Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited?
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Join the JTF Biannual Global Meeting on June 2, from 9:00 – 11:00 AM ET, to explore the latest advancements in clinical research workforce development and competency-based training. This session will feature global perspectives on implementing the JTF Framework, including:
Results from a Delphi study on data management competencies
Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
How Arizona State University’s Clinical Research Management program integrates the JTF Framework into both its curriculum and accreditation approach
Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
All registrants will receive slides and a meeting summary after the meeting.
Join us on April 3 from 9 – 10 am ET for a webinar dedicated to Global Workforce Development: Tools and Resources, featuring a keynote by Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). Dr. Rago will share insights on CIOMS initiatives to define and synthesize professional competencies essential for clinical research and the need for cooperative agreements to harmonize workforce development efforts.
The session will also highlight the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities of recruiting and retaining a diverse and capable workforce.
Sally Armstrong, CEO of PRAXIS Australia, will share how PRAXIS Australia has used the JTF Framework in their educational offerings, including courses, workshops, and immersive onsite training programs.
Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), will discuss ACRP’s “Partners Advancing the Clinical Research Workforce,” an initiative aimed at building a diverse and qualified clinical research workforce through training programs, educational resources, and collaborations with industry leaders, based on the JTF Framework, to address the needs of the clinical research field by providing pathways for new entrants and career advancement for existing professionals.
This webinar will provide actionable and practical strategies to support global clinical trial professionals.
Key topics:
Utilizing the JTF Framework to define and develop competencies in clinical research
Developing the education and training paradigm for the clinical research workforce
Recruiting and retaining a diverse and representative clinical research workforce
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Research in rare diseases presents several ethical challenges which have to date been under-explored. Decisions about whether to initiate rare disease research in the first place can be complicated by economic realities, given that the eventual market for rare disease therapies may be quite limited. How should companies and research funders generally balance economic and feasibility considerations with the needs of rare patient groups? Other challenges characterize the conduct of rare disease research. Some of these involve issues related to privacy and confidentiality. The smaller the patient population, the easier it may be to identify participants and individuals within clinical trial datasets, even when efforts are made to protect privacy. Others involve how to be fair toward rare disease patients eager to participate in research, which include determining where to run trials and provide fair access. Finally, determining the scope of post-trial obligations toward rare disease populations, and what is owed to rare disease patients who appear to benefit from therapies that lack efficacy in wider populations, can be complicated. How should sponsors and other research stakeholders think about these issues?
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Topic: Medical Need or Market Opportunity: Setting Research Priorities
Abstract: Since funding and other resources for clinical research are limited, decisions must be made about which research projects to pursue, which not to pursue, and how to prioritize among the studies that are chosen. The principle of “unmet medical need” is often acknowledged as a guiding consideration in this context, and there have been calls for community input into prioritization and the choice of the study question. Further, addressing unmet medical needs, particularly in the context of the global burden of disease, is important for public health but may not, and likely will not, maximize market opportunity or financial profits – a dynamic that is particularly salient for private industry sponsors. Should prioritization then rest solely or principally with the funder? How should such entities balance economic obligations toward shareholders with the public good?
One salient principle of distributive justice is “prioritarianism,” the idea that research that stands to benefit the worse-off or those who are already underprivileged should be given priority over research that stands to benefit people in better situations: the well-being of the most disadvantaged is prioritized. Even prior to this, however, questions arise over how to understand the expected goods of research, who the beneficiaries might be, and how the well-being of different possible beneficiary groups should be measured. Further downstream, issues arise over who should engage in prioritization decisions, and in particular, whether the research community should rely solely on high-level, centralized prioritization mechanisms (e.g., industry sponsors, NIH, non-profit funders), or whether individual institutions, local communities, and/or patients and their allies might have some role to play in ensuring that studies are appropriately prioritized at a local level. How should these various voices be heard, should they be represented, and how can—or should—balance be achieved, and if so, what processes should be considered? The March Bioethics Collaborative will seek to address these and other issues in connection with the ethics of research priority-setting.
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
