P61 Closeout issues in a permanently implantable investigational device study
1
108s Abstracts P61 CLOSEOUT ISSUES IN A PERMANENTLY IMPLANTABLE INVESTIGATIONAL DEVICE STUDY Nancy Morgan, Jolene Overfelt, Philip Day and Anita Hurder VA Medical Center Albuquerque, New Mexico Certain issues arose during the closeout of the Department of Veterans Affairs Cooperative Study #344A, the Implantable Insulin Pump Study. One of the treatment arms to which patients were randomized involved an implantable medical device with an expected battery life span that exceeded the study duration. Implantable infusion pumps are considered by FDA to be “permanently implantable devices. ” Ethical, regulatory, and patient preference concerns led the study’s Executive Committee to develop a plan permitting voluntary implant retention beyond the projected study completion date. A similar situation could occur during any study utilizing implantable medical devices. Permitting retention of the implant beyond the study’s closeout involved the following considerations: regulatory (continued compliance with FDA’s IDE regulations and adverse event reporting requirements), ethical (do study patients have a right to continued treatment with the new technology?), informed consent (is a new consent form required?), personnel (ensuring that adequately trained personnel are available to maintain the device) and supply (assuring continued availability of an investigational insulin and buffer used in the pump). P62 THE ROLE OF THE REGIONAL STUDY COORDINATOR IN A MULTICENTER CLINICAL TRIAL Diane Balanoff and Carolyn Wood Marion Merrell Dow, Inc. Kansas City, Missouri The role of the regional study coordinator is gaining attention as the need to conduct clinical trials more efficiently and cost effectively becomes evident. There are significant clinical and operational advantages to utilizing this position, and they are explored through a discussion of a Phase 4 clinical trial. This multicenter trial was conducted in 4 regions with a total of 40 study sites, A coordinator was designated for each of the 4 regions, and each investigative site employed a local assistant to manage daily patient activity and documentation. The regional coordinator was responsible for study activities from pre-study to closure at alI of the sites within the region -- selecting investigators, training site personnel, developing recruitment strategies, assuring consistency in data across all study sites, and managing study closure. In addition to serving as liaison between study sites and sponsor, the regional coordinator functioned as sponsor advocate, resolving conflicts and issues and extending the presence of the sponsor at the site. Therefore, the requirements of regional coordinator include excellent organization and communication skills, and an understanding of the obligations of the sponsor. The benefits of utilizing a regional coordinator had a positive impact on the continuity and quality of the study and deserve consideration when designing multicenter trials.
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Transcript of P61 Closeout issues in a permanently implantable investigational device study
108s Abstracts
P61 CLOSEOUT ISSUES IN A PERMANENTLY
IMPLANTABLE INVESTIGATIONAL DEVICE STUDY
Nancy Morgan, Jolene Overfelt, Philip Day and Anita Hurder
VA Medical Center
Albuquerque, New Mexico
Certain issues arose during the closeout of the Department of Veterans Affairs Cooperative Study #344A, the Implantable Insulin Pump Study. One of the treatment arms to which patients were randomized involved an implantable medical device with an expected battery life span that exceeded the study duration. Implantable infusion pumps are considered by FDA to be “permanently implantable devices. ” Ethical, regulatory, and patient preference concerns led the study’s Executive Committee to develop a plan permitting voluntary implant retention beyond the projected study completion date. A similar situation could occur during any study utilizing implantable medical devices. Permitting retention of the implant beyond the study’s closeout involved the following considerations: regulatory (continued compliance with FDA’s IDE regulations and adverse event reporting requirements), ethical (do study patients have a right to continued treatment with the new technology?), informed consent (is a new consent form required?), personnel (ensuring that adequately trained personnel are available to maintain the device) and supply (assuring continued availability of an investigational insulin and buffer used in the pump).
P62 THE ROLE OF THE REGIONAL STUDY COORDINATOR IN A MULTICENTER
CLINICAL TRIAL
Diane Balanoff and Carolyn Wood Marion Merrell Dow, Inc.
Kansas City, Missouri
The role of the regional study coordinator is gaining attention as the need to conduct clinical trials more efficiently and cost effectively becomes evident. There are significant clinical and operational advantages to utilizing this position, and they are explored through a discussion of a Phase 4 clinical trial. This multicenter trial was conducted in 4 regions with a total of 40 study sites, A coordinator was designated for each of the 4 regions, and each investigative site employed a local assistant to manage daily patient activity and documentation. The regional coordinator was responsible for study activities from pre-study to closure at alI of the sites within the region -- selecting investigators, training site personnel, developing recruitment strategies, assuring consistency in data across all study sites, and managing study closure. In addition to serving as liaison between study sites and sponsor, the regional coordinator functioned as sponsor advocate, resolving conflicts and issues and extending the presence of the sponsor at the site. Therefore, the requirements of regional coordinator include excellent organization and communication skills, and an understanding of the obligations of the sponsor. The benefits of utilizing a regional coordinator had a positive impact on the continuity and quality of the study and deserve consideration when designing multicenter trials.
