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.

The New National Cancer Institute National Clinical Trials Network

2012 ◽  
pp. 146-148 ◽  
Author(s):  
Stephen S. Grubbs
Keyword(s):  
Cancer Research ◽  
Clinical Trials ◽  
National Cancer Institute ◽  
Community Setting ◽  
Cooperative Group ◽  
Group Program ◽  
Community Based ◽  
Community Based Research ◽  
Efficiency And Effectiveness ◽  
Oncology Clinical Trials

Overview: The National Cancer Institute (NCI) Cooperative Group Program has been reviewed by three published studies in the last 7 years evaluating the efficiency and effectiveness of this national oncology clinical trials system. The recommendations for improvement from these reports have prompted NCI to transform the Cooperative Group Program into a new NCI National Clinical Trials Network (NCTN) to improve the efficiency of large clinical trials and increase the speed of cancer translational research. The new NCTN offers community-based clinical investigators new opportunities to advance cancer research in their community setting but also presents challenges in promoting community-based research.

scholarly journals ASCO's Community Research Forum: Addressing Challenges of Community-Based Research from the Grass Roots

2014 ◽  
pp. e111-e115
Author(s):  
Nicholas Robert ◽  
Rogerio Lilenbaum ◽  
Patricia Hurley
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Assessment Tool ◽  
Community Research ◽  
Trial Participation ◽  
Community Based ◽  
Community Based Research ◽  
Research Programs ◽  
Clinical Research Associates ◽  
Conducting Research

ASCO's Community Research Forum is a solution-oriented venue for community research sites to overcome barriers to conducting clinical trials. The key objectives of the Forum are to (1) convene community-based researchers to identify challenges to conducting research that ASCO can address, (2) develop solution-oriented projects to address these challenges to facilitate clinical trial participation in community research settings, and (3) shape ASCO programs and policies to support members engaged in community research. The Community Research Forum holds an annual in-person meeting that convenes physician investigators, research administrators, research nurses, and clinical research associates from community-based research programs and practices. To meet identified needs, the Community Research Forum has developed the ASCO Clinical Trial Workload Assessment Tool and the ASCO Research Program Quality Assessment Tool. Both of these tools will be available to the public in 2014. The Forum is currently exploring the concept and potential metrics of a research certification program to formally assess community-based research programs, and to identify gaps and areas to improve the program in order to meet quality standards. The Community Research Forum's website aims to serve as a go-to resource for community-based physician investigators and research staff. The Community Research Forum will continue to provide a forum for community-based researchers to network, share challenges, and develop initiatives that provide solutions and facilitate the conduct of clinical trials.

scholarly journals A framework for entry: PAR values and engagement strategies in community research

2010 ◽  
Vol 3 ◽  
pp. 1-19 ◽  
Author(s):  
Joanna Ochocka ◽  
Elin Moorlag ◽  
Rich Janzen
Keyword(s):  
Action Research ◽  
Participatory Action Research ◽  
Research Study ◽  
Community Research ◽  
Participatory Action ◽  
Community Based ◽  
Community Based Research ◽  
Engagement Strategies ◽  
Sensitive Topics ◽  
Collaborative Community

The purpose of this article is twofold: to explore the entry process in community-based research when researching sensitive topics; and to suggest a framework for entry that utilises the values of participatory action research (PAR). The article draws on a collaborative community-university research study that took place in the Waterloo and Toronto regions of Ontario, Canada, from 2005–2010. The article emphasises that community entry is not only about recruitment strategies for research participants or research access to community but it is also concerned with the ongoing engagement with communities during various stages of the research study. The indicator of success is a well established and trusted community-researcher relationship. This article first examines this broader understanding of entry, then looks at how community research entry can be shaped by an illustrative framework, or guide, that uses a combination of participatory action research (PAR) values and engagement strategies. Key words: research entry, community engagement, participatory action research, mental health and cultural diversity

Challenges in Opening and Enrolling Patients in Clinical Trials

2017 ◽  
pp. 139-143
Author(s):  
Julie M. Vose ◽  
Meredith K. Chuk ◽  
Francis Giles
Keyword(s):  
Clinical Trials ◽  
Scientific Integrity ◽  
Cancer Therapies ◽  
Regulatory Requirements ◽  
Cancer Treatments ◽  
Contract Research ◽  
Trial Conduct ◽  
Slowing Down ◽  
Research Organizations ◽  
Trial Participants

Clinical trials are key elements of the processes that account for many of the recent advances in cancer care, including decreased mortality rates and increased survivorship; better supportive care; and improved understanding of cancer risk, prevention, and screening. This research also has led to the validation of numerous exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Clinical trials, however, are becoming more and more challenging to conduct. Research programs must comply with legal and regulatory requirements that can be inefficient and costly to implement and often are variably interpreted by institutions and sponsors and sponsors’ representatives, including contract research organizations. Some of these requirements are essential to protect the safety of trial participants, to promote the scientific integrity of research, or to ensure that trial conduct is efficient and adequately resourced. Such requirements are important to preserve. However, some requirements do not fulfill any of these goals and, in fact, hinder research and slow patient access to safe and effective treatments. This article discusses some of the identified issues that are slowing the process of cancer clinical trials, such as conservatively interpreted guidelines by pharmaceutical companies and contract research organizations; overprotective language for contracts; and patient protections by health systems and universities. The article also discusses possible solutions to these problems that are slowing down the cancer therapies that patients need.

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 Caught up in power: Exploring discursive frictions in community research

2016 ◽  
Vol 9 (1) ◽  
Author(s):  
Cindy Hanson ◽  
Adeyemi Ogunade
Keyword(s):  
Research Process ◽  
Community Research ◽  
Power Dynamics ◽  
Power Relationships ◽  
Community Members ◽  
Community Based ◽  
Community Based Research ◽  
Research Outcomes ◽  
Power Asymmetries ◽  
Research Relationships

This article outlines the debate around the emancipatory claims of community-based research (CBR) and identifies discursive frictions as a pivotal point upon which much of CBR practice revolves. Using a Foucauldian theoretical lens, we suggest that CBR is neither inherently emancipatory nor repressive, but that research outcomes are more often a product of power asymmetries in CBR relationships. To illustrate how power asymmetries in research relationships produce discursive frictions, several studies from our work and the literature are presented. The article provides examples of CBR relationships between the researcher and community members and relationships within the community to illustrate how power asymmetries and discursive frictions in these relationships dynamically influence research outcomes and thus alert researchers to the need to address power asymmetries not just before initiating CBR projects, but during CBR projects as well. We interrogate how power asymmetries and discursive frictions operate and are constructed in CBR in an attempt to highlight how research might be conducted more effectively and ethically. Finally, we indicate that some of the tensions and challenges associated with CBR might be ameliorated by the use of participatory facilitation methodologies, such as photo-voice and story circle discussion groups, that draw attention to power asymmetries and purposefully use more creative participatory tools to restructure power relationships and ultimately address the inequities that exist in the research process. Because CBR is continually caught up in power dynamics, we hope that highlighting some examples might offer an opportunity for increased dialogue and critical reflection on its claims of empowerment and emancipation.Keywords: discursive friction, Foucault, participatory methodologies, power asymmetries, research relationships, emancipatory research  

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