Strategies for the Administration of a Clinical Trials Infrastructure: Lessons from a Comprehensive Cancer Center

2007 ◽  
pp. 241-274 ◽  
Author(s):  
Leonard A. Zwelling ◽  
Carleen A. Brunelli
Keyword(s):  
Clinical Trials ◽  
Comprehensive Cancer Center ◽  
Cancer Center

scholarly journals Definition and Coordination of Roles and Responsibilities Among Cancer Center Clinic and Research Personnel

2020 ◽  
Vol 16 (1) ◽  
pp. e64-e74
Author(s):  
Simon J. Craddock Lee ◽  
Torsten Reimer ◽  
Sandra Garcia ◽  
Erin L. Williams ◽  
Mary West ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Physician Attitudes ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Research Staff ◽  
Research Personnel ◽  
Delivery Of Care ◽  
Roles And Responsibilities ◽  
Clinic Staff ◽  
Staff Members

PURPOSE: Effective enrollment and treatment of patients in cancer clinical trials require definition and coordination of roles and responsibilities among clinic and research personnel. MATERIALS AND METHODS: We developed a survey that incorporated modified components of the Survey of Physician Attitudes Regarding the Care of Cancer Survivors. Surveys were administered to clinic nursing staff and research personnel at a National Cancer Institute–designated comprehensive cancer center. Results were analyzed using χ2-tests, t tests, and analyses of variance. RESULTS: Surveys were completed by 105 staff members (n = 50 research staff, n = 55 clinic staff; 61% response rate). Research staff were more likely to feel that they had the skills to answer questions, convey information, and provide education for patients on trials (all P < .05). Both clinic and research staff reported receipt of communication about responsibilities in fewer than 30% of cases, although research staff reported provision of such information in more than 60% of cases. Among 20 tasks related to care of patients in trials, no single preferred model of responsibility assignment was selected by the majority of clinic staff for nine tasks (45%) or by research staff for three tasks (15%). Uncertainty about which team coordinates care was reported by three times as many clinic staff as research staff ( P = .01). There was also substantial variation in the preferred model for delivery of care to patients in trials ( P < .05). CONCLUSION: Knowledge, attitudes, and perception of care and responsibilities for patients on clinical trials differ between and among clinic and research personnel. Additional research about how these findings affect efficiency and quality of care on clinical trials is needed.

Metastatic colorectal cancer (mCRC) patterns of care: Implications for clinical trial design

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4079-4079 ◽  
Author(s):  
C. S. Denlinger ◽  
M. A. Collins ◽  
Y. Wong ◽  
S. Litwin ◽  
N. J. Meropol
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Treatment Change ◽  
Therapy Regimen

4079 Background: New approaches have expanded options for patients (pts) with mCRC. To characterize current practice paradigms that might bear on clinical trial design, we analyzed decision-making and treatment patterns in pts treated at a Comprehensive Cancer Center since the introduction of cetuximab (CET), and bevacizumab (BV). Methods: A retrospective review of all pts diagnosed with mCRC between 3/1/04 and 8/28/06 treated at Fox Chase Cancer Center. Results: 160 pts were treated, with 157 pts receiving at least one therapy regimen by 10 attending oncologists. There were 350 changes in therapy with 246 (70%) including continuation of at least one prior drug (92 BV, 111 fluoropyrimidines, 43 other). The most common reasons for treatment change were toxicity (33%), progressive disease (PD) (29%), treatment breaks (15%), and metastasectomy (11%) ( Table ). PD was a more common cause for treatment discontinuation in later phases of treatment (18% initial regimen vs. 36% subsequent regimens, p=0.0002). 24% of pts treated with oxaliplatin (OX) discontinued due to neuropathy. Hypersensitivity caused discontinuation in 5% of pts with OX and 7% of pts with CET. Resection of metastases was undertaken in 38% of pts. 43% of these pts received neoadjuvant therapy, and 56% received adjuvant therapy. 30% of pts have died, 29% remain on active treatment, 28% are on a treatment break, 3% are on hospice, and 11% are lost to follow-up. Conclusions: PD is no longer the primary reason for change of therapy in pts with mCRC. Metastasectomy is common and OX neuropathy is often treatment-limiting. These findings have important implications for endpoint selection and design of clinical trials in mCRC. Future clinical trials in mCRC must recognize treatment complexities and capture key components of decision-making that may result in prolonged survival. Furthermore, treatment breaks represent a potential window for the evaluation of new drugs. [Table: see text] No significant financial relationships to disclose.

Health care worker attitudes about clinical trials at a comprehensive cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20633-e20633
Author(s):  
Erica Leigh Campagnaro ◽  
Seunghee Margevicius ◽  
Barbara J. Daly ◽  
Jennifer Rachel Eads ◽  
Tyler G. Kinzy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Small Sample Size ◽  
Educational Interventions ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Normative Beliefs ◽  
The Impact

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

scholarly journals Monitoring Twitter Conversations for Targeted Recruitment in Cancer Trials in LA County: Protocol for a Mixed-Methods Pilot Study (Preprint)

2018 ◽  
Author(s):  
Katja Reuter ◽  
Praveen Angyan ◽  
NamQuyen Le ◽  
Alicia MacLennan ◽  
Sarah Cole ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Pilot Study ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Translational Science ◽  
The Social ◽  
Media Intervention ◽  
Twitter Users

BACKGROUND Insufficient recruitment of participants remains a critical roadblock to successful clinical research, in particular clinical trials. Social media (SM) provides new ways for connecting potential participants with research opportunities. Researchers suggested that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. OBJECTIVE The objective of this pilot study is to examine the feasibility and impact of using Twitter monitoring data (i.e., user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in LA County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. METHODS We will conduct a mixed-methods interrupted time series study design with a before and after SM recruitment intervention. Based on a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across six disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the USC Norris Comprehensive Cancer Center (USC Norris). We will monitor messages about the six cancer conditions posted by Twitter users in LA County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes include, first, feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials, which will be assessed using qualitative interviews and 4-point Likert scale, and calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of people who enrolled in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. RESULTS This study has been funded by the National Center for Advancing Translational Science (NCATS) through a Clinical and Translational Science Award (CTSA) award. Study approval was obtained from the Clinical Investigations Committee (CIC) at USC Norris and the Institutional Review Board (IRB) at USC. Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. CONCLUSIONS This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants center across six cancer disease types. We will shed light on the acceptance of the SM intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite, randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations.

scholarly journals Trial Prospector: Matching Patients with Cancer Research Studies Using an Automated and Scalable Approach

2014 ◽  
Vol 13 ◽  
pp. CIN.S19454 ◽  
Author(s):  
Satya S. Sahoo ◽  
Shiqiang Tao ◽  
Andrew Parchman ◽  
Zhihui Luo ◽  
Licong Cui ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Survival Rates ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Dramatic Improvement ◽  
Multiple Sources ◽  
Eligibility Criteria ◽  
Physician Participation ◽  
Time Required

Cancer is responsible for approximately 7.6 million deaths per year worldwide. A 2012 survey in the United Kingdom found dramatic improvement in survival rates for childhood cancer because of increased participation in clinical trials. Unfortunately, overall patient participation in cancer clinical studies is low. A key logistical barrier to patient and physician participation is the time required for identification of appropriate clinical trials for individual patients. We introduce the Trial Prospector tool that supports end-to-end management of cancer clinical trial recruitment workflow with (a) structured entry of trial eligibility criteria, (b) automated extraction of patient data from multiple sources, (c) a scalable matching algorithm, and (d) interactive user interface (UI) for physicians with both matching results and a detailed explanation of causes for ineligibility of available trials. We report the results from deployment of Trial Prospector at the National Cancer Institute (NCI)-designated Case Comprehensive Cancer Center (Case CCC) with 1,367 clinical trial eligibility evaluations performed with 100% accuracy.

Comparison of the demographics of patients enrolled (E) versus those not enrolled (NE) on therapeutic clinical trials at a comprehensive cancer center

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17065-17065
Author(s):  
S. Goodin ◽  
D. C. Vamos ◽  
M. P. Kane ◽  
J. Nishioka ◽  
S. Lisi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Demographic Data ◽  
Private Insurance ◽  
Univariate Analysis ◽  
The Elderly ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Chi Square ◽  
Enrollment Rates

17065 Background: In the U.S., representation of minorities and the elderly in clinical trials has been low yet few reports have evaluated this potential barrier to enrollment by comparing the demographics of patients E vs NE within an institution. Therefore, we compared these groups to determine if there were significant differences in demographics at our center. Methods: For all E patients, demographic data is collected in a clinical trial database. For evaluated NE patients, data was captured through a ‘non-protocol’ form. A univariate analysis was performed on the demographic data, including gender, age, race, and insurance status, for each year to determine if there were differences in patients E vs NE on a therapeutic clinical trial. Results: From June 2003 through December 2005, there were 912 E patients and data available on 474 NE patients. The results were consistent for each year from 2003 to 2005, and therefore combinable, with no statistical difference in any parameter for E patients versus NE patients during any year with the exception of gender (p=0.05; Chi-square). The distribution of patients E by gender is 52% (474/912) female vs 48% (438/912) male and NE is 69% (325/474) female vs 31% (149/474) male. The mean age of E patients was 55 vs 56 years for NE patients, with 32% vs 33% representing those >65years, respectively. For the E patients, 84% were white, 7.2% black, 4.6% Asian, 4.2% unknown, and 0.4% Hawaiian/Pacific Islander (H/PI). For the NE patients, where race was not consistently available, 65% were white, 9.3% black, 3.2% Asian, 20.5% unknown, and 2.1% H/PI. In both groups, most patients had private insurance (E 60%, NE 54%), followed by Medicare (E 27.5%, NE 29%), Medicaid (E 4%, NE 9%), self pay (E 7.5%, NE 7.4%), and unknown (E 1.3%, NE 0.4%). Conclusions: When comparing E vs NE patients, gender was the only factor that differed significantly. Although this result suggests that males were more likely to be E in a clinical trial, this finding should be interpreted with caution, since this difference might relate to differences in trial availability. While lower enrollment rates for the elderly and minority patients have been identified nationally, enrolling this group of patients does not appear to be a barrier at our center. No significant financial relationships to disclose.

Radiation pneumonitis (RP) in lung cancer patients treated with chemotherapy (CT) and thoracic radiation (TR): Retrospective analyses of patients treated at a comprehensive cancer center

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19642-19642
Author(s):  
P. Vishnu ◽  
S. Srinivasan ◽  
L. Heilbrun ◽  
R. Venkataramanamoorthy ◽  
A. Wozniak ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Hospitalization Rate ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Lung Cancer Patients ◽  
Pulmonary Disorder ◽  
Demographic Features

19642 Background: Combined CT and TR is the current standard for locally advanced non-small cell lung cancer (NSCLC) and SCLC. Severe RP, an important adverse effect of TR, is reported in clinical trials to occur in 10% of patients receiving CT and TR. The rate in routine care may be higher as patients are not selected based on lung function. We conducted a retrospective study to assess the incidence of RP in lung cancer patients treated with CT and TR. Methods: Retrospective identification of patients who underwent combined modality therapy (concurrent or sequential CT and TR) for lung cancer (NSCLC & SCLC) at our cancer center between January 2001 and December 2004. Demographic features, RP incidence and grade (RTOG criteria), hospitalization rate and overall survival (OS) were assessed. Results: 51 patients who met the selection criteria were analyzed. The demographic features were - males 61%; Caucasians - 53%; African Americans - 39%; history of pulmonary disorder - 45%; NSCLC - 82%; CT - 62% received Cisplatin/Etoposide, while 24% received Carboplatin/Paclitaxel; 92% received concurrent CT and TR. The median dose of TR was 5940 cGy. 20 patients (39%) developed RP; 13 (25%) had grade = 3 RP. Median time to development of RP was 4.4 months. Rate of RP in females and males was 50% vs. 32% (p=0.25). Rate of RP in patients with pulmonary disorder at baseline was 52% vs. 29% in others (p=0.15). 1 year hospitalization rate was 75% and 42% in RP and non-RP patients (p=0.025). For all 51 patients, the median overall survival (OS) was 16.4 months (95% CI 11.8 - 23.3). Length of OS did not differ significantly (p = 0.36) between the 20 patients who had RP vs. the 31 who had no RP (median OS: 22.2 vs. 14.5 months, respectively). Conclusions: The RP rate in these 51 lung cancer patients treated off- protocol with CT and TR is higher than that reported in clinical trials. Despite higher morbidity in patients with RP (i.e., increased hospitalization), survival duration did not differ significantly based on RP status. No significant financial relationships to disclose.

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