NURSES AS INSTRUMENTS FOR CHANGE: INCORPORATING THE ELDERLY IN CLINICAL TRIALS SAFETY

2.50
Hdl Handle:
http://hdl.handle.net/10755/165248
Category:
Abstract
Type:
Presentation
Title:
NURSES AS INSTRUMENTS FOR CHANGE: INCORPORATING THE ELDERLY IN CLINICAL TRIALS SAFETY
Author(s):
Gerber, Donna
Author Details:
Donna Gerber, PhD RN AOCN, Advanced Practice Nurse, M. D. Anderson Cancer Center, Houston, Texas, USA, email: dgerber@mdanderson.org
Abstract:
The elderly (those 75 and older) suffer a great burden from cancer. The baby-boomer generation has enjoyed many new developments in medical science and their expectations will continue to increase and become more apparent as their need for medical intervention increases. It is known that as a person ages the bodyÆs systems do not function as efficiently. New targeted-therapies and combination therapies are being investigated daily in clinical trials. A concern identified by nurses was that often there was an age limit for older adults or they were excluded secondary to co-morbidities from many Phase I/II trials. Only when approved by the FDA do these new drugs or combinations become available to the elderly. When oncologists prescribe these new treatments, they have little data on how the elderly will metabolize and tolerate these treatments with their decreasing bodily functions. Nurses identified this as a safety concern for future patients once FDA approval occurred. Also, research nurses were frustrated in excluding the elderly with good performance status from clinical trials. Within our institution some nurses started asking the principle investigators (PIs) for an override to include older patients. Also, nurse reviewers for new protocols started to question upper age limits and this issue required a satisfactory response by the PI before the protocol preceded to the Institutional Review Board (IRB). The IRB members started to notice these comments in the reviews and also started questioning age limits. Slowly over time changes have been seen in new clinical trials. The most dramatic change seen in new clinical trials presented to the IRB over the last year is that most do not have an upper age limit. Also, elderly or patients above 75 years of age are done in a separate cohort (group) in some Phase I/II trials using the same dose but only after at least 3 patients under 75 have safely completed that dosing cohort. As pharmokinetics and/or pharmodynamics are usually involved this is beneficial enabling comparison of toxicities between populations. This demonstrates that nursing can be an instrument for a change in philosophy and safely incorporate elderly in clinical trials.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2007
Conference Name:
32nd Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Las Vegas, Nevada, USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleNURSES AS INSTRUMENTS FOR CHANGE: INCORPORATING THE ELDERLY IN CLINICAL TRIALS SAFETYen_GB
dc.contributor.authorGerber, Donnaen_US
dc.author.detailsDonna Gerber, PhD RN AOCN, Advanced Practice Nurse, M. D. Anderson Cancer Center, Houston, Texas, USA, email: dgerber@mdanderson.orgen_US
dc.identifier.urihttp://hdl.handle.net/10755/165248-
dc.description.abstractThe elderly (those 75 and older) suffer a great burden from cancer. The baby-boomer generation has enjoyed many new developments in medical science and their expectations will continue to increase and become more apparent as their need for medical intervention increases. It is known that as a person ages the bodyÆs systems do not function as efficiently. New targeted-therapies and combination therapies are being investigated daily in clinical trials. A concern identified by nurses was that often there was an age limit for older adults or they were excluded secondary to co-morbidities from many Phase I/II trials. Only when approved by the FDA do these new drugs or combinations become available to the elderly. When oncologists prescribe these new treatments, they have little data on how the elderly will metabolize and tolerate these treatments with their decreasing bodily functions. Nurses identified this as a safety concern for future patients once FDA approval occurred. Also, research nurses were frustrated in excluding the elderly with good performance status from clinical trials. Within our institution some nurses started asking the principle investigators (PIs) for an override to include older patients. Also, nurse reviewers for new protocols started to question upper age limits and this issue required a satisfactory response by the PI before the protocol preceded to the Institutional Review Board (IRB). The IRB members started to notice these comments in the reviews and also started questioning age limits. Slowly over time changes have been seen in new clinical trials. The most dramatic change seen in new clinical trials presented to the IRB over the last year is that most do not have an upper age limit. Also, elderly or patients above 75 years of age are done in a separate cohort (group) in some Phase I/II trials using the same dose but only after at least 3 patients under 75 have safely completed that dosing cohort. As pharmokinetics and/or pharmodynamics are usually involved this is beneficial enabling comparison of toxicities between populations. This demonstrates that nursing can be an instrument for a change in philosophy and safely incorporate elderly in clinical trials.en_GB
dc.date.available2011-10-27T12:15:08Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:15:08Z-
dc.conference.date2007en_US
dc.conference.name32nd Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationLas Vegas, Nevada, USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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