Currents in Contemporary Ethics: Informed Trust and the Financing of Biomedical Research

2006 ◽  
Vol 34 (2) ◽  
pp. 460-464 ◽  
Author(s):  
Richard R. Sharp ◽  
Mark Yarborough
Keyword(s):  
Clinical Research ◽  
Biomedical Research ◽  
Conflicts Of Interest ◽  
Public Confidence ◽  
Research Collaborations ◽  
Medical Centers ◽  
Medical Institutions ◽  
Academic Medical ◽  
Research Findings ◽  
Research Volunteers

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create.

Use of Informatics and Information Technologies in the Clinical Research Enterprise Within US Academic Medical Centers

2008 ◽  
Vol 56 (5) ◽  
pp. 770-779 ◽  
Author(s):  
Robert DiLaura ◽  
Fran Turisco ◽  
Cherri McGrew ◽  
Stephanie Reel ◽  
John Glaser ◽  
...  
Keyword(s):  
Information Technology ◽  
Information Systems ◽  
Clinical Research ◽  
Biomedical Research ◽  
Information Technologies ◽  
Academic Medical Centers ◽  
Health Care Information ◽  
Medical Centers ◽  
Academic Medical ◽  
Health Care Information Technology

BackgroundData on the state of information systems infrastructures used in the clinical research enterprise of academic medical centers are limited and mostly anecdotal. What has been published is slowly beginning to make important distinctions, such as clinical trials as a specialized form of clinical research and between "Informatics" in an academic setting from health care information technology. However, this field continues to undergo fundamental changes, accelerated by the National Institutes of Health's creation of Clinical and Translational Science Awards to build a new "home" for biomedical research.MethodsWe surveyed all Clinical Research Forum member institutions regarding their enterprise infrastructure and use of information systems in support of clinical research. The questions in this on-line study expanded on one first done in 2005. Of the 52 sites invited, 19 (37%) responded. We analyzed the responses and also made matched comparisons for those organizations that participated in both surveys.ResultsAlthough there continues to be conceptual agreement on information system elements for the clinical research enterprise, no single institution achieved the ideal, a similar result to the 2005 survey. Indeed, little progress was made over the past 2 years at most locations other than in information technology planning, strategy, and governance.ConclusionsThere is increased recognition of the importance of information systems infrastructure and expertise for biomedical research, but the needs are accelerating much faster than institutions can build or pay for. A much greater realization of and innovative solution for this growing chasm is urgently required.

scholarly journals Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

2012 ◽  
Vol 5 (3) ◽  
pp. 281-284 ◽  
Author(s):  
Shawn N. Murphy ◽  
Anil Dubey ◽  
Peter J. Embi ◽  
Paul A. Harris ◽  
Brent G. Richter ◽  
...  
Keyword(s):  
Clinical Research ◽  
Information Technologies ◽  
Academic Medical Centers ◽  
Medical Centers ◽  
Current State ◽  
Academic Medical

Academic Medical Centers and Conflicts of Interest—Reply

JAMA ◽  
2006 ◽  
Vol 295 (24) ◽  
pp. 2845
Author(s):  
Troyen A. Brennan ◽  
David J. Rothman ◽  
Susan Chimonas ◽  
James Naughton ◽  
Jordan Cohen ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Academic Medical Centers ◽  
Medical Centers ◽  
Academic Medical

scholarly journals In Defense of Industry-Physician Relationships

2010 ◽  
Vol 76 (9) ◽  
pp. 987-994 ◽  
Author(s):  
Don K. Nakayama
Keyword(s):  
Conflicts Of Interest ◽  
Professional Organizations ◽  
Medical Innovation ◽  
Medical Centers ◽  
Academic Medical ◽  
Novel Drugs ◽  
Excellent Service ◽  
American College Of Surgeons ◽  
Legal Foundations ◽  
Fiduciary Relationships

The objective was to examine the economic, ethical, and legal foundations for conflict of interest restrictions between physicians and pharmaceutical and medical device industries (“industry”). Recently academic medical centers and professional organizations have adopted policies that restrict permissible interactions between industry and physicians. The motive is to avoid financial conflicts of interest that compromise core values of altruism and fiduciary relationships. Productive relationships between industry and physicians provide novel drugs and devices of immense benefit to society. The issues are opposing views of medical economics, profit motives, medical professionalism, and extent to which interactions should be lawfully restricted. Industry goals are congruent with those of physicians: patient welfare, safety, and running a profitable business. Profits are necessary to develop drugs and devices. Physician collaborators invent products, refine them, and provide feedback and so are appropriately paid. Marketing is necessary to bring approved products to patients. Economic realities limit the extent to which physicians treat their patients altruistically and as fiduciaries. Providing excellent service to patients may be a more realistic standard. Statements from industry and the American College of Surgeons appropriately guide professional behavior. Preservation of industry-physician relationships is vital to maintain medical innovation and progress.

Perceived Institutional Barriers Among Clinical and Research Professionals: Minority Participation in Oncology Clinical Trials

2021 ◽  
Vol 17 (5) ◽  
pp. e666-e675 ◽  
Author(s):  
Soumya J. Niranjan ◽  
Jennifer A. Wenzel ◽  
Michelle Y. Martin ◽  
Mona N. Fouad ◽  
Selwyn M. Vickers ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Community Outreach ◽  
Institutional Factors ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Minority Recruitment ◽  
Institutional Barriers ◽  
Medical Centers ◽  
Academic Medical

PURPOSE: In general, participation rates in cancer clinical trials are very low. However, participation rates are especially low among the socially disadvantaged and racial and ethnic minority groups. These groups have been historically under-represented in cancer clinical trials. Although many patient-related barriers have been studied, institutional factors that are essential for building clinical research infrastructure around the clinical trial enterprise in academic medical centers have been underexplored. MATERIALS AND METHODS: We assessed perspectives of cancer center professional stakeholders on the institutional factors that can potentially influence racial and ethnic minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five US cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Qualitative analyses examined response data focused on institutional factors related to minority recruitment for cancer clinical trials. RESULTS: Four prominent themes emerged regarding institutional barriers among clinical and research professionals. (1) There are no existing programs currently being used to recruit or retain minorities to clinical trials. (2) Institutional efforts are needed to increase trial participation and are not specific to potential minority participants. (3) Access to cancer clinical trials and navigation within an Academic Medical Center need to be simplified to better facilitate recruitment of minority patients. (4) Community outreach by cancer centers will increase clinical research awareness in the community. CONCLUSION: Our research highlights the need to address institutional barriers to improve the success of minority recruitment. To increase participation among minority populations, medical centers must address mutable institutional barriers such as setting specific minority recruitment goals for cancer clinical trials, ensuring that cancer clinical trials are accessible, especially to minority patients, and supporting sustained community outreach programs to increase clinical research awareness.

Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators

2012 ◽  
Vol 40 (3) ◽  
pp. 500-510 ◽  
Author(s):  
Kate Greenwood ◽  
Carl H. Coleman ◽  
Kathleen M. Boozang
Keyword(s):  
Conflicts Of Interest ◽  
The United States ◽  
Private Industry ◽  
High Quality Research ◽  
Advocacy Organizations ◽  
Medical Centers ◽  
Number Of Factors ◽  
Academic Medical ◽  
Financial Interests ◽  
The Government

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation.

Policies of Academic Medical Centers for Disclosing Financial Conflicts of Interest to Potential Research Participants

2006 ◽  
Vol 81 (2) ◽  
pp. 113-118 ◽  
Author(s):  
Kevin P. Weinfurt ◽  
Michaela A. Dinan ◽  
Jennifer S. Allsbrook ◽  
Jo??lle Y. Friedman ◽  
Mark A. Hall ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Academic Medical Centers ◽  
Research Participants ◽  
Medical Centers ◽  
Academic Medical ◽  
Financial Conflicts Of Interest
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