technology is available and being created everyday to make the collection, correction, and assessment of data from clinical trials more efficient. The goal is to better integrate systems and data across departments and regions in order to optimize the speed and cost of trials and drug development. This conference is intended to cover the challenges related to which technologies and systems to use, measuring the ROI of technology investment, and how best to overcome the common problems with implementation.
Monday, March 8, 2010
7:30 AM Morning Coffee & Conference and Short Course Registration
8:30 Organizer’s Welcome & Chairperson’s Opening Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
Aaron Kamauu, M.D., Healthcare Data Strategy, Biometrics, Roche
MORNING SHORT COURSE:
Utilization of Electronic Health Record (EHR) Data in Clinical Research
8:40 Part 1: Connecting eHealth to Clinical Research
Susan K. Howard, Therapeutic Program Manager, Oncology Data Management, GlaxoSmithKline
Achieving effective integration between Healthcare Records and Clinical Research environments is highly desirable for many parties, yet a number of legal, technical and ethical barriers mean that today this connectivity remains largely a vision. This presentation introduces a project undertaken as a joint effort between PhRMA and the eClinical Forum which has bought together interested parties from across the worlds of eHealth and eResearch to establish an EHRCR Profile outlining suitable criteria to certify EHR systems as suitable for use in Clinical Research environment.
Learning Objectives: 1. To become familiar with EHR systems and current progress towards global adoption 2. To appreciate the benefits and challenges of the secondary application of EHR data in Clinical Research 3. To develop an understanding of the need for a profile supporting the use of EHR systems in Clinical Research and the role of EHRCR Project Team in meeting this need 4. To review ‘real world’ lessons learned from connecting electronic Healthcare and Research systems
Sponsored by9:10 Part 2: Registry-Centric Systems: The Key to Pattern Recognition in Clinical Research Gary D. Kennedy, Founder & Chief Executive Officer, RemedyMD
• Registries not electronic medical records need to become the center of the clinical data universe
• Clinical researchers do not have the time or skills to act as data base administrators
• A harmonized view of all data from all sources is essential to recognize patterns
• A registry must be sufficiently flexible to accommodate new data types or new source systems i.e. EMR
• Bloomberg got it right; data, applications and tools are all necessary to maximize productivity in highly skilled knowledge workers
9:40 Part 3: Experiences Leveraging Electronic Health Records (EHR) in Direct Support of Drug Development
Jane Myles, Global Patient and Site Recruitment Specialist, Genentech
Within Roche Pharma Development and Genentech, we are conducting 3 pilot projects focused on leveraging Electronic Health Records (EHR) in direct support of specific drug development programs/clinical trials: (1) Concept Development (mining clinical data to better understand targeted patient populations), (2) Protocol Design (using current real-world clinical data to determine the impact of specific criteria on the feasibility of a protocol), and (3) Patient Identification (having study sites identify potentially eligible patients directly from their EHR for proactive patient recruitment). Herein we present our experiences in conducting these 3 pilot projects.
10:15 End of Short Course, Networking Coffee Break
10:50 Chairperson’s Opening Remarks
11:00 Innovative Integration of Mobile and Web-based Technologies to Enable a New Model for Clinical Research – Patient-Centered Clinical Trials
Craig Lipset, Director, Global Clinical Technology, Pfizer, Inc.
The sustainable development of new medicines is challenged by clinical trial cost and complexity. The central node for trials is the brick-and-mortar investigator site, which limits the available pool of participants to those within geographic proximity. Trials are increasingly burdensome to participating patients, further contributing to delays secondary to patient recruitment. An innovative integration of mobile and internet-based technologies, along with principles of telemedicine and tools of health information technology, brings the potential for a disruptive new model, a patient-centered clinical trial. Such a model enables the patient to participate in a trial entirely from their home, removes barriers to access while opening trials to patients from traditionally underserved populations, simplifies recruitment by expanding geographic reach, and simplifies clinical trial participation. An ongoing pilot is identifying solutions to meet regulatory obligations and ensure the safety and protection of participating patients, while collecting quality data on the efficacy and safety of an investigational medicine.
11:30 Connectivity: A Critical Component for eClinical Success
Ingrid Akerblom, Executive Director, Development IT, Merck & Co., Inc.
Connecting Merck to clinical sites to drive scientific engagement as well as site productivity is central to the success of the eClinical experience. Clinical portals are being used to support this goal where success relies on well-integrated information and document management systems. The presentation will discuss the progress as well as the challenges in achieving connectivity of information as well as Connectivity with our clinical sites and CRO partners.
12:00 PM Luncheon Presentation (Sponsorship Available. Contact Arnie Wolfson: 781.972.5431, email@example.com) or Lunch on Your Own
1:25 Chairperson’s Remarks
Michael Goedde, Director, Clinical Data Management, HGS (Human Genome Sciences)
1:30 Leveraging Technology to Mitigate Financial Risk when Partnering with an EDC Vendor
Rachel Shah, MPH, CCDM, Senior Clinical Data Associate, Gilead Sciences
It is increasingly challenging to select an ideal EDC vendor. Many factors have to be taken into consideration. The key factors are financial stability of the vendor, operational performance and cost efficiency. It is often difficult to achieve all three of them equally well. This presentation illustrates a strategy that has successfully maximized our return on investment by implementing a technology solution to minimize the dependency on the vendor while achieving optimal cost efficiency and high operational performance.
Sponsored by2:10 eClinical Solutions – Playing Well with Others
Anne Zielinski, Vice President, Alliances - Medidata Solutions
Today’s biopharmaceutical companies pressed to increase clinical development efficiency are increasingly using technologies in their quest. They are carefully evaluating and choosing applications to address the requirements of specific aspects of clinical trials - investigator gathered data, eDiary data, adverse event reporting, text message reminders for subjects, and more. Using clinical data standards, these systems can now share data, eliminating duplicate entry of data, minimizing data reconciliation, and taking advantage of systems’ ability to enforce data requirements. This presentation will detail of the evolution of eClinical toward this vision of integrated data from disparate systems, looking at the benefits from various users’ perspectives. It will also peer into the future of integrated systems, and the value-add they can offer sponsors.
Sponsored by2:30 Safeguarding the Security and Reliability of Electronic Clinical Trials (ECT)
Presented by Medidata and Akamai Technologies
Jeff Livingstone, Industry Marketing Consultant, Akamai Technologies
Jim Attardi, Vice President Information Technology, Medidata Solutions
Clinical trials, which are becoming increasingly global in nature, are demanding a greater number of sites. Many of the sites selected for these trials – particularly in Asia Pacific and Latin American regions – are dispersed throughout a wide geographic area. This sparseness creates an urgent need for digitally-delivered clinical applications that can be distributed securely and reliably over the public Internet. Unfortunately, public networks linking hospitals, clinics, and doctor’s offices are often not optimal for business use, suffering from large latencies and little to no real security. In this session you will learn how Akamai has helped customers like Medidata overcome these limitations to attain the highest levels of security, reliability, and speed for Global ECT systems. These enhancements that today are providing medical practitioners with a more secure and reliable ECT experience, are decreasing the risk of drug development failure worldwide.
3:00 Networking Refreshment Break and Exhibit Viewing
3:45 Information Security and EDC: Areas of Concern
Rich Rauscher, Director of Information Technology, Pennsylvania State University
The promise of technology to speed and optimize clinical trials and research is accepted. However, when collecting and utilizing data something that must not be overlooked and offers great risk (legal, regulatory, public perception) is information security. This talk offers a realistic assessment and best practices as they relate to:
BREAK-OUT DISCUSSION GROUPS
4:15 Interactive Break-Out Discussion Groups
Concurrent break-out discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal yet informative format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
TABLE 8: Differences in Approaching Data Integration for BioTech, Small/Midsize Pharma and Big Pharma
• Does the approach towards data integration have to be different for Biotech, Small/Midsize Pharma and Big Pharma? If yes, why? If no, why not?
• For which type of company may it be easier to move towards data integration?
• Can the difficulties identified be used as an additional incentive?
• Do you need data integration in smaller companies?
• What are the company specific roadblocks that we can expect towards data integration?
• Does company culture/location play a role?
• Who (function) should lead a data integration initiative?
• What are the risks/benefits of throwing external aid in form of consultants/CROs into the data integration process? (Which company could benefit most from it?)
• What other forms of aid (other than external / CROs) can be considered?
TABLE 9: Technology to Engage Patients
• What is the future for on-line patient recruitment?
• Are we fully leveraging available technology to engage patients in clinical trials – from recruitment to data capture to physiologic monitoring and beyond?
• Where are the gaps and opportunities for the future?
TABLE 10: Overcoming Challenges in Integrating Systems (EDC, IVRS, CTMS) and Clinical Operations Data
Bob Webber, President and CEO, TranSenda International, LLC
• What are the major obstacles today for integration of clinical trial systems?
• How have standards played, or not played, a role in achieving your integration goals?
• Share your experiences on what has worked well, and what has not.
• What technologies or integration techniques are on the horizon that can help?
TABLE 11: Sharing Clinical Data across the Healthcare Spectrum - Providers, Pharma and Payers
Vipul Kashyap, Director, Applied Informatics, CIGNA
• Is there value in sharing the data?
• What types of data can each stakeholder offer and how can it benefit the other?
• Is there a cost-effective technology and architecture for rapid data sharing?
TABLE 12: Integrating Safety Reporting Data Into Your EDC System
• Is your integrated SAE/EDC system home-grown or do you have a technology partner?
• Are you able to completely eliminate all redundant data collection? If not, which data will still be collected twice?
• How will the workflow and relationships between clinical, data management and safety change with the implementation of an integrated system?
• What is your experience with piloting a new integrated system? What type of study is best for the pilot?
5:30 Closing Comments and Welcome to Reception
5:45-6:45 Networking Cocktail Reception and Exhibit Viewing
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EDC Systems Brief
Beyond EDC: Resolving Data-entry Challenges faced by Electronic Data Capture Systems in Clinical Trials
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