Abstract PO-071: Defining the current state of minority recruitment into clinical trials: Perspectives of cancer center research staff

2020 ◽  
Author(s):  
Mayra Serrano ◽  
Alejandro Fernandez ◽  
Marisela Garcia ◽  
Katty Nerio ◽  
Rick Kittles
Keyword(s):  
Clinical Trials ◽  
Cancer Center ◽  
Minority Recruitment ◽  
Research Staff ◽  
Current State ◽  
Center Research

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.

Perceived Institutional Barriers Among Clinical and Research Professionals: Minority Participation in Oncology Clinical Trials

2021 ◽  
Vol 17 (5) ◽  
pp. e666-e675 ◽  
Author(s):  
Soumya J. Niranjan ◽  
Jennifer A. Wenzel ◽  
Michelle Y. Martin ◽  
Mona N. Fouad ◽  
Selwyn M. Vickers ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Community Outreach ◽  
Institutional Factors ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Minority Recruitment ◽  
Institutional Barriers ◽  
Medical Centers ◽  
Academic Medical

PURPOSE: In general, participation rates in cancer clinical trials are very low. However, participation rates are especially low among the socially disadvantaged and racial and ethnic minority groups. These groups have been historically under-represented in cancer clinical trials. Although many patient-related barriers have been studied, institutional factors that are essential for building clinical research infrastructure around the clinical trial enterprise in academic medical centers have been underexplored. MATERIALS AND METHODS: We assessed perspectives of cancer center professional stakeholders on the institutional factors that can potentially influence racial and ethnic minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five US cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Qualitative analyses examined response data focused on institutional factors related to minority recruitment for cancer clinical trials. RESULTS: Four prominent themes emerged regarding institutional barriers among clinical and research professionals. (1) There are no existing programs currently being used to recruit or retain minorities to clinical trials. (2) Institutional efforts are needed to increase trial participation and are not specific to potential minority participants. (3) Access to cancer clinical trials and navigation within an Academic Medical Center need to be simplified to better facilitate recruitment of minority patients. (4) Community outreach by cancer centers will increase clinical research awareness in the community. CONCLUSION: Our research highlights the need to address institutional barriers to improve the success of minority recruitment. To increase participation among minority populations, medical centers must address mutable institutional barriers such as setting specific minority recruitment goals for cancer clinical trials, ensuring that cancer clinical trials are accessible, especially to minority patients, and supporting sustained community outreach programs to increase clinical research awareness.

Cancer center clinic and clinical research team perceptions of identity and interactions.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18215-e18215
Author(s):  
David E. Gerber ◽  
Torsten Reimer ◽  
Sandra Garcia ◽  
Mary Gill ◽  
Tobi Duncan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Information Sharing ◽  
Care Delivery ◽  
Clinical Care ◽  
The Other ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Research Staff ◽  
Clinic Staff

e18215 Background: As evidenced by the NCI-ASCO Teams in Cancer Care Delivery initiative, there is growing interest in applying an emerging science of teams to oncology clinical care. Treatment of patients on cancer clinical trials requires coordination and cooperation among research and clinic teams. However, little empirical research has examined issues of goal alignment, diffusion of responsibility, and perceived rivalries in this setting. Methods: We developed a survey incorporating modified components of the Adapted Team Climate Inventory, the Measure of Team Identification, and the Measure of In-group Bias. Surveys were administered to research staff and clinic staff. Survey responses were analyzed using t tests and ANOVAs. Results: Responses were received from 104 staff (54 clinic, 50 research). Median duration of professional experience was 8.3 years, and median time in current position was 2.0 years. Research staff identified more strongly with their own group ( P< 0.01) but less strongly with the Cancer Center ( P= 0.02) compared to clinic staff. Both clinic and research staff viewed their own group’s goals as clearer than those of the other group ( P< 0.01). Both clinic staff and research staff felt that members of their groups shared information among themselves more than the other group ( P< 0.01). Research staff felt information sharing occurred to a greater extent in both groups than did clinic staff ( P< 0.01). Similar results were noted regarding information sharing with the other group ( Ps< 0.01). Staff indicated that members of their own groups interacted more often with each other than did members of the other group ( P< 0.01), with research staff perceiving higher interaction rates in both teams than clinic staff ( P< 0.01). Research staff perceived daily outcomes to be more important than did clinic staff ( P =0.05), in particular research-related outcomes ( P =0.07). Conclusions: Clinical research staff and clinic staff identify more strongly with their own groups and feel that their own group’s goals are clearer than those of the other group. Further study of interactions, perceptions, and attitudes between research staff and clinic staff is essential to provision of quality care to patients on cancer clinical trials.

scholarly journals Current State of Clinical Trials at Shizuoka Cancer Center, and Steps Taken to Improve Pharmaceutical Department Performance

2008 ◽  
Vol 34 (10) ◽  
pp. 956-961
Author(s):  
Yasukata Ohashi ◽  
Koji Arata ◽  
Tsukasa Muramatsu ◽  
Masashi Kimura ◽  
Michiru Sakurai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Center ◽  
Current State

Analysis of the Market, Regulatory Landscape, and Current State of Clinical Trials Pertaining to Digital Health

2018 ◽  
Vol 5 (1) ◽  
pp. 21-34
Author(s):  
Cheyenne E. Allenby ◽  
Eric S. Babiash ◽  
Patrick N. Blank ◽  
Marco D. Carpenter ◽  
Isabelle G. Lee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Digital Health ◽  
Current State ◽  
Regulatory Landscape

397 Intra-tumor immunotherapy injections utilizing image guidance in interventional radiology: clinical trial experience at a tertiary care cancer center

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A422-A422
Author(s):  
Ravi Murthy ◽  
Rahul Sheth ◽  
Alda Tam ◽  
Sanjay Gupta ◽  
Vivek Subbiah ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Interventional Radiology ◽  
Real Time ◽  
Image Guidance ◽  
Tertiary Care ◽  
Cancer Center ◽  
Imaging Guidance ◽  
Image Guided ◽  
Real Time Image ◽  
Time Image

BackgroundImage guided intra-tumor administration of investigational immunotherapeutic agents represents an expanding field of interest. We present a retrospective review of the safety, feasibility & technical nuances of real-time image guidance for injection & biopsy across a spectrum of extracranial solid malignancies utilizing the discipline of Interventional Radiology.MethodsPatients who were enrolled in image guided intratumoral immunotherapy injection (ITITI) clinical trials over a 6 year period (2013–19) at a single tertiary care cancer center were included in this analysis. Malignancy, location, imaging guidance utilized for ITITI & biopsy for injected (adscopal) & non-injected (abscopal) lesions were determined and categorized. Peri-procedural adverse events were noted.Results262 pts (146 female, 61 yrs median) participating in 29 immunotherapeutic clinical trials (TLR & STING agonists, gene therapy, anti CD-40, viral/bacterial/metabolic oncolytics) met study criteria. Malignancies included melanoma 88, sarcoma 32, colorectal 29, breast 23, lung 17, head & neck 15, ovarian 8, neuroendocrine 7, pancreatic adenocarcinoma 6, 3 each (cholangioCA, endometrial, bladder, GI tract), 2 each (RCC, thymicCA, lymphoma, merkel cell, prostate) & others 1 each (CUP, GIST, dermatofibrosarcoma, DSRT, neuroblastoma, thyroid). All 169 & 93 patients received the intended 1371 ITITI in parietal (abdominal/chest wall, extremity, neck, pelvis) or visceral (liver, lung, peritoneum, adrenal) locations respectively; 83 patients received lymph node injections within either location. Imaging guidance was US in 68% of the cohort (US 161, CT+US 19); CT was used in 30% (81) & MRI in 1 patient. Median diameter of the ITITI lesion was 32 mm (8–230 mm). Median volume of the ITITI therapeutic material/session was 2 ml (1–6.9 ml). Lesions were accessed using a coaxial technique. ITITI delivery needles used at operator preference & tailored to lesion characteristics were either a 21G/22G Chiba, 21G Profusion (Cook Medical), 22G Morrison (AprioMed), 25G hypodermic (BD) & 18G Quadrafuse (Rex Medical). 2840 core biopsies (>18G Tru-cut core, Mission, Bard Medical) were performed in 237 patients during 690 procedures; biopsy sessions were often concurrent & of the ITITI site. 137 patients also underwent biopsy of a non-ITITI site (89 parietal location). Dimensions of the non-ITITI lesion were median 10 mm (7–113 mm); US image guidance was used in 97 patients (72%) to obtain a total of 1257, >18G Tru-core samples. 1.3% of injections resulted in SAE (NCI CTC AE >3) and 0.5% of 4097 biopsies developed major complications (SIR Criteria); both categories were manageable.ConclusionsUtilizing real time image guidance, ITITI to the administration of a myriad of investigational immunotherapeutic agents with concomitant biopsy procedures to date are associated with a high technical success rate & favorable safety profile.AcknowledgementsJoshua Hein, Mara Castaneda, Jyotsna Pera, Yunfang Jiang,Shuang Liu, Holly Liu and Anna LuiTrial RegistrationN/AEthics ApprovalThe study was approved by Institution’s Ethics Board, approval number 2020-0536: A retrospective study to determine the safety, feasibility and technical challenges of real-time image guidance for intra-tumor injection and biopsy across multiple solid tumors.Consent2020-0536 Waiver of Informed ConsentReferenceSheth RA, Murthy R, Hong DS, et al. Assessment of image-guided intratumoral delivery of immunotherapeutics in patients with cancer. JAMA Netw Open 2020;3(7):e207911. doi:10.1001/jamanetworkopen.2020.7911

scholarly journals Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow

2019 ◽  
pp. 1-10 ◽  
Author(s):  
Neha M. Jain ◽  
Alison Culley ◽  
Teresa Knoop ◽  
Christine Micheel ◽  
Travis Osterman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knowledge Representation ◽  
Conceptual Framework ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Prospective Clinical Trial ◽  
Future Trends ◽  
Current State ◽  
Evaluation Strategies

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

scholarly journals The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

2019 ◽  
Vol 24 (3) ◽  
pp. 147-152 ◽  
Author(s):  
Daniel Eisenman
Keyword(s):  
United States ◽  
Gene Therapy ◽  
Clinical Trials ◽  
The United States ◽  
Regulatory Environment ◽  
Evidence Based ◽  
Regulatory Structure ◽  
Regulatory Changes ◽  
Current State ◽  
Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

scholarly journals Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

2008 ◽  
Vol 4 (4) ◽  
pp. 162-168 ◽  
Author(s):  
Michele Basche ◽  
Anna E. Barón ◽  
S. Gail Eckhardt ◽  
Lodovico Balducci ◽  
Martha Persky ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Age Groups ◽  
Experimental Treatment ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Sources Of Information ◽  
Barriers To Participation ◽  
University Center ◽  
Barriers To Enrollment

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

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