Conflict of Interest

Perspectives in Clinical Research, 2015

Conflict of interest in clinical research validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)". [2] Some journals use the term 'competing interest', and the journal Nature defines competing interests as follows: "…those of any kind that could undermine the objectivity, integrity or perceived value of a publication through their potential influence on behavior or content or from perception of such potential influence". [3] Thus, a COI can be differentiated from a competing interest, in that the former affects research as a whole, whereas the latter affects the publication process. A COI occurs in many professions but has serious impact in medical practice and medical research, as a patient's life is often at stake. The mere presence of a COI does not imply an impropriety but suggests the risk of one, and if detected or declared in time, the impropriety can be prevented or at least its impact minimized. In clinical research, the aim of therapeutic studies is to verify the safety and establish the efficacy of new drugs/devices. Though this is the primary aim of the study, the safety and well-being of the participants is more important than the eventual benefit of the drug to the society. As per the

Psychopharmacology, 2003

Rationale: Conflicts of interest in research have long been seen to pose serious threats to the integrity of research. Indeed, the past two decades have revealed increased attention to the possible influence of conflicts of interest as the number of research studies funded by private industry have increased. Objectives: We review empirical findings directly pertinent to issues concerning financial conflicts of interest in biomedical research, and we provide an overview of the current issues and state of understanding concerning such conflicts in research. Methods: We searched Medline from January 1992 to January 2002 to locate current studies that have reported primary or secondary empirical data pertaining to conflicts of interest in research. Results: The rate of potential conflicts of interest for researchers appears to be at least 30% in some situations although the accuracy of such a rate is untested, and the rate of disclosure of conflicts of interest is as low as 2%. Furthermore, some evidence exists to indicate that researchers with conflicting interests may indeed offer different professional opinions and judgments than those for whom such conflicts do not exist. The effectiveness of various disclosure and management methods for conflicts of interest is unknown. Conclusions: We summarize the current empirical literature, concluding that relatively little is known based on such data. We suggest a number of questions that need to be answered by future research, and we offer recommendations for policy makers to consider and evaluate in the future in identifying, revealing, and managing conflicts of interest.

The Permanente journal, 2010

Recently, substantial undisclosed financial Conflicts of Interest (COI) by researchers at academic medical centers have been discovered and reported in US Senate investigations, prompting large research institutions to take a close look at policies and procedures associated with the reporting and with the management of researcher COI. This article defines COI, reviews the background, describes the problems that arise, and offers solutions.

JAMA, 2002

NEW TRENDS IN CLINICAL RESEARCH The interaction between medical research and for-profit corporations is not new, but it has expanded considerably in recent years. Some of the recent trends may accelerate the research process, particularly when large clinical trials are required, but caution is essential. Investment in research and development by the top 20 pharmaceutical companies has more than doubled in the past 7 years. 1 In contrast, revenues are expected to grow only by 7% per annum for the coming years. Therefore, companies will need to generate more than $25 billion in sales to maintain current levels of profitability, which will require industry leaders to launch between 24 and 34 new drugs per year. 1 Furthermore, new drugs will have to cost less to develop or else be sold at higher prices to maintain current profit levels. To achieve this, the pharmaceutical industry will need to pursue more costefficient means of developing products. One way this can be achieved is by turning away from academic health centers , which often are slowed by lengthy review processes and have large overhead expenses. Instead, industry increasingly relies on for-profit intermediary companies to seek less costly venues for the conduct of trials. 2 These organizations-contract research organizations and site management organizations-enable physicians in the private sector to be involved in trials outside academic settings. 3,4 Parallel to the proliferation of these organizations, the overall number of physicians involved in clinical research has increased 600% in 10 years, reaching more than 30000 by 1998. 5 Investigators based in academic medical centers now represent only 46% of those conducting research, a decrease from 80% 10 years ago. 5 Also, only 40% of industry research funding is allocated to clinical trials performed in aca

Annals of health law / Loyola University Chicago, School of Law, Institute for Health Law, 2010

Canadian Medical Association Journal, 1998

A CONFLICT OF INTEREST OCCURS IN A SITUATION in which professional judgement regarding a primary interest, such as research, education or patient care, may be unduly influenced by a secondary interest, such as financial gain or personal prestige. Conflicts of interest exist in every walk of life, including medicine and science. There is nothing inherently unethical in finding oneself in a conflict of interest. Rather, the key questions are whether one recognizes the conflict and how one deals with it. Strategies include disclosing the conflict, establishing a system of review and authorization, and prohibiting the activities that lead to the conflict.

The Journal of Law, Medicine <html_ent glyph="@amp;" ascii="&amp;"/> Ethics, 2006

Journal of medical ethics, 1999

In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest.

Trials, 2011

Background: Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.