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Sunday, February 6, 2011
PM Pre-Conference Workshop* with CenterWatch:
1:00 - 2:00 pm Workshop Registration
2:00 – 5:30 Optimize the Process of Site Selection, Study Activation and Patient Recruitment
This workshop focuses on the strategies, tools and technologies for site identification and selection, study and budget planning, and explores a variety of new initiatives that sponsors, CROs and investigative sites are implementing to improve patient recruitment and retention effectiveness. Specifically, the workshop focuses on the following critical areas:
Site Identification, Assessment and Selection: Strategies and metrics employed by Sponsors and CROs in this process
Study and Budget Planning: Positioning your site for success in the study and budget planning process
Patient Recruitment: Exploring a variety of new approaches to improve patient recruitment and retention
Workshop Leader: Joan Chambers, COO, CenterWatch
Nye Pelton, CPC (Clinical Portfolio Consultant-Enrollment), US Medical Division - Oncology, Eli Lilly
Bonnie Brescia, Founding Principal, BBK Worldwide
Michael Jay, Vice President, RxTrials
*Separate registration required
Monday, February 7, 2011
7:30 am Conference Registration and Morning Coffee
8:15 Chairperson’s Opening Remarks
Keith Howells, Vice President, Engineering, OmniComm Systems, Inc.
8:30 Electronic Data across the Healthcare Spectrum: Collaborations between Payers, Providers and Pharma
Vipul Kashyap, Director, Clinical Decision Support and Knowledge Management, CIGNA
Current work in Clinical Trials and Healthcare IT is being performed in silos without understanding the broader context and value that can be facilitated. The healthcare ecosystem of providers, payers, pharmaceutical companies and patients will be discussed. Early examples of collaborations across this ecosystem, along with their potential impact on the healthcare ecosystem in terms of cost and improving outcomes, will also be discussed. Finally, the role of electronic data around health information and new requirements related to interoperability and decision support will be covered.
9:00 ePatients and Telemedicine Meet Clinical Trials
Miguel Orri, M.D., Senior Director, Primary Care Business Unit, Pfizer, Inc.
Healthcare is witnessing the renaissance of two forces – the rise of ePatient and the increased potential of telemedicine. A highly engaged, informed, and connected patient brings unique opportunities and risks for clinical trials. This session will explore this potential in the context of an innovative clinical trial pilot.
9:30 Strategies and Systems Supporting the Adjudication Process in Clinical Events Committees
Massimo Raineri, Ph.D., Head of Systems Development, Biometry, Actelion
Clinical Events Committees (CEC) play a fundamental role in an increasing number of clinical trials. The review and assessment of clinical endpoints subject to interpretation is performed by Clinical Events Committees in order to achieve unbiased and centralized adjudication, with a homogeneous and high level of expertise that may not be available at local site. Computerized systems can play a fundamental role in helping the sponsor to manage the full process and in providing the CEC members with best available data and integrating different data sources (CRF or e-CRF, Site documents, Images, External providers) into a single interface. When data are dynamically updated, special attention must be given to handling and tracking the changes, enabling users to easily view and understand the impact of any update.
10:00 Networking Coffee Break in Exhibit Hall
10:40 Chairperson's Remarks
10:45 Case Study: Patient-Reported Outcome Measurement Information System (PROMIS) and Assessment Center
Nan Rothrock, Ph.D., Research Assistant Professor, Medical Social Sciences, Northwestern University
Sponsored by the NIH Roadmap, the Patient-Reported Outcome Measurement Information System (PROMIS) developed instruments utilizing item response theory that assess components of physical, mental, and social health for patients with a range of chronic and other conditions frequently seen in clinical trials. Individually customized Computerized Adaptive Tests (CATs) can be administered along with short forms through Assessment Center, an online research management tool that enables creation of study-specific websites for capturing participant data securely. Assessment Center enables customization of item or instruments (e.g., format, randomization, skip patterns), real-time scoring of CATs, storage of protected health information in a separate, secure database, automated accrual reports, real-time data export, graphing of individual PROMIS CAT or Profile scores, and ability to capture endorsement of online consent forms among many other features. PROMIS instruments offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement.
11:15 Beyond EDC: Accelerating the Time to Analysis and Submission for Clinical Data
Thamar Draper, Senior Director, Product Strategy, OmniComm Systems Inc.The data captured in a data management system, whether via EDC. double data entry, or external system imports (e.g. ePRO, labs etc.), will ultimately be exported, to datasets for analysis and/or submission. The primary challenges are to consolidate the data from disparate sources, and map/transform the data from a data model optimized for data entry, cleaning and monitoring to the domains required for data analysis and reporting in a timely manner.
11:45 Sponsored Presentation (Opportunity Available)
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on your Own
1:25 Chairperson’s Remarks
Osie Gaines III, Director of Business Development, Cmed Technology
1:30 Using ODM Messages to Integrate Clinical Trial Systems and Improve Data Quality
David Borbas, Director, Clinical Data Management, Jazz Pharmaceuticals, Inc.
Increasingly, clinical trials have multiple electronic data systems to capture and manage data. These systems often have overlapping information but are currently used as isolated systems. Integrating these systems is one option to streamline data sharing and decrease errors. This presentation will focus on the use of ODM messages and web services to standardize and control data between an IVRS and EDC system currently in use at Jazz Pharmaceuticals. It will include the design, testing, and the practical aspects of the current use of this interface method in a clinical study.
Sponsored by2:00 Semantic Technology and Cloud Computing Transform Clinical Trial Data Management
Steven Kludt, Senior Vice President, Cambridge Semantics, Inc.Find out what companies like Johnson & Johnson, Merck and Biogen-Idec already know about semantic technology. Steve will explain how it enables rapid integration of data from many sources across clinical trials and makes the information much more sharable in and out of the cloud. As the regulatory environment continues to evolve, adapt in days or weeks instead of months. Understand how this technology impacts both analytics and the ability of users to discover information quickly without large IT projects.
2:30 Sponsored Presentation (Opportunity Available)
2:45 Afternoon Refreshment Break in Exhibit Hall
3:15 Using Web-Based Technologies to Integrate Patient-Reported Symptoms for Adverse Event Monitoring in Cancer Clinical Trials
Kathleen Castro, Nurse Consultant, Division of Cancer Control and Prevention, Outcomes Research Branch, National Cancer Institute
In National Cancer Institute (NCI) sponsored clinical trials, adverse events are documented using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicities and adverse events are interpreted and recorded by health providers/research staff at clinic visits. However, multiple studies have shown that clinicians under report the severity and onset of symptoms relative to patient reporting. Hence, to improve the validity of AE reporting, a dynamic electronic system for patient-reporting is needed to collect and report cancer patient symptom burden in real time. We will describe a method for utilizing web-based technologies to collect patient-centered clinical trial data. The NCI PRO-CTCAE initiative is a multi-year project that has developed a web-based tool for clinical trial patients to report the intensity, frequency and severity of 81 adverse events in the CTCAE at any time point during clinical trial participation. This tool allows for electronic data capture of PRO’s and simultaneous transmission of information to care providers, allowing for real-time intervention and a better understanding of how patients experience symptoms while taking part on clinical trials.
3:45 Electronic Data Capture (EDC) Adoption: Changes in Processes, Procedures and Training Staff (Sponsor Staff, Site, CROs)
Martin Stricker, Head Data Management, Data Management, bioskin GmbH
Electronic CRFs require different processes than paper CRFs to gain the full benefit of EDC (higher efficiency, lower cost and time); the chosen EDC system also has impact on the processes. This presentation will give experience-based recommendations on how to analyze and adapt your processes. The CRO perspective will show how to harmonize processes for several EDC systems and paper trials used in parallel by the same group. The full set of processes will also contain training strategies for the different user groups.
4:15 Sponsored Presentation (Opportunity Available)
4:30 Informal Breakout Discussion Groups
Concurrent breakout 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.
TOPIC 9: Emerging Technologies to Improve Clinical Trials
Moderator: Miguel Orri, M.D., Senior Director, Primary Care Business Unit, Pfizer, Inc.
- What emerging technologies may impact the conduct of clinical trials?
- What gaps continue to exist?
- What is a wish list vs. a realistic route forward?
TOPIC 10: The "iPad Effect" on Clinical Research
Moderator: Michael Fahy, Senior Director, Clinical Ink
- Remote Monitoring & Source Data Verification of electronic records
- Protocol compliance and investigator fraud prevention
- Impact of FDA guidance on implementation efforts
TOPIC 11: Site Responsibility for Electronic Data
Moderator: Darlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.
- How do the sites learn to set up electronic data capture tools (EHR, EDC) to meet regulatory standards?
- Do sites realize the meaning of their electronic signature within an EDC tool and the need for timeliness?
- What affect will the meaningful use, EMEA Reflection paper and FDA Part 11 inspections have for the sites/sponsors?
TOPIC 12: Electronic Health Records and Clinical Research
Moderator: Harry J. Fisher, President, Health ResearchTx LLC
- Are Phase 4 trials obsolete with secondary data use of EHRs?
- Comparative effectiveness strategies with NIH & AHRQ via EHRs
- Patient registries that are “always on”
TOPIC 13: Using CDISC: Application Integration and Data Sharing
Moderator: Keith Howells, Vice President, Engineering, OmniComm Systems, Inc.
- An appreciation of how widely the CDISC ODM capability is used in the industry
- An appreciation of how frequently such integrations need to use "vendor extensions" to transmit additional information not covered in the ODM specification
- An appreciation of whether such interfaces are typically done in batch, or real-time using web services
- An understanding of the state of progress in adopting SDTM, and what tools are used to perform the transformations needed to produce SDTM-formatted outputs
- An awareness of the adoption-rate for other CDISC offerings, such as CDASH forms
TOPIC 14: What Pain Points Are You Experiencing With EDC Systems?
Moderators: Wes Childs, Global Head, Operations, Cmed Technology
Osie Gaines III, Director of Business Development, Cmed Technology
- ClinPage, Bio-IT World and LinkedIn discussion groups are highlighting issues that sites are experiencing with today’s EDC systems
- Some problems include: EDC is too slow and not reliable, lack of access to necessary data, deciding between fast or accurate data, servers crashing during critical times and relying only on high-speed Internet connections
- What issues are you dealing with your EDC system?
- What’s your wish list for a perfect EDC system?
TOPIC 15: EMRs, EDC, & Electronic Source - What's Really Real
Moderator: Edward S. Seguine, President, Clinical Ink
- Separate "myth" from "reality" regarding EMRs and EDC as electronic source
- Identify operational impacts of implementing electronic source
- How & When will the iPad and tablet PCs affect clinical research
- Discuss receptivity of sites, monitors, sponsors to electronic source
5:30 - 6:30 Networking Cocktail Reception