Conflict of Interest Disclosure in Oncology: Preliminary Insights From the Global ONCOTRUST-1 Cross-Sectional Study.

PURPOSE: Conflicts of interest (COIs) between oncologists and industry might considerably influence how the presentation of the research results is delivered, ultimately affecting clinical decisions and policy-making. Although there are many regulations on reporting COI in high-income countries (HICs), little is known about their reporting in low- and middle-income countries (LMICs). Oncology Transparency Under Scrutiny and Tracking (ONCOTRUST-1) is a pilot global survey to explore the knowledge and perceptions of oncologists regarding COI. MATERIALS AND METHODS: We designed an online 27-question-based survey in the English language to explore the perceptions and knowledge of oncologists regarding COI, with an emphasis on LMICs. Descriptive statistics and the Consensus-Based Checklist for Reporting of Survey Studies guidelines were used to report the findings. RESULTS: ONCOTRUST-1 surveyed 200 oncologists, 70.9% of them practicing in LMICs. Median age of the respondents was 36 (range, 26-84) years; 47.5% of them were women. Of the respondents, 40.5% reported weekly visits by pharmaceutical representatives to their institutions. Regarding oncologists' perceptions of COI that require disclosure, direct financial benefits, such as honoraria, ranked highest (58.5%), followed by gifts from pharmaceutical representatives (50%) and travel grants for attending conferences (44.5%). By contrast, personal or institutional research funding, sample drugs, consulting or advisory board, expert testimony, and food and beverage funded by pharmaceutical industry were less frequently considered as COI. Moreover, only 24% of surveyed oncologists could correctly categorize all situations representing a COI. CONCLUSION: These findings underscore the importance of clear guidelines, education, and transparency in reporting COI in oncology. This hypothesis-generating pilot survey provided the rationale for ONCOTRUST-2 study, which will compare perceptions of COI among oncologists in LMICs and HICs.

Evolving Landscape of Ethics in Oncology: A Journey Through the Past, Present, and Future.

Providing a brief overview of past, present, and future ethics issues in oncology, this article begins with historical contexts, including the paternalistic approach to cancer care. It delves into present-day challenges such as navigating cancer treatment during pregnancy and addressing health care disparities faced by LGBTQ+ individuals. It also explores the ethical implications of emerging technologies, notably artificial intelligence and Big Data, in clinical decision making and medical education.

Reminder in scarlet: balancing empathy and detachment in oncology.

This article explores an oncologist's journey from emotional vulnerability to practised detachment. A transformative moment, prompted by a poignant photograph of a patient in a scarlet saree, confronts the author with the emotional intricacies of patient care. The narrative delves into the human stories woven into the medical landscape, capturing the delicate balance between clinical detachment and maintaining a genuine connection. It prompts reflection on the emotional dynamics within the decision-making fabric of healthcare.

Financial Conflicts of Interest: Payment at the Expense of Patients?

This provocative editorial proposes four steps that can be immediately implemented to reduce the impact of financial conflicts of interest in oncology without stifling collaboration.

The Ethics of Hope-A Moral Imperative for Oncologists.

This Viewpoint suggests that giving patients with terminal cancer unrealistic hope based only on cure is ethically inferior to redirecting patients toward noncurative goals and noncancer-related hope.

An urgent call to raise the bar in oncology.

Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.

Ethical Considerations in Chemotherapy and Vaccines in Cancer Patients in Times of the COVID-19 Pandemic.

The COVID-19 situation is a worldwide health emergency with strong implications in clinical oncology. In this viewpoint, we address two crucial dilemmas from the ethical dimension: (1) Is it ethical to postpone or suspend cancer treatments which offer a statistically significant benefit in quality of life and survival in cancer patients during this time of pandemic?; (2) Should we vaccinate cancer patients against COVID-19 if scientific studies have not included this subgroup of patients? Regarding the first question, the best available evidence applied to the ethical principles of Beauchamp and Childress shows that treatments (such as chemotherapy) with clinical benefit are fair and beneficial. Indeed, the suspension or delay of such treatments should be considered malefic. Regarding the second question, applying the doctrine of double-effect, we show that the potential beneficial effect of vaccines in the population with cancer (or those one that has had cancer) is much higher than the potential adverse effects of these vaccines. In addition, there is no better and less harmful known solution.

The Ethical Imperative of Equity in Oncology: Lessons Learned From 2020 and a Path Forward.

The COVID-19 pandemic and the simultaneous increased focus on structural racism and racial/ethnic disparities across the United States have shed light on glaring inequities in U.S. health care, both in oncology and more generally. In this article, we describe how, through the lens of fundamental ethical principles, an ethical imperative exists for the oncology community to overcome these inequities in cancer care, research, and the oncology workforce. We first explain why this is an ethical imperative, centering the discussion on lessons learned during 2020. We continue by describing ongoing equity-focused efforts by ASCO and other related professional medical organizations. We end with a call to action-all members of the oncology community have an ethical responsibility to take steps to address inequities in their clinical and academic work-and with guidance to practicing oncologists looking to optimize equity in their research and clinical practice.

Does participation in ethics discussions have an impact on ethics decision-making? A cross-sectional study among healthcare professionals in paediatric oncology.

PURPOSE: The overall aim of this study was to describe perceptions of the decision-making process in relation to participation/non-participation in ethics discussions among healthcare professionals in paediatric oncology. METHODS: Healthcare professionals, working at three paediatric units where ethics discussions where performed answered a study-specific questionnaire focusing on perceptions of involvement, influence, responsibility and understanding of ethics decision-making. Statistical analyses included descriptive statistics, non-parametric paired t-tests and correlation tests. RESULTS: Participation in ethics discussions was related to perceptions of greater involvement and the possibility of influencing decisions, as well as formal/shared responsibility for the ethics decisions related to patient care. Medical doctors and registered nurses perception of involvement in decisions, possibility to influence and responsibility decreased when they were not present during the ethics discussion or when no ethics discussion was conducted at all. Healthcare professionals had a generally good understanding of the ethical issues and the ethics decisions. The whole group considered medical doctors to be the most important participants in the ethics discussions, followed by patients/family. Healthcare professionals wanted more teamwork and viewed ethics discussions as very helpful for teamwork when dealing with ethical issues in paediatric oncology. CONCLUSIONS: Ethics discussions in paediatric oncology practice increases the involvement within and the understanding of the decision-making process about ethical decisions. The understanding is not always dependent on participation, indicating a great trust in team members. Based on these findings the implementation of a structure for ethics support in paediatric oncology where patients/families are integrated is recommended.

The Importance of Prognostication: Impact of Prognostic Predictions, Disclosures, Awareness, and Acceptance on Patient Outcomes.

OPINION STATEMENT: In the advanced cancer setting, patients, families, and clinicians are often confronted with an uncertain future regarding treatment outcomes and survival. Greater certainty on what to expect can enhance decision-making for many personal and healthcare issues. Although 70-90% of patients with advanced cancer desire open and honest prognostic disclosure, a small proportion do not want to know. Approximately half of patients with advanced cancer have an inaccurate understanding of their illness, which could negatively impact their decision-making. In this review, we use a conceptual framework to highlight 5 key steps along the prognostic continuum, including (1) prognostic formulation, (2) prognostic disclosure, (3) prognostic awareness, (4) prognostic acceptance, and (5) prognosis-based decision-making. We shall summarize the impact of prognostic predictions, disclosure, awareness, and acceptance on various patient and caregiver outcomes, such as hope, trust, anxiety, depression, chemotherapy use, and care planning. Based on where the patient is at along the prognostic continuum, we propose 5 different subgroups (avoidance: "I don't want to know"; discordant, "I never wanted to know"; anxious, "I don't know what's happening"; concerned, "I don't like this"; acceptance, "I know how to plan ahead"). Although prognostication is not necessarily a linear process, recognizing where the patient is at cognitively and emotionally along the prognostic continuum may allow clinicians to provide personalized interventions, such as specialist palliative care and psychology referral, towards personalizing prognostic disclosure, enhancing prognostic awareness, increasing prognostic acceptance, and supporting decision-making and, ultimately, improving patient outcomes.

Ethics of Pharma Clinical Trials in the Era of Precision Oncology.

Pharmaceutical industry clinical trials are ethically problematic: human research subjects are being used as a means to the end of demonstrating statistically significant efficacy of novel anticancer agents to achieve regulatory registration and marketing approval. Randomized controlled trial design is inequitable since control arm patients are denied access to the postulated best treatment. Most pharma studies do not provide clinically meaningful benefit of increased overall survival and enhanced quality of life (QOL) to cohorts and are not reliably generalizable to real-world patients. Precision oncology now enables prospective identification of patients expressing a specific cancer biomarker to determine their particular eligibility for evaluation of efficiency of molecular-targeted treatments. A patient-centered approach, collecting prospective real-world data in large populations, could provide real-world evidence of cost-effective, sustained clinical benefits of survival and QOL, while preserving the ethical beneficent compact between patient and doctor.

Discrepancies between author- and industry-reported disclosures of financial relationships at an annual gynecologic oncology research meeting.

OBJECTIVE: Trillions of dollars pass to physicians from industry-related businesses annually, leading to many opportunities for financial conflicts of interest. The Open Payments Database (OPD) was created to ensure transparency. We describe the industry relationships as reported in the OPD for presenters at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting and evaluate concordance between author disclosures of their financial interests and information provided by the OPD. METHODS: This is an observational, cross-sectional study. Disclosure data were collected from authors with oral and featured abstract presentations in the 2019 SGO annual conference. These disclosures were compared to data available for each author in the 2018 OPD, which included the amount and nature of industry payments. RESULTS: We examined the disclosures of 301 authors who met inclusion criteria. Of 161 authors who had disclosure statements on their presentations,147 reported "no disclosures," and 14 disclosed industry relationships. The remaining 140 did not list any disclosure information. Sixty percent (184/301) of authors had industry relationships in the 2018 OPD, including 173 of 287 (60.3%) of authors who either reported no disclosures or did not have disclosure data available in their presentations. These transactions totaled over 43 million USD from 122 different companies, with most payments (46%) categorized as "Research or Associated Research." Accurate disclosure reporting was associated with receiving higher payments or research payments, and being a presenting author. CONCLUSIONS: Most authors at the SGO annual conference did not correctly disclose their industry relationships when compared with their entries in the OPD.

Care in the time of coronavirus: Ethical considerations in head and neck oncology.

As COVID-19 continues to challenge the practice of head and neck oncology, clinicians are forced to make new decisions in the setting of the pandemic that impact the safety of their patients, their institutions, and themselves. The difficulty inherent in these decisions is compounded by potentially serious ramifications to the welfare of patients and health-care staff, amid a scarcity of data on which to base informed choices. This paper explores the risks of COVID-19 incurred while striving to uphold the standard of care in head and neck oncology. The ethical problems are assessed from the perspective of the patient with cancer, health-care provider, and other patients within the health-care system. While no single management algorithm for head and neck cancer can be universally implemented, a detailed examination of these issues is necessary to formulate ethically sound treatment strategies.

Ethical framework for head and neck cancer care impacted by COVID-19.

The COVID-19 pandemic has upended head and neck cancer care delivery in ways unforeseen and unprecedented. The impact of these changes parallels other fields in oncology, but is disproportionate due to protective measures and limitations on potentially aerosolizing procedures and related interventions specific to the upper aerodigestive tract. The moral and professional dimensions of providing ethically appropriate and consistent care for our patients in the COVID-19 crisis are considered herein for head and neck oncology providers.