Impact of nontreatment oncology research trials on physician engagement in clinical research in an oncology community practice setting.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 44-44
Author(s):  
Susan S. Night ◽  
Juston S. Roemisch ◽  
David A. Smith
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Negative Impact ◽  
Rapid Development ◽  
Treatment Options ◽  
Community Practice ◽  
Oncology Research ◽  
Community Oncology ◽  
Physician Engagement

44 Background: The rapid development of new oncology drugs has created a significant increase in the number of clinical research studies. This underscores the need for greater participation in research by physicians as well as patients. Many physicians hesitate to participate in oncology clinical trials that provide treatment options for their patients given the complexity of the protocols. Non-treatment clinical trials may serve as a bridge for engaging physicians in clinical research and enhance the culture of research in community oncology practices. Methods: A large non-treatment oncology clinical trial was opened in a network of community oncology practices with approximately 1,000 physicians. We evaluated the number of physicians who did not enroll a patient onto a clinical trial in Year 1 but did enroll patients onto the non-treatment study. We further examined the number of physicians who enrolled a patient onto the non-treatment study that also enrolled patients onto a treatment clinical trial. Overall physician engagement in clinical research was measured by comparing practices where non-treatment study was offered to locations that did not participate in the non-treatment study. Negative impact on treatment accruals was also evaluated. Results: There were 105 physicians that practice at a site with the non-treatment study who had 0 accruals in Year 1 but enrolled a patient to any clinical trial in Year 2. Ninety-two of those physicians were responsible for enrolling over 900 patients to the non-treatment study in Year 2. Additionally, 46 of the 0 accruing physicians in Year 1, enrolled a patient to the non-treatment study also enrolled a patient to a treatment clinical trial. We also found that 24 physicians who did not did not enroll a patient in Year 1 and did not enroll a patient to the non-treatment study did enroll patients to a treatment clinical trial in Year 2. Conclusions: Participation in oncology treatment clinical trials can be difficult in the community oncology setting. Participation in a non-treatment study may serve as a bridge to engage more physicians in clinical research and enhance the culture of research within a community oncology practice.

Community and academic partnerships: Moving a new generation of clinical trials in NCI Community Oncology Research Program (NCORP) into community oncology practices.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2551-2551
Author(s):  
Worta J. McCaskill-Stevens ◽  
Ann M. Geiger
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Cost Of Care ◽  
Community Practice ◽  
Effective Strategies ◽  
Oncology Research ◽  
Research Activities ◽  
Community Oncology ◽  
Catchment Areas

2551 Background: NCORP is a model program that bridges academic and community oncology practices and research. Over the past decade, community cancer investigators have adopted new technology, encountered new treatment sequalae, and faced rising cost of care with its financial toxicity imposed upon individuals seeking care. Opportunities are abundant for community investigators to assess feasibility and uptake of research advances into community practice settings, yet these opportunities are met with the challenges of dynamic changes in types of organizations delivering cancer care and diversity of populations within their catchment areas. Little information is shared about how and to what extent the health environment influences this partnership and the implementation of a broad cancer research portfolio. Methods: This abstract reports on the continued interest and participation of community oncologists in research which is demonstrated by 987 practices with over 4000 investigators in NCORP. Since 2014, over 30,000 individuals enrolled in symptom management, screening, surveillance, quality of life, and treatment trials. An additional 4500 patients and clinicians have enrolled in care delivery studies. Results: NCORP has been central in evaluating the most effective strategies for investigators to effectively communicate to patients the science of genomically-driven trials. It has also provided ways of bringing the pediatric and AYA patients access to the most up-to-date treatment strategies and new therapies in their community. This creates the least disruption on family structure/dynamics, diminished traveling requirements/costs, and reduced the financial burden. NCORP promotes involvement of treating oncologists in research activities. This also improves care for patients not enrolled in clinical trials. Therefore, NCORP serves as a laboratory to determine the most effective strategies for co-management of cancer patients and survivors. Conclusions: Several questions however remain to be addressed using this clinical trial model. These include: how to continue to reduce disparities in cancer care and clinical trial participation; and, what are the best strategies for fostering implementation of cancer care models in community practice.

A novel approach to support community oncology practices in building a clinical research program.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18087-e18087
Author(s):  
Jeremy Miller ◽  
Debra A. Kientop ◽  
Linda Andrews ◽  
William Jeffery Edenfield ◽  
David Hadley
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Research Program ◽  
Professional Services ◽  
Novel Approach ◽  
Community Oncology ◽  
Number Of Patients ◽  
Clinical Trial Enrollment ◽  
Building Program

e18087 Background: Starting a clinical research program in a community oncology setting has a myriad of challenges. While ASCO provides guidance through its “Basic Requirements for Starting a Research Practice”, building a research program requires significant time and effort. We present an example of how a technology-enabled solution supports a consortium of community oncology practices to rapidly grow their clinical research program, as they strive to meet the Commission on Cancer goal of > 4% clinical trial enrollment. Methods: Four key pillars that support a successful research program include: building program infrastructure, establishing standard operating procedures, engaging patients and accessing clinical trials. The consortium receives support for each of these components through a combination of software tools and professional services. Results: The practices in the consortium currently have clinical trial enrollment that is less than desired, but the number of patients on clinical trials in the consortium for coming year is expected to grow between two and ten-fold. The table below shows the enrollment by site in 2018 for the 7 practices that have been engaged for the full year. Candidates are patients who have found to be eligible for at least one clinical trial, but have not yet been enrolled or declined. Conclusions: The practices have been engaged in the consortium for approximately one year. While some practices are well below their eventual target of 4% enrollement, the increasing number of patients screened, and their growing clinical trial portfolio of well-matched clinical trials has them well on their way to that target over the next two years.[Table: see text]

scholarly journals Understanding the Barriers to Pediatric Oncologist Engagement and Accrual to Clinical Trials in National Cancer Institute–Designated Community Oncology Research Programs

2020 ◽  
pp. JOP.19.00707 ◽  
Author(s):  
David S. Dickens ◽  
Michael E. Roth ◽  
Brad H. Pollock ◽  
Anne-Marie Langevin
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Time Allocation ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Clinical Trial Research ◽  
Protected Time ◽  
Oncology Research ◽  
Community Oncology

PURPOSE: Clinical trial participation leads to progress in cancer care. Principal investigators (PIs) and clinical research associates (CRAs) play key roles in the provision and maintenance of clinical trial portfolios at their sites. Previous studies have evaluated the educational and resource needs of adult oncology providers, but nothing to date has focused on providers of pediatric oncology care. We aimed to identify the educational needs and clinical trial participation barriers at National Cancer Institute Community Oncology Research Program (NCORP) Children’s Oncology Group (COG) sites to improve the quality of site investigator engagement. METHODS: Quality improvement surveys of pediatric clinical research staff at NCORP sites were performed. The first was a web-based inquiry of NCORP COG PIs and lead CRAs to assess their general understanding of NCORP organizational structure and needs. The second survey of COG PIs was conducted by one-on-one telephone interviews aimed at identifying specific barriers to physician engagement and patient enrollment in clinical trial research. RESULTS: The majority of NCORP COG PIs and CRAs (63%) reported an incomplete understanding of NCORP structure, with approximately half expressing interest in developing stronger collaborations and engagement. Most NCORP COG PIs reported at least one shared barrier to clinical trial enrollment (78%), with inadequate protected time and research support (39% each) being the most frequently cited barriers. CONCLUSIONS: Contributions to pediatric cancer clinical research at COG NCORP sites could be enhanced through improved education, resources, and time allocation.

scholarly journals A Review on Virtual Clinical Trials: The Future

2021 ◽  
Vol 68 (1) ◽  
Author(s):  
Swaroop Narayanasetty ◽  
Dr. Ravindra Jallu
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Social Engagement ◽  
Negative Impact ◽  
Wearable Sensors ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sleep Cycle ◽  
Patient Counseling

A clinical trial is a study designed to demonstrate the efficacy and safety of a drug, procedure, medical device, or diagnostic test. Since clinical trials involve research in humans, they must be carefully designed and must comply strictly with a set of ethical conditions. Logistical disadvantages, ethical constraints, costs and high execution times could have a negative impact on the execution of the clinical trial. Rapid innovation in health and health care technologies, interventions, and products require the proliferation of rigorous clinical trials to evaluate their efficacy and effectiveness. To meet these needs, the field has been slowly moving toward increasing adoption of virtual clinical trials. VCTs use tech devices and social engagement platforms to conduct trials from a patient’s home. These electronic processes offer new opportunities for a patient-centric approach to clinical research. So that the participant does not require travel to a clinical research site. The subject can participate from home using mobile device or a wearable gadget (maybe a phone, watch, or even glasses) is linked to the clinical research study. These wearable sensors record data such as body temperature and blood glucose levels, Spo2, Heart rate, Sleep cycle which are sent automatically to the study electronic data capture (EDC) record. The subjects are recruited through notifications instead of newspapers or doctors clinic, informed consent (Eligible participants are selected through screening followed by e-consent which is a set of Presentations followed by questionnaires to the participants), patient counseling, through to measuring clinical endpoints and adverse reactions (ADRs are reported to Adverse event reporting system). To conclude, until now VCTs have been used in Phase II-IV trials. Results from these trials have shown promising results. Besides, it has also been able to meet the goal of the pharma industry (low risk and high return) when conducting clinical trial

Patients’ perceptions of care coordination among NCORP therapeutic clinical trial participants: A matched case-control study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13504-e13504
Author(s):  
Izumi Okado ◽  
Ian Pagano ◽  
Jessica Rhee ◽  
Jeffrey L. Berenberg ◽  
Randall F. Holcombe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Care Coordination ◽  
Cancer Care ◽  
Healthcare Delivery ◽  
Cancer Clinical Trials ◽  
Cancer Type ◽  
Oncology Research ◽  
Domain Scores

e13504 Background: Effective coordination of care (CC) is a critical component of high-quality cancer care; however, many patients with cancer continue to receive poorly coordinated care. CC experiences among therapeutic clinical trial (CT) participants are relatively unknown. We examined cancer patients’ perceptions of CC among CT participants using a validated Care Coordination Instrument (CCI). Methods: The study sample (N = 90) consisted of 45 CT participants and 45 matched non-participants from archival data from our prior CC studies. 171 patients who participated in therapeutic cancer clinical trials through the Hawaii Minority/Underserved NCI Community Oncology Research Program (NCORP) between 2015 and 2020 were contacted for study participation, and 26% completed the CCI. The CCI measures overall perceptions of CC and across 3 domains (Communication, Navigation, Operational). Paired t-tests were used to compare overall and domain scores between CT participants and non-participants. The two groups were matched by age, gender, cancer type (breast, GI, other), and clinical stage. Results: Among CT participants, the mean age was 61.7 ( SD = 9.4), and the majority were female (67%) and Asian (56%). The most common cancer types were breast (27%) and GI (16%), with 24% with stage III disease. CT participants reported significantly higher total CC scores than non-participants (62.5 vs. 55.8; p = .0008). Similar trends were found for Navigation ( p = .007) and Operational ( p = .001) domain scores. 29% of CT participants reported receiving high-intensity CC assistance from their clinical research associates (CRAs), and 27% indicated receiving moderate-level CC assistance. Responses to open-ended questions regarding CC revealed that CT participants received assistance with a variety of CC activities from their CRAs, including scheduling appointments and explaining test results and procedures. Conclusions: Patients who participate in therapeutic cancer clinical trials report more positive perceptions of CC compared to non-participants. Qualitative data suggest that significant care coordination support is provided by the clinical research associate. The results underscore the importance of CC support provided by CRAs who may be an unrecognized component of the healthcare delivery team. CC provided by CRAs may contribute to improved quality and value of cancer care for patients enrolled on therapeutic clinical trials.

scholarly journals A community-centered approach to sickle cell disease and clinical trials participation: an evaluation of perceptions, facilitators, and barriers

2021 ◽  
Author(s):  
LaTasha H Lee ◽  
LaShanta H Whisenton ◽  
Jasmine Benger ◽  
Sophie Lanzkron
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Sickle Cell Disease ◽  
Clinical Research ◽  
Sickle Cell ◽  
Treatment Options ◽  
The United States ◽  
Personal Health Information ◽  
Cell Disease

Sickle cell disease (SCD) is the most common inherited red blood cell disorder in the United States, affecting 70,000-100,000 Americans and causing a range of serious medical complications. Although the cause of SCD was established decades ago, existing therapies have varied effectiveness and side effects, and novel therapies have been slow to develop. The limitations of existing treatment options highlight the need for new therapies that are aligned with the desires of the community. To date, little has been done to systematically seek and report the opinions and experiences of people with SCD regarding clinical research. In 2019, the American Society of Hematology Research Collaborative (ASH RC) conducted eight community workshops across the United States engaging 472 people, including persons with SCD and caregivers of those living with the disease. The workshop goals included assessing understanding, awareness, and perceptions of clinical research; and identifying the most critical clinical trial considerations of this community. Participants were asked about their experiences living with SCD and their satisfaction with treatment options. Pain and fatigue were reported as symptoms requiring better therapies. Although few participants reported being asked to enroll in a clinical trial, they expressed conditional willingness to participate. A majority were willing to share personal health information to further research and improve health outcomes. To actively engage the SCD community and increase enrollment and retention in clinical trials, researchers should address the treatment priorities of this population and ensure they have access to trusted information about clinical research and opportunities for participation.

Role of oncology-advanced practitioners to enhance clinical research.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 95-95
Author(s):  
Christa Marie Braun-Inglis ◽  
Leigh Boehmer ◽  
Laura J Zitella ◽  
Brianna Hoffner ◽  
Jessica Rhee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Care Providers ◽  
Nurse Practitioners ◽  
Cancer Care ◽  
Treatment Options ◽  
Physician Assistants ◽  
Full Potential ◽  
Care Providers

95 Background: Oncology Advanced Practitioners (APs), including Nurse Practitioners, Physician Assistants, Clinical Nurse Specialists, and Pharmacists are highly trained health care providers that contribute significantly to quality cancer care. Given low clinical trial enrollment among adult oncology patients, understanding current research responsibilities of APs could lead to identification of opportunities to leverage this workforce to enhance accrual and conduct of clinical trials. Methods: A 65-item validated survey addressing attitudes, beliefs and responsibilities of oncology APs participating in clinical research was distributed from January 22 through March 6, 2020. Outreach via the Association of Community Cancer Centers (ACCC) and Harborside was utilized to reach a sample set of 14,601 oncology APs’ emails. The survey was administered and data were analyzed using Survey Monkey. Results: 408 U.S. oncology APs completed the survey. Respondents were primarily white (83%), female (92%) and nurse practitioners (71%). Thirty-five percent practiced in an academic setting and 62% practiced in a community setting. Nearly all respondents believed that clinical trials are important to improve oncology care standards and more than 90% reported that clinical trials were available at their practice. Nearly 80% reported that they are comfortable discussing treatment options with patients, discussing clinical trials in general, and know where to find clinical trials. Furthermore, 80% participate in the care of patients enrolled on clinical trials. Only 60%, however, are comfortable discussing trials available at their practice and only 38% routinely explore whether a clinical trial is available for their patients. While 70% of APs approach eligible patients about clinical trials at their practice, only 20% reported doing so “a great deal” or “a lot”. Ninety percent of APs reported that they should play a role in clinical research and 75% would like to be more involved in the clinical trial process. Barriers to greater involvement in clinical trials include lack of time, inadequate awareness of clinical trial specifics, and under-representation on research committees. Conclusions: The majority of oncology APs are engaged and interested in clinical trials and believe that research is important to improve cancer care. However, they are not being utilized to their full scope. Multidisciplinary team integration, trials-related education, and policy change is needed to allow this group of skilled professionals to realize their full potential within cancer clinical trials.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

Practical Aspects of Implementing and Applying Health Care Cloud Computing Services and Informatics to Cancer Clinical Trial Data

2021 ◽  
pp. 826-832
Author(s):  
Jay G. Ronquillo ◽  
William T. Lester
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Cancer Research ◽  
Cloud Computing ◽  
Clinical Trials ◽  
Laboratory Tests ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Precision Oncology ◽  
Oncology Research

PURPOSE Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process. METHODS We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis. RESULTS There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov ( P < .001). Cloud-based entity analysis of clinical trial criteria identified a total of 949 genes, 1,782 laboratory tests, 2,086 medications, and 4,902 National Cancer Institute Thesaurus terms, with estimated detection accuracies ranging from 12.8% to 89.9%. A total of 77,702 API calls processed an estimated 167,179 text records, which took a total of 1,979 processing-minutes (33.0 processing-hours), or approximately 1.5 seconds per API call. CONCLUSION Current general-purpose cloud health care tools—like the Google service in this study—should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.

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