Report 13 of the Council on Scientific Affairs (I-99)
The News Review:
- Report 13 of the Council on Scientific Affairs (I-99)
- Report 3 of the Council on Scientific Affairs (A-01)
- New Independent Research Study Indicates That Cylex’s ImmuKnow…
- SIR Clinpharma to buy research firm in Europe
- Influence of Funding Source on utcome Validity
- Clinical Research Is At Your Fingertips
- New Breakthrough Treatment For Advanced Kidney Cancer Shows 49 Per…
Report 13 of the Council on Scientific Affairs (I-99)
American Medical News – American Medical News (subscription) – Feb 21, 2008
Full Text This report responds to the first resolve of Resolution 309 (I-98) which asks “That our American Medical Association (AMA) report as part of its Clinical Research Summit activities on the need for a national clinical research agenda to establish resource allocation priorities. ” Resolution 309 (I-98) was introduced by the Illinois Delegation and referred to the Board of Trustees. The crisis looming over clinical research has been developing for many years and a number of alarms have been sounded repeatedly. In 1996 the AMA Council on Scientific Affairs convened a major conference on clinical research “Addressing the Future in a Changing Environment” with representation from government academic managed care and other public and private sector perspectives. The focus of the conference a summary report of which was published in the American Journal of Medicine1 was on the future of clinical research and the clinical investigator in an evolving health care system. Issues identified by the conference participants focused on workforce requirements; the movement away from medical specialties and clinical research; a declining number of physician investigators to serve as mentors for younger physicians in training; insufficient protected research time; and the role of increasing student debt in discouraging entry of future clinical investigators… Issues identified by the conference participants focused on workforce requirements; the movement away from medical specialties and clinical research; a declining number of physician investigators to serve as mentors for younger physicians in training; insufficient protected research time; and the role of increasing student debt in discouraging entry of future clinical investigators. Following that conference a mini-symposium on clinical research was conducted at the 1996 meeting of the AMA’s Section on Medical Schools which served as a springboard to Moskowitz and Thompson’s editorial “Preventing the Extinction of the Clinical Research Ecosystem. “2 In response to the challenge articulated in that editorial the AMA the Association of American Medical Colleges (AAMC) and Wake Forest University School of Medicine launched the National Clinical Research Summit project in the fall of 1997 to build a consensus on ways to respond to this crisis by all the stakeholders in clinical research. The tripartite executive committee David Korn MD and Roger Meyer MD from AAMC; Reed V. Tuckson MD Myron Genel MD and Harry Jonas MD from the AMA; and Jay Moskowitz PhD and James Thompson MD from Wake Forest University have guided the project with assistance of David Helms PhD president and CE of the Alpha Center who served as facilitator for the focus groups and the Graylyn Consensus Development conference. In 1998 10 focus groups of stakeholders comprising a total of more than 175 individuals from government and corporate research funding agencies private and public purchasers of health care health plans and insurance companies leaders and representatives of health care communities and academic health centers pharmaceutical and medical device suppliers patient advocacy groups the bioethics communities and others involved in clinical research met to identify the problems facing the clinical research endeavor and potential solutions as perceived from their specific vantage points.
Report 3 of the Council on Scientific Affairs (A-01)
American Medical News – American Medical News (subscription) – Feb 21, 2008
Full Text The Clinical Research Roundtable In response to the report Clinical Research: A National Call to Action and requests from the American Medical Association (AMA) and numerous other sponsoring agencies and organizations the Institute of Medicine (IM) and the Commission on Life Sciences at the National Academies convened a Clinical Research Roundtable (CRR) early in the year 2000. The CRR has brought together individuals from the academic health community federal agencies sponsoring and regulating clinical research private sector sponsors of clinical research foundations public and private sector insurance programs health plans and insurance companies corporate purchasers of health care and representatives of patient interests to discuss the challenges facing clinical research and the approaches that might be followed to create a more supporting environment for a broad agenda of high quality clinical research. Chaired by William Gerberding PhD President Emeritus University of Washington the Roundtable is composed of 28 members and 4 liaisons. Myron Genel MD Past Chair and current Council on Scientific Affairs (CSA) member represents the AMA on the Roundtable. Information on membership and other activities of the CRR is available on its… Background In 1996 the CSA convened a major conference “Clinical Research: Addressing the Future in a Changing Environment. 1 Following a mini-symposium on clinical research conducted at the 1996 meeting of the AMA’s Section on Medical Schools and a subsequent JAMA editorial2 the Clinical Research Summit project comprising more than 175 representatives from government and the private sector was convened by the AMA the Association of American Medical Colleges (AAMC) and Wake Forest University. Participants came from key government agencies the pharmaceutical industry major purchasers of health care health plans and insurance companies patient and family advocates ethicists the broad research community and leaders of academic health centers. The summit was supported by 7 foundations and the project took 18 months to complete. The Summit identified 9 core problems that confront the clinical research enterprise and developed a set of goals that were fully described in the Report of the Graylyn Consensus Development Conference which was issued as a companion to the Summit’s final report Clinical Research: A National Call to Action. ne finding of the Graylyn Report was the lack of a “comprehensive dynamic clinical research agenda” with the Summit recommending that “a visible credible and broadly representative entity should be established to focus continuing national attention on the needs priorities and future progress of clinical research.
New Independent Research Study Indicates That Cylex’s ImmuKnow…
Medical News Today – Feb 21, 2008
announced the publication of an independent peer reviewed clinical research study in which the level of cellular immune response measured prior to kidney transplantation using the Company’s proprietary ImmuKnow(R) immune cell function test was found to identify patients that may be at risk for early acute transplant rejection and unstable kidney function in the first three months following transplantation. The results of this independent clinical research study which was authored by members of the kidney transplant programs at Duke University Medical Center (Durham NC) the University of Minnesota (Minneapolis MN) and Cedars-Sinai Medical Center (Los Angeles CA) appeared in an article published in the February 15 2008 issue of the journal Transplantation. “Based on our immunosuppression protocol this study is the first to show that high pre-transplant ImmuKnow values identify recipients at risk for early acute rejection and unstable renal function” said Dr. Reinsmoen of Cedars-Sinai Medical Center and the lead author of the study. “No other innovative parameter we tested showed any such trends or associations.
SIR Clinpharma to buy research firm in Europe
Daily News & Analysis – Feb 21, 2008
Dr Chetan Tamhankar chief operating officer SIR said “The deal which is in the last stage will be finalised in the next 6-8 weeks but the financials cannot be revealed now. “He did not name the target company either. This move is part of the company’s strategy to create about 7-8 SIR centres in Europe and a similar number in the Asia-Pacific region. “Most of these centres would be set up through acquisitions and we have already done our initial assessments in the Asia-Pacific region” Tamhankar said… It is implementing a new IT framework comprising racle’s life sciences application running on Sun Microsystems’ hardware which will provide a streamlined system for managing large volumes of patient data. SIR plans to spend close to $3 million in the first year to establish the IT framework in its operations. The Indian clinical research industry is expected to be around $2 billion by 2011 and Dr Tamhankar expects clinical study management to grow into a big business vertical in the coming years. The company set up in 1996 offers services in conducting clinical trials in pharmaceutical biotechnology and medical devices sectors and has also set up a clinical research training institute. net #share{clear:both;color:#444;font-size:0.
Influence of Funding Source on utcome Validity
American Medical News – American Medical News (subscription) – Feb 21, 2008
Back to Top Introduction The results (and analysis) of clinical research that are published in peer-reviewed journals inform most treatment decisions and influence public and private health care policy. A longstanding concern exists about the potential for publication bias in pharmaceutical research. Publication bias is the selective publication of studies based on the direction (positive) magnitude and statistical significance of the treatment effect. 4 Studies with positive findings are more likely to be published than studies with negative or null results and an association exists between pharmaceutical industry sponsorship of clinical research and publication of results favoring the sponsor’s products.
Clinical Research Is At Your Fingertips
highbeam.com – Feb 21, 2008
find The Culvert Chronicles articles. (NewsUSA) – The difficult task of finding a suitable clinical trial is about to get easier thanks to the Center for Inf.
New Breakthrough Treatment For Advanced Kidney Cancer Shows 49 Per…
Medical News Today – Feb 21, 2008
” Wyeth Pharmaceuticals Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery development manufacturing and marketing of pharmaceuticals vaccines biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. During this term the Chair will be dedicated to Clinical Research in ncology specifically in kidney cancer with the aim of broadening scientific knowledge to address kidney cancer treatment issues in Canada.
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