Tuesday, June 14, 2011
7:15 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 Monitoring Medical Device Clinical Studies, A Sponsor’s Perspective: The Potential Issues and How to Avoid Them
Linda Tedder, Clinical Research Manager, Clinical Affairs, DePuy Spine, Inc.
Sponsors commit a considerable amount of time and funding to conduct a clinical study. Errors and miscalculations can result in costly mistakes, which can drive overall study costs up or delay in receiving approval/clearance. Monitoring plays a crucial role in the success or failure of a clinical study, and doing it the right way from the beginning will make a study run more smoothly. Medical device clinical studies are different than drug studies, and have some nuances that one should know before getting started. This presentation will be done from the sponsor perspective, and will cover specific medical device monitoring challenges, while briefly touching on the differences between drug and device studies. It will specifically discuss suggested tools, EDC versus paper CRF, source notes, device accountability, and AE/SAE reporting for IDE clinical studies. Additionally, it will discuss the differences in working with sponsor staff monitors and CRO monitors, and the pros and cons for both scenarios. These discussion points will be useful for any sponsor who plans to conduct any medical device study.
8:30 Study Product Management in a Widget and Gadget World
Katie McNamara, Clinical Research Associate, Medical Affairs, BD Medical, BD
Medical device trials can present complex challenges in study product accountability and reconciliation. A monitor’s interaction with study product may be different for every clinical trial in which they participate. Beyond just tracking and counting individual widgets by themselves, a monitor may be required to also count multiple gadgets in the same study, document the interaction between the widgets and gadgets, and document widget/gadget success or failure – all within a single subject. Gadgets or widgets may even be implanted into the body and are required to be tracked until removal. Each study scenario presents a unique set of monitoring challenges. This presentation will provide an overview of various study product management techniques and suggested pairings of technique and type of product. Conference attendees will gain exposure to the unique challenges associated with study product management for clinical studies involving medical devices and to potentially new techniques for management of study product.
9:00 Monitoring Medical Device and in vitro Diagnostic Studies: The Challenge and Rewards of Diversity
C. Lynn Meyers, CRA Manager, BD Medical, BD
BD, a leading global medical technology, develops, manufactures, and sells an extremely diverse product portfolio of medical devices, diagnostic products, scientific instrument systems, and reagents. As a result, clinical trial designs are heterogeneous, and monitoring requirements are highly variable. Designs can range from “small” simulated-use trials of a few dozen subjects lasting one to two days, to “medium” trials which enroll several hundred clinicians or technicians lasting several weeks, to extremely large trials of diagnostic products used for disease detection and surveillance, which may last for months or years. Each study execution scenario presents a unique set of monitoring challenges in study execution, resource, cost, and time management. Conference attendees will gain an understanding of the different trial types that are conducted for Class I to III medical devices and diagnostic products and the challenges a monitoring team encounters as they execute these trials.
9:30 Networking Coffee Break and Exhibit Viewing
9:50 Meeting the Unique Challenges of the Clinical Research Organization (CRO) Monitor
Sharon R. Sothern, BA, CCRP, Clinical Research Associate, Clinical Trials Area, Westat
This session will offer a brief background on the advantages for using CRO monitors, describe the different types of clients who use CRO CRAs, and identify several CRO monitor challenges. Each challenge identified will include a solution for addressing the challenge and real-life examples. Specific challenges to be addressed include: managing multiple projects, monitoring various therapeutic areas, time management, and limited client interaction. In addition, the CRO monitor faces unique challenges when serving as liaison between the investigator and the sponsor to manage investigator issues, managing varied sponsor expectations for addressing site corrective actions, implementing varied mechanisms for travel reimbursement, understanding data management requirements when sponsors use different data management contractors and systems, and managing expectations for addressing serious monitoring findings during a site visit. Finally, your speaker will present specific tips for becoming a great CRO CRA.
10:35 Establishing a Robust Monitoring System for Investigator-Initiated Intervention Trials
Shari Zeldin, BS, CCRC, Clinical Research Compliance Manager, University of Wisconsin Carbone Cancer Center
This session will focus on setting up a robust monitoring system for Investigator-Initiated intervention trials. Your speaker will address both monitoring to ensure protocol adherence and data quality, as well as auditing that encompasses all aspects of clinical research conduction. Topics will include proper consenting, assuring eligibility, protocol adherence, regulatory adherence, and drug accountability. Your speaker will also describe her experience utilizing a Clinical Trials management System (CTMS) as a tool for monitoring IIT data and reporting on IIT status to a data and safety monitoring committee. Specifically, attendees will be given techniques for:
Developing a robust monitoring system for investigator-initiated trials
Broadening that system to encompass affiliate sites conducting your center’s investigator-initiated trials
Identifying the resources needed to develop and sustain such a system
11:20 The Challenges of Working with Research Naïve Sites and Principal Investigators: How to Ensure Success
Alice Petersen, RN, MSN, CCRA, Lead Clinical Research Associate, Duke Clinical Research Institute
This session will describe the challenges of working with research naïve sites and principal investigators and strategies that a site management team can utilize to proactively identify and support naïve research teams. Topics will include identifying knowledge and training gaps, providing necessary training on any budget, ensuring site compliance with GCP and all applicable regulations, guidelines, and SOPs, and useful resources for new investigators. Your speaker will describe her experiences with working with a number of research naïve sites and share lessons learned.
12:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:20 Improving Monitoring Efficiency with EDC
Paul Kelly, MS, CCRA, Clinical Research Associate, Infinity Pharmaceuticals, Inc.
Monitoring efficiency is a vital component to the success of a clinical trial as it impacts both budgeting and study timelines. This presentation will detail solutions that will allow monitors to make the best use of their time on site by identifying data management and visualization tools that can be used prior to and during monitoring visits. Electronic data capture (EDC) is the most valuable tool for remote monitoring as it allows monitors to review data entry and query resolution prior to scheduling and conducting a monitoring visit. EDC can be used in conjunction with clinical trial management systems, which can track subject enrollment and scheduled monitoring visits. Data from EDC can be analyzed and viewed in aggregate with specialized data analytics software, which allows monitors to prioritize work based on which subjects have the most data pending verification and which require the most query resolution. In combination, these tools are reshaping the future of site monitoring.
2:05 CRA Compliance
Committee: One Sponsor’s Approach to Ensuring Compliance
Janice Boyd,
Principal CRA, Clinical Study Operations, Abbott Vascular
The Abbott Vascular
Field-CRA Group has initiated a CRA Compliance Committee to assist in
ensuring that consistent practices among Field CRA staff are implemented
during the conduct of clinical trials. Specifically, we will review
compliance to departmental operating procedures and standards. In
addition, potential training needs for both clinical site personnel and
FCRA staff will be suggested to help improve the overall quality of
work. This initiative is an innovative, proactive approach to compliance
that few companies have in place. The audience will be introduced to a
proactive approach to compliance that is a positive experience among
peers that helps to ensure compliance at our sites, promote consistency
in our processes, and identify training opportunities for CRAs and
sites.
2:50 Networking Coffee Break and Exhibit Viewing
3:35 Seven Traits of the Great Monitor
Leslie Humphries, Sr. Manager, Clinical Monitoring, DSP Clinical Research
Ultimately, the best CRA knows that at the end of the study, all the sponsor has is the data. They make a personal commitment to deliver quality, audit-ready data to sponsors so they can bring new drugs and therapies to the market. This talk will offer 7 key pieces of advice to give CRAs the confidence, experience, and insights to ensure the highest quality data and to develop excellent relationships with their sites. Attendees will hear about the following 7 elements essential to becoming a great CRA: (1) A personal commitment to quality data; (2) A positive “can do” attitude; (3) How to develop excellent organizational skills; (4) The ability to embrace inevitable change; (5) How to stay engaged; (6) Know-how to prevent their own burnout; (7) How to develop flexible travel strategies.
4:20 Hiring, Training, and Retaining Monitors
Paula Kovars, RN, BSN, Associate Director, RCO US Site Monitoring Group, BMS
Hiring, training, and retaining monitors are three of the most challenging issues research organizations face today. This is particularly true given the increasingly important role that monitors play in the success of the clinical trial process. This presentation will outline the important elements of Bristol-Myers Squibb’s efforts in building one of the most competitive and professionally competent monitoring groups in the industry.
Effective recruitment and interviewing techniques
Developing a focused training program
Engagement and retention strategies
Recognition and motivation
Performance feedback
5:05 Close of Conference
For Questions About the Meeting, Please Contact:
Rachel Meyers, Associate Director, Barnett International
a division of Cambridge Healthtech Institute
Email: rmeyers@barnettinternational.com
Phone: (413) 527-3056