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.
Bibliographical noteFunding Information:
The Cancer and Aging Research Group (CARG), in collaboration with the National Institute on Aging (NIA) and the National Cancer Institute (NCI), has been holding a linked conference series funded by a U13 grant (Co-PI: Hurria, Mohile, Dale) to examine the level of evidence and areas of highest research priority in geriatric oncology. The initial conference, held in 2010, found that clinical trial infrastructure often fails to meet the needs of older cancer patients and rarely incorporates geriatric-specific data into the existing framework. 10–12 The second conference, held in 2012, provided recommendations for improving geriatric oncology research and sought to focus on how best to design and implement clinical trials for older adults with cancer. 13 From May 13 to 14, 2015, CARG/NIA/NCI held the third conference in this series. The goal of this conference was to focus on the design and implementation of intervention studies to improve or maintain the quality of survivorship in older adults with cancer. This article summarizes the section focused on methodology, with an emphasis on pragmatic clinical trials.
Ryan Nipp, Nengliang (Aaron) Yao, Lisa M. Lowenstein, Jan. C. Buckner, Ira R. Parker, Vicki A. Morrison, William Dale, and Karla V. Ballman have no conflicts of interest to disclose. Ajeet Gajra discloses advisory/consulting roles with Bayer, Celgene and Helsinn and research funding from Celgene and Merck.
This work was funded with a U13 AG038151 from the National Institute on Aging. The work was also funded by the American Cancer Society and a Patient-Centered Outcomes Research Institute (PCORI) Program contract (4634). The work received support from the James Wilmot Cancer Institute (WCI), the Alliance for Clinical Trials in Oncology (National Cancer Institute of the National Institutes of Health under the U10CA18082 and 1UG1CA189823 awards), and UG1 CA18961 from the National Cancer Institute. This work was made possible by the generous donors to the WCI geriatric oncology philanthropy fund. All statements in this report, including its findings and conclusions, are solely those of the authors, do not necessarily represent the official views of the funding agencies, and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
© 2016 Elsevier Ltd
- Clinical Trial
- Frail Older Adults
- Pragmatic Clinical Trials
- Quality of Life