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result(s) for
"Conflict of Interest - legislation "
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Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey
by
González-Saldivar, Gerardo
,
Rodríguez-Gutiérrez, René
,
Salcido-Montenegro, Alejandro
in
Adult
,
Aged
,
Awareness
2019
Background
The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics.
Methods
A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial.
Results
A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%,
P
= ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%,
P
= < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%,
P
= 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively).
Conclusion
Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.
Journal Article
The Physician Payments Sunshine Act — Two Years of the Open Payments Program
by
Brown, Douglas
,
Agrawal, Shantanu
in
Access to Information - legislation & jurisprudence
,
Centers for Medicare and Medicaid Services (U.S.)
,
Conflict of Interest - legislation & jurisprudence
2016
Through the Open Payments program (under the Physician Payments Sunshine Act), the Centers for Medicare and Medicaid Services aims to produce more informed consumers, greater understanding of financial relationships in health care, and improved policy development.
The Physician Payments Sunshine Act, part of the Affordable Care Act, requires public reporting of payments made to physicians and teaching hospitals by medical product manufacturers and group purchasing organizations.
1
In the Open Payments program, we at the Centers for Medicare and Medicaid Services (CMS) receive reports from industry on relevant financial interactions and make the information available on a public website. The first round of data, released on September 30, 2014, included financial interactions from August through December 2013. These payments totaled $3.4 billion, from 1347 companies to more than 470,000 physicians and 1019 of the approximately 1200 U.S. . . .
Journal Article
The Sunshine Act — Effects on Physicians
by
Brennan, Niall
,
Agrawal, Shantanu
,
Budetti, Peter
in
Centers for Medicare and Medicaid Services (U.S.)
,
Conflict of Interest - legislation & jurisprudence
,
Disclosure
2013
Under the Physician Payments Sunshine Act, drug and device manufacturers and group purchasing organizations will report to the Centers for Medicare and Medicaid Services payments made to physicians and teaching hospitals, and the data will be posted on a public website.
The new Physician Payments Sunshine Act requires public reporting of payments to physicians and teaching hospitals from pharmaceutical and medical device companies, as well as reporting of certain ownership interests (see box). Sponsored by Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) and supported by consumer advocates, the law covers meals, honoraria, travel expenses, and grants from manufacturers, as well as ownership or investment interests in group purchasing organizations (GPOs), by physicians or members of their immediate family. Information will be posted on a public website that will identify physicians who have received payments or hold ownership. Data collection begins . . .
Journal Article
Achieving greater independence from commercial influence in research
by
Bero, Lisa A
,
Gagnon, Marc-Andre
,
Lexchin, Joel
in
Authorship
,
Bias
,
Biomedical Research - economics
2021
As part of The BMJ’s campaign for greater independence from commercial influence in the creation and use of evidence, Joel Lexchin and colleagues outline some approaches to minimise bias in clinical trials
Journal Article
Beyond Moral Outrage — Weighing the Trade-Offs of COI Regulation
by
Rosenbaum, Lisa
in
Attitude to Health
,
Conflict of Interest - legislation & jurisprudence
,
Conflicts of interest
2015
By casting physician–industry interactions as a moral issue, the conflict-of-interest movement has subverted rational weighing of trade-offs. The resulting \"gotcha quest\" has paradoxically resulted in an erosion of public trust in medicine and science.
Although I probably couldn’t have explained its rationale, I never questioned the anti-pharma animus that pervaded my medical education. The message I received from certain outspoken classmates and fellow trainees was that interacting with pharmaceutical reps was simply wrong. Being caught with a pharma-sponsored sandwich was like being seen throwing compostable items into the garbage: people glared. Being a pharmascold conferred the do-gooder sheen many of us coveted.
I suspect my experience was not unique. Indeed, the American Medical School Student Association (AMSA) now grades medical schools on their creation of a “pharma-free” environment, issuing annual report cards on conflict-of-interest . . .
Journal Article
Why we can’t trust clinical guidelines
by
Lenzer, Jeanne
in
Adrenal Cortex Hormones - administration & dosage
,
Adrenal Cortex Hormones - adverse effects
,
Adrenal Cortex Hormones - economics
2013
Despite repeated calls to prohibit or limit conflicts of interests among authors and sponsors of clinical guidelines, the problem persists. Jeanne Lenzer investigates
Journal Article
Policies on Conflicts of Interest in Health Care Guideline Development: A Cross-Sectional Analysis
by
Faralli, Carla
,
Taruscio, Domenica
,
Morciano, Cristina
in
Accessibility
,
Analysis
,
Clinical medicine
2016
To assess whether organisations that develop health care guidelines have conflict of interest (COI) policies and to review the content of the available COI policies.
Survey and content analysis of COI policies available in English, French, Spanish, and Italian conducted between September 2014 and June 2015. A 24-item data abstraction instrument was created on the basis of guideline development standards.
The survey identified 29 organisations from 19 countries that met the inclusion criteria. From these organisations, 19 policies were eligible for inclusion in the content analysis. Over one-third of the policies (7/19, 37%) did not report or did not clearly report whether disclosure was a prerequisite for membership of the guideline panel. Strategies for the prevention of COI such as divestment were mentioned by only two organisations. Only 21% of policies (4/19) used criteria to determine whether an interest constitutes a COI and to assess the severity of the risk imposed.
The finding that some organisations, in contradiction of widely available standards, still do not have COI policies publicly available is concerning. Also troubling were the findings that some policies did not clearly report critical steps in obtaining, managing and communicating disclosure of relationships of interest. This in addition to the variability encountered in content and accessibility of COI policies may cause confusion and distrust among guideline users. It is in the interest of guideline users and developers to design an agreed-upon, comprehensive, clear, and accessible COI policy.
Journal Article
Transparency and the Doctor–Patient Relationship — Rethinking Conflict-of-Interest Disclosures
by
Adashi, Eli Y
,
Cohen, I. Glenn
,
Elberg, Jacob T
in
and the FDA
,
California
,
Conflict of Interest - legislation & jurisprudence
2022
Transparency and the Doctor–Patient RelationshipTo reduce the harm associated with improper financial relationships between manufacturers and physicians, practitioners could be required to disclose such relationships directly to patients.
Journal Article
Exclusive: US National Science Foundation reveals first details on foreign-influence investigations
2020
The funding agency has taken action in 16–20 cases in which foreign ties were not properly reported.
The funding agency has taken action in 16–20 cases in which foreign ties were not properly reported.
National Science Foundation sign
Journal Article
Conflict of Interest Policies at French Medical Schools: Starting from the Bottom
by
Guy-Coichard, Christian
,
Borde, Jean-Sébastien
,
Outh-Gauer, David
in
Analysis
,
Classrooms
,
Conflict of Interest - legislation & jurisprudence
2017
Medical faculties have a role in ensuring that their students are protected from undue commercial influence during their training, and are educated about professional-industry interactions. In North America, many medical faculties have introduced more stringent conflict of interest (COI) policies during the last decade. We asked whether similar steps had been taken in France. We hypothesized that such policies may have been introduced following a 2009-2010 drug safety scandal (benfluorex, Mediator) in which COIs in medicine received prominent press attention.
We searched the websites of all 37 French Faculties of Medicine in May 2015 for COI policies and curriculum, using standardized keyword searches. We also surveyed all deans of medicine on institutional COI policies and curriculum, based on criteria developed in similar US and Canadian surveys. Personal contacts were also consulted. We calculated a summary score per faculty based on 13 criteria. [range 0-26; higher scores denoting stronger policies].
In total, we found that 9/37 (24%) of French medical schools had either introduced related curriculum or implemented a COI-related policy. Of these, only 1 (2.5%) had restrictive policies for any category. No official COI policies were found at any of the schools. However, at 2 (5%), informal policies were reported. The maximum score per faculty was 5/26, with 28 (76%) scoring 0.
This is the first survey in France to examine COI policies at medical faculties. We found little evidence that protection of medical students from undue commercial influence is a priority, either through institutional policies or education. This is despite national transparency legislation on industry financing of health professionals and limits on gifts. The French National Medical Students Association (ANEMF) has called for more attention to COI in medical education; our results strongly support such a call.
Journal Article