TY - JOUR
T1 - Pragmatic study designs for older adults with cancer
T2 - Report from the U13 conference
AU - Nipp, Ryan D.
AU - Yao, Nengliang (Aaron)
AU - Lowenstein, Lisa M.
AU - Buckner, Jan C.
AU - Parker, Ira R.
AU - Gajra, Ajeet
AU - Morrison, Vicki A.
AU - Dale, William
AU - Ballman, Karla V.
N1 - Publisher Copyright:
© 2016 Elsevier Ltd
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Cancer is a disease occurring disproportionately in older adults. However, the evidence base regarding how best to care for these patients remains limited due to their underrepresentation in cancer clinical trials. Pragmatic clinical trials represent a promising approach for enhancing the evidence base in geriatric oncology by allowing investigators to enroll older, frailer patients onto cancer clinical trials. These trials are more accessible, less resource intensive, and place minimal additional burden on participating patients. Additionally, these trials can be designed to measure endpoints directly relevant to older adults, such as quality of life, functional independence and treatment tolerability which are often not addressed in standard clinical trials. Therefore, pragmatic clinical trials allow researchers to include patients for whom the treatment will ultimately be applied and to utilize meaningful endpoints. Examples of pragmatic studies include both large, simple trials and cluster randomized trials. These study designs allow investigators to conduct clinical trials within the context of everyday practice. Further, researchers can devise these studies to place minimal burden on the patient, the treating clinicians and the participating institutions. In order to be successful, pragmatic trials must efficiently utilize the electronic medical record for data capture while also maximizing patient recruitment, enrollment and retention. Additionally, by strategically utilizing pragmatic clinical trials to test therapies and interventions that have previously shown efficacy in younger, fitter patients, these trials represent a potential mechanism to improve the evidence base in geriatric oncology and enhance care for older adults with cancer.
AB - Cancer is a disease occurring disproportionately in older adults. However, the evidence base regarding how best to care for these patients remains limited due to their underrepresentation in cancer clinical trials. Pragmatic clinical trials represent a promising approach for enhancing the evidence base in geriatric oncology by allowing investigators to enroll older, frailer patients onto cancer clinical trials. These trials are more accessible, less resource intensive, and place minimal additional burden on participating patients. Additionally, these trials can be designed to measure endpoints directly relevant to older adults, such as quality of life, functional independence and treatment tolerability which are often not addressed in standard clinical trials. Therefore, pragmatic clinical trials allow researchers to include patients for whom the treatment will ultimately be applied and to utilize meaningful endpoints. Examples of pragmatic studies include both large, simple trials and cluster randomized trials. These study designs allow investigators to conduct clinical trials within the context of everyday practice. Further, researchers can devise these studies to place minimal burden on the patient, the treating clinicians and the participating institutions. In order to be successful, pragmatic trials must efficiently utilize the electronic medical record for data capture while also maximizing patient recruitment, enrollment and retention. Additionally, by strategically utilizing pragmatic clinical trials to test therapies and interventions that have previously shown efficacy in younger, fitter patients, these trials represent a potential mechanism to improve the evidence base in geriatric oncology and enhance care for older adults with cancer.
KW - Aging
KW - Cancer
KW - Clinical Trial
KW - Frail Older Adults
KW - Geriatrics
KW - Pragmatic Clinical Trials
KW - Quality of Life
UR - http://www.scopus.com/inward/record.url?scp=84971300800&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84971300800&partnerID=8YFLogxK
U2 - 10.1016/j.jgo.2016.02.005
DO - 10.1016/j.jgo.2016.02.005
M3 - Review article
C2 - 27197914
AN - SCOPUS:84971300800
SN - 1879-4068
VL - 7
SP - 234
EP - 241
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
IS - 4
ER -