Advisory Committee Members Research Articles

Conflicts of Interest on Expert Committees: The Case of FDA Drug Advisory Committees

Governments and firms often use committees of experts to help them make complex decisions, but conflicts of interest could bias experts’ recommendations. We focus on whether financial ties to drug companies bias FDA drug advisory committee (AC) members’ voting on drug approval recommendations. We find little significant evidence that AC members vote in their financial interests. We find stronger evidence that experts’ characteristics such as expertise level or associations with advocacy groups drives voting tendencies (biases) either for or against approval. We show that a Congressional Act that effectively excluded financially-conflicted AC members resulted in a sharp drop in average AC member expertise, and an unintended increase in approval voting. Our results have implications for the popular goal of eliminating financial conflicts from all medical decisions. Eliminating conflicts could sharply reduce the level of expertise of the decision makers and lead to unexpected voting tendencies.

Diversity dynamics: The experience of male Robert Wood Johnson Foundation nurse faculty scholars

BackgroundManaging diversity dynamics in academic or clinical settings for men in nursing has unique challenges resulting from their minority status within the profession. PurposeThe purpose of this study was to share challenges and lessons learned identified by male scholars in the Robert Wood Johnson Foundation Nurse Faculty Scholars program and suggest strategies for creating positive organizations promoting inclusive excellence. MethodsMultiple strategies including informal mentored discussions and peer-to-peer dialogue throughout the program, formal online surveys of scholars and National Advisory Committee members, and review of scholar progress reports were analyzed as part of the comprehensive evaluation plan of the program. DiscussionDiversity dynamic issues include concerns with negative stereotyping, microaggression, gender intelligence, and differences in communication and leadership styles. ConclusionMale nurse faculty scholars report experiencing both opportunities and challenges residing in a predominately female profession. This article attempts to raise awareness and suggest strategies to manage diversity dynamics in service of promoting the development of a culture of health that values diversity and inclusive excellence for both men and women in academic, research, and practice contexts.

The role of health economics in the evaluation of surgery and operative technologies

Dr Matthew Taylor is the director of York Health Economics Consortium and leads the Consortium's health technology assessment program. The work of York Health Economics Consortium involves empirical research in health economics for both the private and public sectors. Dr Taylor is the scientific lead for the National Institute for Health and Care Excellence (NICE) Economic and Methodological Unit and a former member of NICE's Public Health Advisory Committee. He is also managing director (Europe) of Minerva, an international network of health economics consultancies.

16th International Conference on Strangeness in Quark Matter (SQM2016)

The Strangeness and Heavy Flavor in Quark Matter in 2016 (SQM2016) conference was held on the beautiful Clark Kerr Campus of the University of California, Berkeley. SQM2016 conference follows a series of conferences with a long tradition of focusing on special topics of strangeness and heavy flavor physics in nuclear collisions. The most recent two conferences in the series were held at Dubna, Russia (SQM2015) and Birmingham, UK (SQM2014).The SQM2016 conference has taken place while heavy-ion research programs at both RHIC and the LHC continue to generate exciting results. The completion of the Heavy Flavor Tracker (HFT) for STAR and the VTX for PHENIX as well as the campaign for heavy quark physics at RHIC have ushered in an exciting era for heavy quark physics at RHIC. The experiments at the LHC - ALICE, ALTAS, CMS and LHCb – continue to advance the energy frontier. We are very pleased and grateful that many experimental and theoretical results were presented at the conference, mostly by young physicists who represent the future of our growing field.We have also used the occasion to dedicate one session for the celebration of scientific achievements made by a pioneer physicist in our community, namely Dr. Grazyna Odyniec. She has made remarkable contributions to measurements of strangeness production and collective motion in nuclear collisions. Moreover, she is also a founding member of the SQM conference series.We would like to thank the International Advisory Committee members for their efforts in shaping the scientific program of the SQM2016 conference. The Local Organizing Committee includes X. Dong (LBNL), H.Z. Huang (UCLA), V. Koch (LBNL), A. Schmah (LBNL), R. Seto (UCR), J. Thäder (LBNL), J. Thomas (LBNL) and N. Xu (LBNL). The conference was hosted by the Nuclear Science Division, Lawrence Berkeley National Laboratory. We gratefully acknowledge Ms. Lady Bonifacio for her service as a conference coordinator. We thank BNL, CCNU, EMMI, HIC for FAIR, LBNL, NWO, ORNL, UCLA and UCR for their sponsorship of the conference.The SQM2017 conference will be hosted by University of Utrecht, Netherlands in July 2017.Huan Zhong Huang (UCLA), Richard Seto (UCR), Jochen Thäder (LBNL) and Nu Xu (LBNL)Editors

Report of the President of the Society for the Advancement of Scandinavian Study

The year 2015 has been a time of change, both in terms of technology and personnel. One of our most important accomplishments of the Society for the Advancement of Scandinavian Study in 2015 was the launching of the new SASS website (designed by Reify Media) (http://scandinavianstudy.org/), Facebook page (https://www.facebook.com/scandinavianstudyorg), and logo. The logo, also designed by Reify Media, has not been as well received as the website. The Executive Council therefore passed a motion to have a new logo designed that will be voted on by the membership. Since the final cost of the website design was significantly below budget, the executive committee agreed to use the remaining funds from the generous grant we received from the Barbro Osher Pro Suecia Foundation to hire a design firm for a new logo. At the same time, we will use this opportunity to redesign the journal. We are pleased to report that our new website has been declared to be mobile-friendly, which, according to Google's new protocols, will cause our website to come in higher in search results. One unfinished part of the website is a repository for syllabi. Mark Sandberg has volunteered to work with this project and will take initial responsibility for receiving, approving, and posting syllabi. Watch for future announcements. Another notable accomplishment was the hiring of our new executive director. Clydette Wantland, with whom we have worked for the past year in her position at University of Illinois Press, has agreed to serve as our first paid executive director. She will help manage the year-to-year financial and organizational tasks of our Society, while vice presidents and presidents, in cooperation with the Executive Council, help provide leadership. Tremendous thanks are due to Richard Jensen, our last volunteer director; he has made the transition as smooth as possible for Clydette. The transition from BYU to the University of Illinois is complete, and has led to efficiencies both with the publication of the journals and handling of memberships. Dues and subscriptions currently cover the publishing costs. It would, however, be desirable to ensure the health and survival of Scandinavian Studies into the future by creating an endowment to pay for publication. Immediate past president Tom DuBois has indicated that such fund-raising will continue to be a priority for him. Thanks also to outgoing advisory committee members John Lindow (history and social sciences) and Julie Allen (language and literature), and welcome to new members Lizette Graden (history and social sciences) and Jonas Wellendorf (language and literature). Warm thanks also go to Susan Brandy (UW-Madison) for her editorship of the Society's journal Scandinavian Studies, to book reviews editor Andrew Nestingen (University ofWashington-Seattle), and also to Louis Janus, newsletter editor. The Society's work could not be carried out without the work of these dedicated volunteers. This year's annual meeting was held at The Ohio State University in Columbus, Ohio, May 6-9, 2015. The presidential theme was Indigenous Discourses, Methodologies, and Histories. …

Practical Analysis and Visualization Tools for Benefit-Risk Assessment in Drug Development: A Review of Recent FDA Advisory Committee Meeting Packages

ABSTRACTWhen providing advice on a medical product, a major task for FDA advisory committee members is to determine whether or not the benefits of the product under discussion outweigh its risks. Thoughtful and creative utilization of analysis methods and visualization tools often helps the sponsors and the FDA to clearly and succinctly deliver the key message, that is, whether the benefit-risk profile is favorable or unfavorable. In this article, we summarize a review of analysis methods and visual tools that were included in recent (during 2011–2014) FDA advisory committee meeting materials. We summarize the key findings related to benefit-risk (B-R) evaluations. Illustrative examples of analysis and visualization tools are provided along with potential refinements to provide readers' proper context for the appropriate use of various B-R tools in practice when evaluating the B-R balance of medical products.

An Online Learning Module to Increase Self-Efficacy and Involvement in Care for Patients With Advanced Lung Cancer: Research Protocol.

BackgroundImproving patient care for individuals with lung cancer is a priority due to the increasing burden of the disease globally. One way this can be done is by improving patient self-management capabilities through increasing their self-efficacy. This can improve positive outcomes for patients with chronic conditions and increase their ability to manage the challenges of such illnesses. Unfortunately, patients with chronic conditions often struggle to travel far from home to engage with patient education events, a common means of improving self-efficacy. The development of more accessible tools for improving patient self-efficacy is required to increase quality of life for patients with chronic conditions.ObjectiveTo evaluate the feasibility of delivering symptom identification and management information to patients with advanced lung cancer using an online program.MethodsThis article describes a pre-post test study to evaluate a Qstream online learning platform to improve patient self-efficacy for managing advanced lung cancer symptoms. Undertaking this program should increase participant knowledge about the side-effects they may experience as a result of their treatment and in turn increase help-seeking behavior and self-efficacy for the participant cohort. Quantitative data collected by the Qstream platform on the completion rates of participants will be used as a tool to evaluate the intervention. Additionally, validated scales will be used to collect data on patient self-efficacy. Qualitative data will also be collected via an exit survey and thematic content analysis of semi-structured interviews.ResultsThe research is in the preliminary stages but thus far a protocol has been approved in support of the project. Additionally, advisory committee members have been identified and initial meetings have been undertaken.ConclusionsDevelopment of new approaches for increasing patient understanding of their care is important to ensure high quality care continues to be delivered in the clinical setting.

To protect everything, please click here: does a revolution in data collection guarantee one in conservation?

An editorial published in Nature (2007) states that “… it can sometimes comes as a surprise for outsiders to learn how far removed the conservation biologist often is from actual efforts to save species”. For conservation biologists who are involved in practical conservation work particularly in countries where the national capacity and infrastructure for conservation is limited, it is clear that it will take more than technology to save the world. We observe an increasing emphasis on technology in the literature and among the research community and ask: How can a revolution in data collection best lead to one in conservation?

Did the IRB Approve This?

Margaret Tempero, MD, is a Professor of Medicine and Director of the UCSF Pancreas Center and editor-in-chief of JNCCN. Her research career has focused on pancreatic ductal adenocarcinoma, especially in the area of investigational therapeutics. Dr. Tempero has served on the ASCO Board of Directors and as ASCO President. She currently serves on the ASCO Conquer Cancer Foundation Board. She codirected the AACR/ASCO Methods in Clinical Cancer Research and taught this course and similar courses in Europe and Australia. She was founding Chair of the NCI Clinical Oncology Study Section and served as a member and Chair of the NCI Board of Scientific Counselors Subcommittee A. She is a member of the Scientific Steering Committee and Chair of the Clinical and Translational Study Section for the Cancer Prevention & Research Institute of Texas. She is or has been on the Scientific Advisory Boards of the Lustgarten Foundation, the Pancreatic Cancer Action Network, the V Foundation, The Alberta Canada Cancer Board, and the EORTC. She served as a member of the Oncology Drug Advisory Committee for the FDA. She has served as Deputy Director and Interim Director for the UNMC Eppley Cancer Center. She is Chief Emeritus of the Division of Medical Oncology at UCSF and served as the founding Deputy Director and Director of Research Programs at the UCSF Helen Diller Family Comprehensive Cancer Center. Did the IRB Approve This?

On the regretful death of Professor/Dr. Shi Ying-Kang.

Former Director of West China (Huaxi) Hospital, Vice President of the Chinese Medical Association, State Council Leading Group for Medical Reform expert advisory committee member, Professor Dr. Shi Ying-Kang passed away in the afternoon of 11 th May 2016. It was reported that Dr. Shi was so disheartened that he jumped down from the twentieth floor of a building. The death of Dr. Shi shocked medical societies in China. People feel sorrowful and mourn his death. As a medical worker in China, I also feel very sad upon this regretful news. Maybe it will offend many people; still hereby I like to express the views which have been held deep in my heart. I hope this article will benefit the health care reform in China.

Philippe Grandjean is the 2015 BCPT Nordic Prize Awardee.

Philippe Grandjean is the 2015 BCPT Nordic Prize Awardee.

Review of the Systolic Blood Pressure Intervention Trial for Hypertension Management: How Low to Go for Patients With Stroke?

One of the great successes of modern medicine is the development of effective pharmacological treatments to lower blood pressure (BP). Of the modifiable risk factors for cardiovascular disease, elevated BP or hypertension has the highest population attributable risk,1 and a near continuous relationship with rates of stroke and coronary heart disease from levels of 115 mm Hg systolic and 75 mm Hg diastolic BP.2 Overviews of randomized trials are consistent in showing that lowering systolic BP by 5 to 10 mm Hg reduces the risk of stroke by one third, irrespective of disease history, initial BP level, or type of agent used.3–5 Moreover, more intensive long-term BP lowering can result in additional benefits proportional to the size of fall in BP.4–6 Despite this body of evidence, there has been longstanding controversy (and consternation) over the levels to which BP should be brought down by treatment for the prevention of cardiovascular disease. Because there has been limited randomized evidence, guideline committees have been challenged in defining BP targets below 130 to 140 mm Hg to manage individual patients.7 Concerns over diminishing net benefit being overtaking by excessive harm with increasing reductions in BP is supported by a physiological argument over critical thresholds for organ perfusion and secondary analysis of randomized trials suggesting a J-shaped relationship with cardiovascular events.8 Moreover, recent trials of more intensive BP lowering, including the Action to Control Cardiovascular Risk on Type 2 Diabetes (ACCORD)9 and Secondary Prevention of Small Subcortical Strokes (SPS3),10 failed to show significant reductions in rates of ischemic stroke with systolic BP reductions below 120 and 130 mm Hg, respectively. The main result of the Systolic …

Heinrich Wänke (1928–2015)

Heinrich Wänke (1928–2015)

Preface

This publication came about after discussions with Derek Raine at the University ofLeicester and staff at LTSN Physical Sciences. Derek was keen to see thedevelopment of a publication that enabled academics in the field to share ideas andgood practice for teaching and learning in the physical sciences.In addition to his research interests as a physicist Derek has a long standing interest in the development of good teaching and learning practice in the physical sciences.Derek is a member of the LTSN Physical Sciences Advisory Committee and recentlywon funding from phase 4 of the Fund for the Development of Teaching and Learning (FDTL). Derek’s project is entitled ‘Project LeAP’ and further information about this work can be found at http://www.le.ac.uk/leap/

Editorial introductions

Editorial introductions

Editorial introductions

Editorial introductions

Guidelines for advisory committees to the board

Advisory committee members, as well as board members, need help in understanding the purpose of an advisory committee. Use the following guidelines to clarify the purpose of your advisory committees.

Effect of foliar application of urea and planofix on the foliage yield of coriander

Note: The authorship was changed on 23.02.2016 FROM Abdur Rakib, M. Kamruzzaman1*, Soyema Khatun1 and M. Moniruzzaman2 TO Abdur Rakib1*, M. Moniruzzaman2, M. Hasan3 and M.M. Rahman3. The authorship is changed due to request of the principal author to add two co-authors of his major professor and advisory committee member of postgraduate study and two co-authors are excluded from the authorship and acknowledged them for their contribution in the manuscript.______________________________________________________________Abstract:An experiment on coriander (Coriandrum sativum L.) was conducted at the experimental field of Department of Horticulture, Bangabandhu Sheikh Mujibur Rahman Agricultural University (BSMRAU), Gazipur during November 2012 to April 2013 to find out the suitable foliar doses and application frequency of urea and planofix (NAA). The experiment was laid out in factorial randomized complete block design with three replications. The treatment consisted of six foliar dozes viz. T1 (Tap water as control), T2 (0.10 % urea), T3 (0.25 % urea), T4 (0.40 % urea), T5 (5 ppm planofix) and T6 (10 ppm planofix) and three application frequencies viz. F1 [20 days after sowing (20 DAS)], F2 (30 DAS) and F3 (20 and 30 DAS). Maximum foliage yield (6.94 t/ha) was recorded in 10 ppm planofix coupled with it’s twice application at 20 and 30 DAS which was closely followed the foliage yield (6.33 t/ha) by 5 ppm planofix with the same application frequency. The foliage yield was increased with the increase in urea concentration. The highest foliage yield (5.37 t/ha) was also recorded from twice application of urea and planofix at 20 and 30 DAS, respectively. Planofix 10 ppm with its twice application at 20 and 30 DAS gave the highest benefit-cost of ration 2.51.Int. J. Agril. Res. Innov. & Tech. 5 (1): 40-44, June, 2015

Association between Oncologic Drugs Advisory Committee (ODAC) members’ financial conflicts of interest (FCOIs) and recommendations for drug approval by the U.S. Food and Drug Administration (FDA).

6582 Background: FDA advisory committees influence decisions relating to the regulatory approval of drugs in the United States. Little is known about whether ODAC members’ FCOIs affect the FDA’s on...

Integrating emerging areas of nursing science into PhD programs

The Council for the Advancement of Nursing Science aims to “facilitate and recognize life-long nursing science career development” as an important part of its mission. In light of fast-paced advances in science and technology that are inspiring new questions and methods of investigation in the health sciences, the Council for the Advancement of Nursing Science convened the Idea Festival for Nursing Science Education and appointed the Idea Festival Advisory Committee to stimulate dialogue about linking PhD education with a renewed vision for preparation of the next generation of nursing scientists. Building on the 2010 American Association of Colleges of Nursing Position Statement “The Research-Focused Doctoral Program in Nursing: Pathways to Excellence,” Idea Festival Advisory Committee members focused on emerging areas of science and technology that impact the ability of research-focused doctoral programs to prepare graduates for competitive and sustained programs of nursing research using scientific advances in emerging areas of science and technology. The purpose of this article is to describe the educational and scientific contexts for the Idea Festival, which will serve as the foundation for recommendations for incorporating emerging areas of science and technology into research-focused doctoral programs in nursing.