The Future of Conflicts of Interest: A Call for Professional Standards

2012 ◽  
Vol 40 (3) ◽  
pp. 441-451 ◽  
Author(s):  
Bernard Lo
Keyword(s):  
Clinical Research ◽  
Practice Guidelines ◽  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
Clinical Care ◽  
Professional Standards ◽  
Research Practice ◽  
The Future ◽  
Federal Laws ◽  
Financial Relationships

Financial relationships between physicians and industry are widespread. Highly publicized financial relationships between physicians and industry raised disturbing questions about the trustworthiness of clinical research, practice guidelines, and clinical care decisions. Recent incidents spurred calls for stricter conflict of interest policies and led to new federal laws and NIH regulations. These stricter policies have evoked praise, concerns, and objections. Because these new federal requirements need to be interpreted and implemented, spirited discussions of conflicts of interest in medicine will continue.

The Business of Clinical Research

2018 ◽  
pp. 417-433
Author(s):  
Lívia Caroline Mariano Compte ◽  
Jorge Leite ◽  
Andre Brunoni ◽  
Felipe Fregni
Keyword(s):  
Clinical Trial ◽  
Intellectual Property ◽  
Clinical Research ◽  
Conflict Of Interest ◽  
Clinical Case ◽  
Conflicts Of Interest

This chapter presents a series of important topics that should be considered and evaluated before conducting a clinical trial in which there is a collaboration between industry and academia. It discusses important topics such as the project budget and sources of funding. Additionally, this chapter highlights the advantages of the academia-industry partnership, potential conflicts of interest, and, in the advent of a conflict of interest, strategies to minimize its effects. Intellectual property, indemnifications, publication, and other specific issues are also presented as key elements in a clinical trial agreement. A clinical case is used to exemplify and discuss the practical aspects of this challenging negotiation.

scholarly journals Conflict of Interest Disclosure in a Top-Tier Portuguese Medical Journal

2017 ◽  
Vol 30 (9) ◽  
pp. 652
Author(s):  
Nuno Moreira Fonseca
Keyword(s):  
Medical Journal ◽  
Pharmaceutical Industry ◽  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
Letters To The Editor ◽  
Clinical Images ◽  
Independent Information ◽  
Financial Relationships

Introduction: Scientific medical publications are considered to be a source of unbiased and independent information. Authors are required to disclose relationships with the pharmaceutical industry for transparency purposes. The aim of this work was to assess conflict of interest disclosure in a Portuguese top-tier medical journal by comparing authors’ self-reported conflicts of interest with payments listed in the official database of Portuguese Ministry of Health.Material and Methods: All articles published in the Portuguese Journal of Cardiology from December 2015 to May 2016 were reviewed. Articles based on clinical images, with authors affiliated to foreign institutions, editorials, letters to the editor, or submitted before January 1st 2015 were excluded. Authors were categorized on concordance between self-reported disclosures and payments listed in the database. Authors who authored multiple articles were counted as new authors, since each paper offered a new opportunity for financial disclosure.Results: Of the 155 authors surveyed, 82 (53%) were in perfect concordance with the sunshine database, while 73 authors (47%) had one or more undisclosed payments. Undisclosed payments totaled over € 210 000. Four (17%) articles mentioned a conflict of interest, 24 articles (96%) had at least one author with undisclosed payments.Discussion: None of the payments listed in the database was acknowledged in self-reported conflicts of interest. This might indicate that authors do not consider their financial relationships with the industry to be relevant.Conclusion: The lack of concordance between self-reported conflicts of interest and payments found in the database raises concerns about incomplete disclosure.

Good Clinical Research Practice guidelines and PK-PD modelling without twitch stabilisation

2008 ◽  
Vol 52 (4) ◽  
pp. 577-578 ◽  
Author(s):  
D. J. Eleveld ◽  
J. H. Proost ◽  
A. De Haes ◽  
J. M. K. H. Wierda
Keyword(s):  
Clinical Research ◽  
Practice Guidelines ◽  
Research Practice

scholarly journals Dissemination of Quality-of-Care Research Findings to Breast Oncology Surgeons

2011 ◽  
Vol 7 (4) ◽  
pp. 257-262 ◽  
Author(s):  
Stacey Shiovitz ◽  
Ashley Gay ◽  
Arden Morris ◽  
John J. Graff ◽  
Steven J. Katz ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Clinical Research ◽  
Clinical Care ◽  
The Internet ◽  
Care Research ◽  
The Future ◽  
Research Findings

The Internet is a useful tool for providing relevant clinical research to providers, but in the future could be tailored to an individual's needs, aiding synthesis and, hopefully, improving the quality of clinical care.

scholarly journals Analysis of conflict of interest policies among organizations producing clinical practice guidelines

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249267
Author(s):  
J. Henry Brems ◽  
Andrea E. Davis ◽  
Ellen Wright Clayton
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
Public Trust ◽  
Institute Of Medicine ◽  
Internet Search ◽  
The Public ◽  
Document Review

Background Conflicts of interest (COI) jeopardize the validity of Clinical Practice Guidelines (CPGs). When the Institute of Medicine promulgated COI policies in 2011, few organizations met these requirements, but it is unknown if organizations have improved their policies since that time. We sought to evaluate current adherence to IOM standards of COI policies. Methods and findings We conducted a retrospective document review of COI policies and CPGs from organizations that published five or more CPGs between January 1, 2018 and December 31, 2019. Organizations were identified via CPG databases. COI policies were obtained from an internet search. We collected data on i) the number of organizations that have COI policies specific to CPG development, ii) the number of policies meeting each IOM standard and iii) the number of IOM standards met by each policy. COI disclosures from five CPGs of each organization were assessed for adherence to IOM standards. Among the 46 organizations that published 5 or more CPGs, 36 (78%) had a COI policy. Standard 2.2b (requiring divestment of financial COI) was met least frequently, by 2 of 36 (6%) organizations. Standard 2.1 (requiring disclosure of COI) was met most frequently, by 33 of 36 (92%) organizations. A total of 31 of 36 (86%) organizations met 4 or fewer of the 7 IOM standards. Among the 16 organizations limiting COI to a minority of the CPG panel (standard 2.4c) and the 15 organizations prohibiting COI among chairs or co-chairs (standard 2.4d), 12 (75%) and 10 (67%) organizations violated the respective standard in at least one CPG. The main limitations of our study are the exclusion of organizations producing fewer CPGs and ability to assess only publicly available policies. Conclusion Among organizations producing CPGs, COI policies frequently do not meet IOM standards, and organizations often violate their own policies. These shortcomings may undermine the public trust in and thus the utility of CPGs. CPG-producing organizations should improve their COI policies and their strategies to manage COI to increase the trustworthiness of CPGs.

General Particulars Regarding the Conflict of Interest

2020 ◽  
Vol 26 (2) ◽  
pp. 145-149
Author(s):  
Aurelia Teodora Drăghici
Keyword(s):  
Local Government ◽  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
National Level ◽  
The State ◽  
Role Of The State ◽  
Legal Implications ◽  
Determining Factors ◽  
Changing Role

SummaryTheme conflicts of interest is one of the major reasons for concern local government, regional and central administrative and criminal legal implications aiming to uphold the integrity and decisions objectively. Also, most obviously, conflicts of interest occur at the national level where political stakes are usually highest, one of the determining factors of this segment being the changing role of the state itself, which creates opportunities for individual gain through its transformations.

Preventing and Managing Conflict of Interest in Nutrition Policy: Lessons for Alcohol Control Comment on "Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool"

2020 ◽  
Author(s):  
Katherine Severi
Keyword(s):  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
Nutrition Policy ◽  
Alcohol Policy ◽  
World Health ◽  
Alcohol Control ◽  
Policy Debates ◽  
Food And Nutrition ◽  
Industry Engagement ◽  
Health Organization

Ralston et al present an analysis of policy actor responses to a draft World Health Organization (WHO) tool to prevent and manage conflicts of interest (COI) in nutrition policy. While the Ralston et al study is focussed explicitly on food and nutrition, the issues and concepts addressed are relevant also to alcohol policy debates and present an important opportunity for shared learning across unhealthy commodity industries in order to protect and improve population health. This commentary addresses the importance of understanding how alcohol policy actors – especially decision-makers – perceive COI in relation to alcohol industry engagement in policy. A better understanding of such perceptions may help to inform the development of guidelines to identify, manage and protect against risks associated with COI in alcohol policy.

scholarly journals Patient Experience in Home Respiratory Therapies: Where We Are and Where to Go

2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  
Keyword(s):  
Clinical Research ◽  
Patient Experience ◽  
Clinical Care ◽  
Research Priorities ◽  
Specific Patient ◽  
Quality Healthcare ◽  
Body Of Knowledge ◽  
Number Of Patients ◽  
Patient Reported ◽  
System Sustainability

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.

scholarly journals Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ciska Verbaanderd ◽  
Ilse Rooman ◽  
Isabelle Huys
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Financial Support ◽  
Social Impact ◽  
Grey Literature ◽  
Economic Incentives ◽  
Phase Iii ◽  
Medical Needs ◽  
The Future ◽  
Funding Mechanisms

Abstract Background Finding new therapeutic uses for existing medicines could lead to safe, affordable and timely new treatment options for patients with high medical needs. However, due to a lack of economic incentives, pharmaceutical developers are rarely interested to invest in research with approved medicines, especially when they are out of basic patent or regulatory protection. Consequently, potential new uses for these medicines are mainly studied in independent clinical trials initiated and led by researchers from academia, research institutes, or collaborative groups. Yet, additional financial support is needed to conduct expensive phase III clinical trials to confirm the results from exploratory research. Methods In this study, scientific and grey literature was searched to identify and evaluate new mechanisms for funding clinical trials with repurposed medicines. Semi-structured interviews were conducted with 16 European stakeholders with expertise in clinical research, funding mechanisms and/or drug repurposing between November 2018 and February 2019 to consider the future perspectives of applying new funding mechanisms. Results Traditional grant funding awarded by government and philanthropic organisations or companies is well known and widely implemented in all research fields. In contrast, only little research has focused on the application potential of newer mechanisms to fund independent clinical research, such as social impact bonds, crowdfunding or public-private partnerships. Interviewees stated that there is a substantial need for additional financial support in health research, especially in areas where there is limited commercial interest. However, the implementation of new funding mechanisms is facing several practical and financial challenges, such as a lack of expertise and guidelines, high transaction costs and difficulties to measure health outcomes. Furthermore, interviewees highlighted the need for increased collaboration and centralisation at a European and international level to make clinical research more efficient and reduce the need for additional funding. Conclusions New funding mechanisms to support clinical research may become more important in the future but the unresolved issues identified in the current study warrant further exploration.

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