Case-linked analysis of clinical trial enrollment among adolescents and young adults at a National Cancer Institute-Designated comprehensive cancer center

PURPOSE: The time it takes a performing site to activate a clinical trial can directly affect the ability to provide innovative and state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute–designated comprehensive cancer center. METHODS: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial. We applied classical quality improvement and Six Sigma methodology to determine bottlenecks and non–value-added time in activating a clinical trial. During this process, attention was paid to time to pass through each step, and perceived barriers and bottlenecks were identified through group discussions. RESULTS: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: allow parallel scientific committee and institutional review board (IRB) review and allow the clinical research coordination committee, a group that determines university interest and feasibility, to review protocols independent of the IRB and scientific committee approval. The clinical research coordination committee continues to track the activation time, and this framework is used to identify additional improvement steps. CONCLUSION: By applying quality improvement methodologies and Six Sigma principles, we were able to identify redundancies in the process to activate a clinical trial. This allowed us to redesign the process of activating a clinical trial at a matrix comprehensive cancer center. More importantly, the process map provides a framework to maintain these gains and implement additional changes and serves as an example to deploy across the campus and at other similar institutions.

Download Full-text

Communication Regarding Therapeutic Clinical Trial Enrollment Between Oncologists and Adolescents and Young Adults with Cancer

Journal of Adolescent and Young Adult Oncology ◽

10.1089/jayao.2019.0107 ◽

2020 ◽

Vol 9 (5) ◽

pp. 608-612

Author(s):

Asisa Isack ◽

Victor M. Santana ◽

Carolyn Russo ◽

James L. Klosky ◽

Karen Fasciano ◽

...

Keyword(s):

Clinical Trial ◽

Young Adults ◽

Adolescents And Young Adults ◽

Clinical Trial Enrollment

Download Full-text

2437 A prospective study of cancer clinical trial availability and enrollment among adolescents/young adults treated at a Children’s Hospital or Affiliated Adult Cancer Specialty Hospital

Journal of Clinical and Translational Science ◽

10.1017/cts.2018.154 ◽

2018 ◽

Vol 2 (S1) ◽

pp. 37-37

Author(s):

Stefanie M. Thomas ◽

Jemily Malvar ◽

Henry Tran ◽

Jared Shows ◽

David R. Freyer

Keyword(s):

Clinical Trial ◽

Young Adults ◽

Cancer Clinical Trial ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Children's Hospital ◽

Treatment Site ◽

Cancer Hospital ◽

Children’S Hospital ◽

Adult Hospital

OBJECTIVES/SPECIFIC AIMS: Low cancer clinical trial (CCTs) enrollment may contribute to the poor survival improvement for adolescents and young adults (AYAs, aged 15–39 years) with cancer. Treatment site is thought to exacerbate this problem. This study evaluated whether differences in CCT availability explain lower CCT enrollment depending on treatment site for AYAs. METHODS/STUDY POPULATION: This prospective, observational cohort study was conducted at an academic children’s hospital and an adult cancer hospital, 2 affiliated sites within a NCI-designated Comprehensive Cancer Center over 13 months. In consecutive AYA patients newly diagnosed with cancer at both site, it was determined whether an appropriate CCT existed nationally, was available locally, and if enrollment occurred. The proportions of AYAs in these categories were compared by site using the χ2 test. RESULTS/ANTICIPATED RESULTS: Among 152 consecutive AYA patients, 68 and 84 were treated at the children’s hospital and adult cancer hospital, respectively. AYAs treated at the children’s hospital had similar CCT existence nationally compared with AYAs treated at the adult hospital [36/68 (52.9%) vs. 45/84 (53.6%), p=0.938]. However, a significantly higher percentage of children’s hospital treated AYAs than adult hospital treated AYAs had an available CCT [30/68 (44.1%) vs. 14/84 (16.7%), p<0.001]. Enrollment percentages were similarly low in both groups [8/68 (11.8%) vs. 6/84 (7.1%), p=0.327]. DISCUSSION/SIGNIFICANCE OF IMPACT: Significantly fewer AYAs treated at the adult hospital had a CCT available, but national existence was similar at both sites. This suggests that institutional barriers to opening CCT have more importance at adult centers.

Download Full-text