Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices

2018 ◽  
pp. 188-196 ◽  
Author(s):  
Jennifer L. Ersek ◽  
Lora J. Black ◽  
Michael A. Thompson ◽  
Edward S. Kim
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Precision Medicine ◽  
Community Setting ◽  
Successful Implementation ◽  
Precision Oncology ◽  
Community Based ◽  
Molecular Tests ◽  
Core Components ◽  
Oncology Practice

There has been a rapid uptick in the pace of oncology precision medicine advancements over the past several decades as a result of increasingly sophisticated technology and the ability to study more patients through innovative trial designs. As more precision oncology approaches are developed, the need for precision medicine trials is increasing in the community setting, where most patients with cancer are treated. However, community-based practices, as well as some academic centers, may face unique barriers to implementing precision medicine programs and trials within their communities. Such challenges include understanding the tissue needs of molecular tests (e.g., tumor, blood), identifying which molecular tests are best used and when tissue should be tested, interpreting the test results and determining actionability, understanding the role of genetic counseling and/or follow-up testing, determining clinical trial eligibility, and assessing patient attitudes and financial concerns. The purpose of this article is to provide guidance to community-based oncology practices currently conducting clinical trials who want to expand their research program to include precision medicine trials. Here, we describe the core components of precision medicine programs and offer best practices for successful implementation of precision medicine trials in community-based practices.

scholarly journals Implementing Precision Medicine in Community-Based Oncology Programs: Three Models

2019 ◽  
Vol 15 (6) ◽  
pp. 325-329 ◽  
Author(s):  
Laura A. Levit ◽  
Edward S. Kim ◽  
Barbara L. McAneny ◽  
Lincoln D. Nadauld ◽  
Kathryn Levit ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Cancer Care ◽  
Large Scale ◽  
Administrative Support ◽  
Clinical Pathways ◽  
Clinical Decision ◽  
Successful Implementation ◽  
Precision Oncology ◽  
Community Based ◽  
Tumor Boards

The use of precision medicine and the number of genomic-based treatments and immunotherapies is increasing. Nevertheless, oncology providers face challenges to implementing precision medicine, including in community practices, where most patients receive treatment. On January 31, 2018, ASCO hosted Precision Medicine: Expanding Opportunities, the inaugural event in ASCO’s new State of Cancer Care in America (SOCCA) event series. This article draws from the inaugural SOCCA event and the experiences of the SOCCA event participants to summarize the opportunities and challenges of precision medicine, and to highlight three successful models of implementing precision oncology in large, multisite community practices or networks: (1) Intermountain Healthcare, (2) Levine Cancer Institute, Atrium Health, and (3) National Cancer Care Alliance. The experience of these practices suggests that practice innovations that offer clinical decision support through molecular tumor boards and clinical pathways, and administrative support for prior authorization and clinical trial matching are key to successful implementation of large-scale, community-based precision medicine programs.

Cancer clinical trials available in the community setting: A 5-year analysis from 1999–2004

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6056-6056
Author(s):  
J. K. Keller ◽  
J. Bowman ◽  
J. A. Lee ◽  
M. A. Mathiason ◽  
K. A. Frisby ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Community Setting ◽  
Disease Stage ◽  
Cancer Center ◽  
Newly Diagnosed ◽  
Community Based ◽  
Eligibility Criteria ◽  
Major Barrier

6056 Background: Less than 5% of newly diagnosed cancer patients are accrued into clinical trials. In the community setting, the lack of appropriate clinical trials is a major barrier. Our prospective study in 2004 determined that 58% of newly diagnosed adult cancer patients at our community-based cancer center didn’t have a clinical trial available appropriate for their disease stage. Among those with clinical trials, 23% were subsequently found to be ineligible (Go RS, et al. Cancer 2006, in press). However, the availability of clinical trials may vary from year to year. Methods: A retrospective study was conducted to determine what clinical trials were available for newly diagnosed adult cancer patients at our institution from June 1999-July 2004. The study also investigated the proportions of newly diagnosed patients who had a clinical trial available appropriate for type and stage of disease and patients accrued. Results: Over the 5-year period, 207 (82, 87, 99, 102, 117, years 1–5, respectively) trials were available. Most (50.7%) trials were for the following cancers: breast (15.5%), lung (13.5%), head and neck (7.7%), colorectal (7.2%) and lymphoma (6.8%). ECOG (53%), RTOG (26%), and CTSU (9%) provided the majority of the trials. A total of 5,776 new adult cancer patients were seen during this period. Overall, 60% of the patients had a trial available appropriate for type and stage of their cancer, but only 103 (3%) were enrolled. There was a significant upward trend in the proportions of patients with available trials over the years (60.2%, 55.9%, 59.2%, 60.7%, 63.9%, years 1–5, respectively; Mantel-Haenszel P=.008). The proportion of patients with a trial available was highest for prostate (97.3%), lung (90.9%), and breast (73.9%), and lowest for melanoma (17.1%), renal (11.6%), and bladder (7.2%). The majority of patients accrued to trials had the following cancers: breast (32%), lung (17%), lymphoma (9%), colon (7%), and prostate (5%). Conclusions: Nearly half of the newly diagnosed adult patients at our center had no trials available appropriate for type and stage of their cancers. It is likely that if strict clinical trial eligibility criteria were applied, approximately 2/3 of our patients would not be eligible for a clinical trial. No significant financial relationships to disclose.

scholarly journals Challenges With Research Contract Negotiations in Community-Based Cancer Research

2016 ◽  
Vol 12 (6) ◽  
pp. e626-e632 ◽  
Author(s):  
Michael A. Thompson ◽  
Patricia A. Hurley ◽  
Bryan Faller ◽  
Jean Longinette ◽  
Katie Richter ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Community Setting ◽  
Community Research ◽  
Community Based ◽  
Community Based Research ◽  
Contract Negotiations ◽  
Contract Research ◽  
Research Organizations ◽  
Negotiation Processes ◽  
Research Contract

Purpose: Community-based research programs face many barriers to participation in clinical trials. Although the majority of people with cancer are diagnosed and treated in the community setting, only roughly 3% are enrolled onto clinical trials. Research contract and budget negotiations have been consistently identified as time consuming and a barrier to participation in clinical trials. ASCO’s Community Research Forum conducted a survey about specific challenges of research contract and budget negotiation processes in community-based research settings. The goal was to ultimately identify potential solutions to these barriers. Methods: A survey was distributed to 780 community-based physician investigators and research staff. The survey included questions to provide insight into contract and budget negotiation processes and perceptions about related barriers. Results: A total of 77% of the 150 respondents acknowledged barriers in the process. Respondents most frequently identified budget-related issues (n = 133), inefficiencies in the process (n = 80), or legal review and negotiation issues (n = 70). Of the respondents, 44.1% indicated that contract research organizations made the contract negotiations process harder for their research program, and only 5% believed contract research organizations made the process easier. The contract negotiations process is perceived to be impeded by sponsors through underestimation of costs, lack of flexibility with the contract language, and excessive delays. Conclusion: Improving clinical trial activation processes and reducing inefficiencies would be beneficial to all interested stakeholders, including patients who may ultimately stand to benefit from participation in clinical trials. The following key recommendations were made: standardization of contracts and negotiation processes to promulgate transparency and efficiencies, improve sponsor processes to minimize burden on sites, create and promote use of contract templates and best practices, and provide education and consultation.

scholarly journals Implementation and Clinical Utility of an Integrated Academic-Community Regional Molecular Tumor Board

2017 ◽  
pp. 1-10 ◽  
Author(s):  
Mark E. Burkard ◽  
Dustin A. Deming ◽  
Benjamin M. Parsons ◽  
Paraic A. Kenny ◽  
Marissa R. Schuh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Precision Medicine ◽  
Clinical Utility ◽  
Journal Club ◽  
Academic Community ◽  
Tumor Board ◽  
Observational Research ◽  
Evidence Based ◽  
Precision Oncology ◽  
Molecular Tumor Board

Purpose Precision oncology develops and implements evidence-based personalized therapies that are based on specific genetic targets within each tumor. However, a major challenge that remains is the provision of a standardized, up-to-date, and evidenced-based precision medicine initiative across a geographic region. Materials and Methods We developed a statewide molecular tumor board that integrates academic and community oncology practices. The Precision Medicine Molecular Tumor Board (PMMTB) has three components: a biweekly Web-based teleconference tumor board meeting provided as a free clinical service, an observational research registry, and a monthly journal club to establish and revise evidence-based guidelines for off-label therapies. The PMMTB allows for flexible and rapid implementation of treatment, uniformity in practice, and the ability to track outcomes. Results We describe the implementation of the PMMTB and its first year of activity. Seventy-seven patient cases were presented, 48 were enrolled in a registry, and 38 had recommendations and clinical follow-up. The 38 subjects had diverse solid tumors (lung, 45%; GI, 21%; breast, 13%; other, 21%). Of these subjects, targeted therapy was recommended for 32 (84%). Clinical trials were identified for 24 subjects (63%), and nontrial targeted medicines for 16 (42%). Nine subjects (28%) received recommended therapy with a response rate of 17% (one of six) and a clinical benefit rate (partial response + stable disease) of 38% (three of eight). Although clinical trials often were identified, patients rarely enrolled. Conclusion The PMMTB provides a model for a regional molecular tumor board with clinical utility. This work highlights the need for outcome registries and improved access to clinical trials to pragmatically implement precision oncology.

scholarly journals Best practices addressing healthcare care access of migrants and refugees in European countries

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
E Riza ◽  
S Kalkman ◽  
P Karnaki ◽  
D Zota ◽  
A Gil-Salmerón ◽  
...  
Keyword(s):  
Best Practices ◽  
Service Providers ◽  
Well Being ◽  
Literacy Skills ◽  
Host Community ◽  
European Countries ◽  
Cultural Barriers ◽  
Successful Implementation ◽  
Community Based ◽  
Major Facilitator

Abstract Mig-healthCare has identified sources in the countries and languages of the consortium providing guidance for community-based healthcare for migrants and refugees. A total of 54 sources that refer to best practices in seven European countries were identified. Results were categorized along with the themes: organization, communication, training, education and facilities & services. Successful organizational measures were a close collaboration with different governmental authorities, NGOs, community organizations and various local service providers. Moreover, engagement with members from both the host community and the migrant/refugee community in the design and implementation phases is essential. The need to track all activities through data collection and periodic evaluations is important in order to evaluate the effectiveness of systems. Funding was mentioned as important to secure continuity of projects and systems. Bridging communication barriers is a major facilitator to reduce health disparities. Differences in the types of practices and challenges per country were noted. Translators and cultural mediators are a key element in successful implementation, but across EU there is a need for more specialized staff to face the cultural barriers of the large variation in refugee/migrant backgrounds. The empowerment of migrants/refugees in promoting well-being through the engagement of the host community to help reduce stigma and discrimination is a successful strategy facilitating the access to care due to the increase of their health literacy skills. Finally, tailored services to give an answer to the specific needs of migrants and refugees are important, for example at first reception centres, standard medical screening and psychosocial risk assessment was recommended. Through this analysis, we can distinguish community-based care models elements facilitating the access of migrants and refugees to healthcare.

scholarly journals A Roadmap to Inform the Implementation of Evidence-Based Collaborative Care Interventions in Communities: Insights From the Michigan Mental Health Integration Partnership

2021 ◽  
Vol 9 ◽  
Author(s):  
Amy Rusch ◽  
Lindsay M. DeCamp ◽  
Celeste M. Liebrecht ◽  
Seo Youn Choi ◽  
Gregory W. Dalack ◽  
...  
Keyword(s):  
Mental Health ◽  
Best Practices ◽  
Collaborative Care ◽  
Project Teams ◽  
Successful Implementation ◽  
Evidence Based ◽  
Structured Interviews ◽  
Community Based ◽  
Mental Health Integration ◽  
Implementation Steps

Background: Despite increasing calls for further spread of evidence-based collaborative care interventions (EBIs) in community-based settings, practitioner-driven efforts are often stymied by a lack of experience in addressing barriers to community-based implementation, especially for those not familiar with implementation science. The Michigan Mental Health Integration Partnership (MIP) is a statewide initiative that funds projects that support implementation and uptake of EBIs in community-based settings. MIP also provides an in situ implementation laboratory for understanding barriers to the uptake of EBIs across a variety of settings. We report findings from a statewide qualitative study of practitioners involved in MIP projects to garner their perspectives of best practices in the implementation of EBIs.Methods: Twenty-eight semi-structured interviews of practitioners and researchers from six MIP Projects were conducted with individuals implementing various MIP EBI projects across Michigan, including stakeholders from project teams, implementation sites, and the State of Michigan, to identify common barriers, challenges, and implementation strategies deployed by the project teams, with the purpose of informing a set of implementation steps and milestones.Results: Stakeholders identified a number of barriers to and strategies for success, including the need for tailoring program deployment and implementation to specific site needs, development of web-based tools for facilitating program implementation, and the importance of upper-level administration buy-in. Findings informed our resultant community-based Implementation Roadmap, which identifies critical steps across three implementation phases—pre-implementation, implementation, and sustainability—for implementation practitioners to use in their EBI implementation efforts.Conclusion: Implementation practitioners interested in community-based EBI implementation often lack access to operationalized implementation “steps” or “best practices” that can facilitate successful uptake and evaluation. Our community-informed MIP Implementation Roadmap, offering generalized steps for reaching successful implementation, uses experiences from a diverse set of MIP teams to guide practitioners through the practices necessary for scaling up EBIs in community-based settings over pre-implementation, implementation and sustainability phases.

The rate of novel actionable mutations in standard of care NGS panel testing in gastrointestinal malignancies.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 640-640
Author(s):  
Amir Mehrvarz Sarshekeh ◽  
Jonathan Loree ◽  
Allan Andresson Lima Pereira ◽  
Kanwal Pratap Singh Raghav ◽  
Michael Lam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Success Rate ◽  
Standard Of Care ◽  
Cancer Center ◽  
Precision Oncology ◽  
Gastrointestinal Malignancies ◽  
Genetic Profiling ◽  
Variants Of Unknown Significance ◽  
Panel Testing ◽  
Oncology Practice

640 Background: In advanced gastrointestinal (GI) malignancies, genetic profiling is often performed with the goal of facilitating enrollment of patients into clinical trials. While multigene genetic profiling has become the standard of care in many practices, the data on success rate of identifying actionable genomic alterations remain limited. In this study, we aimed to characterize the rate of actionable mutations using larger ( > 150 genes) and smaller ( < 150 genes) panels across different GI malignancies. Methods: We reviewed all reports of formalin-fixed paraffin-embedded clinical specimens sent for next-generation sequencing (NGS-using assays of at least 45 genes) for patients with advanced GI malignancies between 2012-2017 at MD Anderson Cancer Center. Actionable mutations were defined as those matching or informing the use of targeted therapies available in clinical trials, or FDA-approved. These were determined by a precision oncology support team (pct.mdanderson.org), using available literature and functional genomic screens. Novel actionable mutations were defined as those not used in current testing guidelines for GI malignancies. Results: Out of 11968 detected mutations, 3832(32.0%) were deemed to be actionable mutations and the remainder were either in non-actionable genes, deemed benign, or variants of unknown significance. Therefore, 1987 (65.1%) of assays had actionable mutations. When limited to novel actionable mutations, the rate fell to 21.5% (659/3052). Compared to CRC, other GI malignancies were 1.65 times more likely to have a novel actionable mutation (95% CI 1.35-2.00, p< .001). The use of larger and smaller panels did not differ in detecting novel actionable mutations, but larger panels resulted in a 3.5-fold higher number of mutations not deemed clinically actionable. Conclusions: Despite incorporation of NGS in oncology practice for GI malignancies, the success rate of detecting novel actionable mutations beyond those in the current guidelines remains low. Using assays with larger gene numbers does not seem to improve this detection rate. Future studies are required to evaluate the success rate of clinical interventions when actionable alterations are present.

Utilizing QOPI in the quality improvement efforts of the NCI Community Cancer Centers Program (NCCCP).

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 208-208
Author(s):  
Robert D. Siegel ◽  
Holley Stallings ◽  
Donna M. Bryant ◽  
Pamela Kadlubek ◽  
Laurel Borowski ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Quality Of Care ◽  
Best Practices ◽  
New England ◽  
Community Based ◽  
Quality Initiatives ◽  
Cancer Centers ◽  
High Performing ◽  
Oncology Practice

208 Background: The NCCCP is a network of community based institutions from New England to Hawaii funded by the NCI. Quality of care is a priority of the NCCCP with participation in ASCO’s Quality Oncology Practice Initiative (QOPI) playing a fundamental role. QOPI provides a process for quality assessment but we have also used it as a measure of quality improvement (QI) network-wide. Using QOPI methodology, we have analyzed our performance twice a year in an effort to enhance our implementation of quality indicators relevant to program aims. Methods: A data sharing agreement allows individual practice QOPI data to be electronically sent to the NCI where it is aggregated with the other NCCCP QOPI participants. Data are presented via webinar within the network using a variety of QI strategies. For example, blinded site performance distributions are benchmarked against NCCCP national averages on specific indicators. High performing practices voluntarily present their QI initiatives and best practices to the network. The NCCCP Quality of Care Subcommittee then selects QI projects and areas to focus quality improvement efforts. Results: In Spring 2012, 44 practices affiliated with 25 NCCCP sites participated in QOPI, a consistent pattern since Fall 2010. The table below describes the percent compliance with certain QOPI measures for the NCCCP aggregate over time. Selected measures were perceived as having had suboptimal compliance in Fall 2010. Conclusions: QOPI is an effective tool for assessing quality within a network and for measuring quality improvement efforts. Best practices from within the network can be leveraged and disseminated to enhance the quality of cancer care. This methodology facilitates quality initiatives despite the logistical challenges of working with practices across the country. [Table: see text]

Utilization of consultative molecular tumor board in community setting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6508-6508 ◽  
Author(s):  
Carol J. Farhangfar ◽  
Oshuna Morgan ◽  
Charlene Concepcion ◽  
Jimmy J. Hwang ◽  
Kathryn Finch Mileham ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Community Setting ◽  
Treatment Decisions ◽  
Tumor Board ◽  
Baseline Survey ◽  
Community Based ◽  
Tumor Boards ◽  
Molecular Tumor Board ◽  
Tumor Types ◽  
Genomics Education

6508 Background: Physicians in the community have a broad range of experience using genomics data to inform treatment decisions. They typically have a heavier patient load than found in academic centers and treat a variety of tumor types. Genomic data has been reportedly used less than anticipated, even when results were actionable. Monthly didactic molecular tumor boards have been implemented in a number of cancer centers to try to fill gaps in knowledge. Methods: A weekly virtual consultative molecular tumor board (MTB) was implemented (Mar 2016) at an academic hybrid, multi-site community-based cancer institute to provide rapid molecularly-driven treatment guidance to physicians, augment genomics education, provide supporting documents for off-label use and clinical trials. A baseline survey was performed prior to first MTB. MTB assessments were summarized and provided to treating physician. Data was abstracted from the electronic medical records and clinical trials management system. Descriptive statistics were utilized to summarize utilization of MTB and treatment recommendations. Results: Genomics testing with a large panel (~600 genes) was requested for 809 patients (Jun 2015-Feb 2017). The MTB received 81 requests for review from 32 physicians from 14 locations. Most commonly reviewed disease sites were lung, ovary, pancreatic, colon, breast and head and neck cancers; 37% of reviews requested were for rare tumors. Median time to review request was 15 days from receipt of results. MTB recommendations were followed in 70% of cases, 16% continued current/other therapy, 11% declined rapidly (hospice/died), and 3% of patients decided against recommendations. Forty-four (44) percent were screened for recommended clinical trials; 26% went on study. Conclusions: Implementation of a weekly virtual consultative MTB facilitates molecularly-driven treatment decisions in community setting, especially in rare tumor types and enhances clinical trial accruals.

Sign in / Sign up

Export Citation Format

Share Document