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PubMed2000

Biomedical publication for neurosurgery residents: a program and guide.

One of the most pressing obligations in academic neurosurgery is the publication of clinical and basic science research results. Publication documents intellectual property and communicates findings among researchers working to improve neurosurgical treatment. It documents productivity, justifies funding for research, creates reputations, and builds careers. Nonetheless, the actual writing of reports is a skill often learned by osmosis in academic medicine. To give residents the tools necessary to negotiate the biomedical publication process successfully, we developed a publications program based on the premise that residents seeking an academic career must be prepared to generate publishable reports with maximum efficiency. The program consists of a "publication kit," a series of seminars, and one-on-one tutorials with academic biomedical editors that permit residents individually to improve the quality of their reporting. We describe this program, provide guidelines that can help residents write high-quality papers and publish their work more efficiently, and summarize important content regarding the framework for a successful paper, the elements of a conventional research report, brief guidelines for specific types of papers, reporting standards for clinical trials and meta-analyses, keys to citation in bibliographic indexes, and ethical and legal considerations related to research approval, confidentiality requirements, copyright law, permission to use previously published material, and conflict of interest. Residents who are able to view their work with a sharp critical focus and are educated about the standards of biomedical publication are better prepared to succeed in building a career in academic medicine.

Curriculum↗
PubMedDate not supplied

Opportunities and challenges for clinical and cardiovascular research in Latin America.

Latin America in the past two decades has increasingly become a significant contributor of clinical research. The future capacity of clinical and specifically cardiovascular research has the potential to positively affect human health in the region and foster economic growth. However, the challenges of conducting clinical research in Latin America include a need for logistical support from local governments, continued commitment to education of physicians and ethics committees, and creation of oversight bodies to guarantee the highest quality of research. Bibliometric analyses were conducted to assess trends in clinical research. Latin American investigators demonstrated a tendency to publish clinical results in local and regional journals. The region offers many opportunities for clinical research including large treatment-naive patient populations and most importantly motivated investigators capable of producing high-quality results. Strategies to foster clinical research in Latin America must be based on development of a positive regulatory environment, leveraged protection of intellectual property, creation of alliances between private and public sectors with incentives for investment in science and technology, and finally focus on areas of clinical expertise such as cardiovascular disease, epidemiology, gastroenterology, and infectious diseases. Fostering the creation of research alliances across and between continents will help in establishing the supportive environment for dissemination of important ethical clinical research in the region.

Cardiovascular Diseases↗
PubMedDate not supplied

The status of failure and reliability testing of artificial blood pumps.

Artificial blood pumps are today's most promising bridge-to-transplant, bridge-to-recovery, and destination therapy solutions for patients with congestive heart failure. There is a critical need for increased reliability and safety as the next generation of artificial blood pumps approach final development for long-term destination therapy. To date, extensive failure and reliability studies of these devices are considered intellectual property and thus remain unpublished. Presently, the Novacor N100PC, Thoratec VAD, and HeartMate LVAS (IP and XVE) comprise the only four artificial blood pumps commercially available for the treatment of congestive heart failure in the United States. The CardioWest TAH recently received premarket approval from the US Food and Drug Administration. With investigational device exemptions, the AB-180, AbioCor, LionHeart, DeBakey, and Flowmaker are approved for clinical testing. Other blood pumps, such as the American BioMed-Baylor TAH, CorAide, Cleveland Clinic-Nimbus TAH, HeartMate III, Hemadyne, and MagScrew TAH are currently in various stages of mock loop and animal testing, as indicated in published literature. This article extensively reviews in vitro testing, in vivo testing, and the early clinical testing of artificial blood pumps in the United States, as it relates to failure and reliability. This detailed literature review has not been published before and provides a thorough documentation of available data and testing procedures regarding failure and reliability of these various pumps.

Clinical Trials as Topic↗
PubMed2005

Information assimilation and distribution challenges and goals for real and virtual journals.

The distribution of biomedical information was transfigured over three centuries ago with the introduction of scientific journals. This enabled the widespread dissemination of data to global audiences and greatly facilitated not only the advance of science but amplified the interaction between investigators despite their different locations. This process continued to expand in a linear fashion prior to the emergence of the Internet. The latter system has prompted a phenomenal augmentation of information accessibility, and its ever-expanding use has resulted in an exponential increase in the demand for digital technology and online resources. This technology has achieved unprecedented acceptance in the scientific domain and enabled publishers to expeditiously produce and distribute journal contents online. Such unparalleled access to information has sparked incendiary debate within the scientific community and among journal publishers in regard to numerous issues. It is thus much debated as to who has the right to "own" or control intellectual property, whether information should be made freely available to the online global community, how to gauge the legitimacy and authenticity of published research, and the need to reexamine the feasibility and profitability of paper journals in consideration of the digital, online formats that continue to gain popularity. To assess the current status of the situation, a meeting of journal editors, research scientists, and publishing executives was held in Constance, Germany, on June 26, 2004, to discuss these issues and formulate strategies and recommendations for the future of biomedical publishing. Herewith we provide a summation (manifesto) of the meeting's proceedings and provide a consensus opinion with the aim of illuminating the subject and also proposing some putative solutions for the major challenges that currently confront the scientific and publishing community.

Forecasting↗
PubMed2005

A programmable microsystem using system-on-chip for real-time biotelemetry.

A telemetry microsystem, including multiple sensors, integrated instrumentation and a wireless interface has been implemented. We have employed a methodology akin to that for System-on-Chip microelectronics to design an integrated circuit instrument containing several "intellectual property" blocks that will enable convenient reuse of modules in future projects. The present system was optimized for low-power and included mixed-signal sensor circuits, a programmable digital system, a feedback clock control loop and RF circuits integrated on a 5 mm x 5 mm silicon chip using a 0.6 microm, 3.3 V CMOS process. Undesirable signal coupling between circuit components has been investigated and current injection into sensitive instrumentation nodes was minimized by careful floor-planning. The chip, the sensors, a magnetic induction-based transmitter and two silver oxide cells were packaged into a 36 mm x 12 mm capsule format. A base station was built in order to retrieve the data from the microsystem in real-time. The base station was designed to be adaptive and timing tolerant since the microsystem design was simplified to reduce power consumption and size. The telemetry system was found to have a packet error rate of 10(-3) using an asynchronous simplex link. Trials in animal carcasses were carried out to show that the transmitter was as effective as a conventional RF device whilst consuming less power.

Computer Systems↗
PubMed2005

The next 15 years: taking plant-made vaccines beyond proof of concept.

Significant potential advantages are associated with the production of vaccines in transgenic plants; however, no commercial product has emerged. An analysis of the strengths, weaknesses, opportunities and threats for plant-made vaccine technology is provided. The use of this technology for human vaccines will require significant investment and developmental efforts that cannot be supported entirely by the academic sector and is not currently supported financially by industry. A focus on downstream aspects to define potential products, conduct of additional basic clinical testing, and the incorporation of multidisciplinary strategic planning would accelerate the potential for commercialization in this field. Estimates of production cost per dose and volume of production are highly variable for a model vaccine produced in transgenic tomato, and can be influenced by the optimization of many factors. Commercialization of plant-made vaccine technology is likely to be led by the agricultural biotechnology sector rather than the pharmaceutical sector due to the disruptive nature of the technology and the complex intellectual property landscape. The next major milestones will be conduct of a phase II human clinical trial and demonstration of protection in humans. The achievement of these milestones would be accelerated by further basic investigation into mucosal immunity, the codevelopment of oral adjuvants, and the integration of quality control standards and good manufacturing practices for the production of preclinical and clinical batch materials.

Biotechnology↗
PubMed2006

North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis.

Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.

Biodiversity↗
PubMed2005

Administrative and research policies required to bring cellular therapies from the research laboratory to the patient's bedside.

The research process is a balance between the inherent risks of new discoveries and the risks of research participant safety. Conflicts of interest, inherent to the research process, as well as those introduced by emerging cellular therapies, have the potential to compromise safety. The relationship of trust between the researcher and the clinical trial participant facilitates objective decision making, in the best interest of both parties. In the setup of each clinical trial, investigators incorporate ethical, political, legal, financial, and regulatory considerations as protocols are established. Responsibility to abide by these decisions ensures a systematic process and safeguards participants in this process. The integrity of the research process is strengthened by identifying potential conflicting issues with the guiding principles established in the protocols, which may threaten the objectivity of involved parties and jeopardize safety of the participants. The rapid pace and changing paradigms of new discoveries in cellular therapies exaggerate existing conflicts and introduce new ones. Ethical issues raised by emerging cellular therapies include the division of opinions regarding the use of embryonic and fetal tissue to develop stem cell lines for research, the individual versus professional conscience of a researcher, overselling of outcomes as a result of the researcher's desire to be the first to discover a cellular therapy, and therapeutic misconception resulting from a participant's desire for a miracle cure. The basic ethical issue of whether stem cells should be utilized as a cellular therapy raises heated debates because some believe that it is not acceptable to use fetal material as a source of research material for future cures and others feel equally as strong that inaction is unethical because it results in needless suffering and death owing to the absence of this research. Political issues include the divergent position statements of presidential administrations on cellular therapy, variations in individual state laws, and states becoming involved in research funding, such as California's Proposition 71. Legal concerns include expanding private litigation with diversity of lawsuits, expanding lists of defendants, and the use of class-action lawsuits in research cases. Ownership issues also arise in terms of intellectual property, patents, and ownership of stem cells collected from minors, as in umbilical cord blood donations. Situations that challenge the regulatory processes established to ensure participant safety include differences in reporting requirements for private- and public-funded research and the lack of adequate funding and resources to implement and support the institutional review board (IRB) process. Financial considerations influence the development of clinical protocols, because funding is often limited. Financial incentives, personal investment in companies funding research activities, and fundraising pressures may present potential conflicts. In addition, the increasing role of emerging biotechnology start-up companies and pharmaceutical companies in clinical research introduces additional financial considerations. Administrative policies are needed to address these possible conflicts and ensure research participant safety as cellular therapies progress from the research laboratories to the patient's bedside. Administrative policies to ensure minimum standards of quality for emerging products before human clinical trials, policies to enforce consistent reporting requirements for private and public cellular research, policies to minimize financial conflicts of interest, policies to strengthen implementation of the existing IRB process and to structure into the process a consistent, systematic review of these identified conflicts, and policies to limit private litigation will help to preserve the objectivity of the review process and ultimately increase participant safety.

Cell- and Tissue-Based Therapy↗
PubMed2002

Revisioning nursing scholarship.

PURPOSE: To propose a universal model of nursing scholarship that (a) indicates the importance of professional practice disciplines, (b) incorporates the synthesis of intellectual pursuit with social change, and (c) is holistic in its design. ORGANIZING CONSTRUCT: Scholarship, traditionally viewed as part of or generated in the university enterprise, must be an expectation in all settings in which a community of scholars from both discipline and practice can and do coexist. METHODS: Review and synthesis of the literature on scholarship, nursing scholarship, nursing as a practice discipline. FINDINGS: The history, culture, and intellectual property of nursing comprise an appropriate basis for adopting a universal holistic model of scholarship built upon a set of universal assumptions about nursing scholarship. As a discipline and a profession, nursing should include four connected domains in a universal holistic model of scholarship: knowing, teaching, practice, and service. CONCLUSIONS: Confirmation of this universal holistic model of scholarship can contribute significantly to a larger nursing identity. Use of universal holistic model of nursing scholarship indicates responsibility of the nursing profession collectively and all nurses individually. Additional work is needed to understand how a universal holistic model of nursing scholarship evolves across cultures, domains, and work settings.

Humans↗
PubMed2001

The Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute: industry collaborations in new agent development.

The mission of the Cancer Therapy Evaluation Program (CTEP), a clinical research program of the National Cancer Institute (NCI), is to reduce the burden of cancer. CTEP plans, reviews, and coordinates clinical trials for investigational anticancer agents, from the inception of protocols through the preparation and submission of Investigational New Drug Applications (INDs) to the Food and Drug Administration (FDA). CTEP also serves as a liaison to the FDA for the extramural clinical research community and industry collaborators. Other CTEP functions include managing, tracking, and reviewing clinical protocols as well as monitoring, planning, and maintaining regulatory compliance of the clinical trials. In addition, CTEP coordinates the distribution of the investigational agents from industry collaborators for use in all NCI-sponsored clinical trials. The advantages of collaborating with CTEP are described as well as details about the contractual framework, either a Clinical Trials Agreement (CTA) or a Cooperative Research and Development Agreement (CRADA), for such a collaboration. Many of the concerns raised by industry collaborators with respect to intellectual property, data access, and publications are also addressed.

Clinical Trials as Topic↗
PubMedDate not supplied

Self adhesive dressing pouch for the protection of catheters.

This paper is about a new model of dressing, used for the protection of all types of temporary and permanent catheters. Those who developed this dressing realised the practical difficulties during the placement and removal of traditional dressings, used in haemodialysis units. They also realised that it this was unpleasant for the patients, and there was a risk to the catheters when removing the dressings because of the use of scissors and other cutting instruments. This new dressing solves these previously mentioned problems and at the same time contributes to the comfort of the patients. The model has been registered as a standard using model, and therefore it is protected by law and its copyright (Intellectual Property).

Adhesives↗
PubMed2026

Powering Genome Editing in Rice by Harnessing Promising Gene Resources: A Comprehensive Roadmap.

The imprecise breeding methods including recombination breeding, physical/chemical mutagenesis, and marker-assisted breeding have been extensively utilized for trait improvement of rice crop. Despite tremendous progress made through these breeding methods, the critical issues, such as linkage drag, unintended phenotype, and longer duration of time required to breed a cultivar, have been the major limitations. Among the new breeding technologies, genome editing (GE) has become the most promising approach because of its specificity, precision, and speed. Despite its transformative potential, genome editing continues to face several limitations in crop improvement. These include well-recognized policy challenges, such as biosafety regulations and intellectual property constraints, alongside technical barriers like inefficient tissue culture and transformation systems. Additionally, researchers remain constrained by the limited availability of precise gene information necessary for accurate targeted editing and effective trait enhancement. This review presents an analysis of genes that regulate abiotic and biotic stresses, yield, grain quality and nutrition, plant architecture, nutrient absorption and use efficiency, and other agronomically important traits of rice. The trait-wise probable target genes for genome editing have been discussed in detail. This review will serve as a ready reckoner for rice researchers and funding agencies.

Oryza↗
PubMed2003

Chemosensitization of Plasmodium falciparum by probenecid in vitro.

Resistance to drugs can result from changes in drug transport, and this resistance can sometimes be overcome by a second drug that modifies the transport mechanisms of the cell. This strategy has been exploited to partly reverse resistance to chloroquine in Plasmodium falciparum. Studies with human tumor cells have shown that probenecid can reverse resistance to the antifolate methotrexate, but the potential for reversal of antifolate resistance has not been studied in P. falciparum. In the present study we tested the ability of probenecid to reverse antifolate resistance in P. falciparum in vitro. Probenecid, at concentrations that had no effect on parasite viability alone (50 microM), was shown to increase the sensitivity of a highly resistant parasite isolate to the antifolates pyrimethamine, sulfadoxine, chlorcycloguanil, and dapsone by seven-, five-, three-, and threefold, respectively. The equivalent effects against an antifolate-sensitive isolate were activity enhancements of approximately 3-, 6-, 1.2-, and 19-fold, respectively. Probenecid decreased the level of uptake of radiolabeled folic acid, suggesting a transport-based mechanism linked to folate salvage. When probenecid was tested with chloroquine, it chemosensitized the resistant isolate to chloroquine (i.e., enhanced the activity of chloroquine). This enhancement of activity was associated with increased levels of chloroquine accumulation. In conclusion, we have shown that probenecid can chemosensitize malaria parasites to antifolate compounds via a mechanism linked to reduced folate uptake. Notably, this effect is observed in both folate-sensitive and -resistant parasites. In contrast to the activities of antifolate compounds, the effect of probenecid on chloroquine sensitivity was selective for chloroquine-resistant parasites (patent P407595GB [W. P. Thompson & Co., Liverpool, United Kingdom] has been filed to protect this intellectual property).

Animals↗
PubMedDate not supplied

The federal role in the health information infrastructure: a debate of the pros and cons of government intervention.

Some observers feel that the federal government should play a more active leadership role in educating the medical community and in coordinating and encouraging a more rapid and effective implementation of clinically relevant applications of wide-area networking. Other people argue that the private sector is recognizing the importance of these issues and will, when the market demands it, adopt and enhance the telecommunications systems that are needed to produce effective uses of the National Information Infrastructure (NII) by the healthcare community. This debate identifies five areas for possible government involvement: convening groups for the development of standards; providing funding for research and development; ensuring the equitable distribution of resources, particularly to places and people considered by private enterprise to provide low opportunities for profit; protecting rights of privacy, intellectual property, and security; and overcoming the jurisdictional barriers to cooperation, particularly when states offer conflicting regulations. Arguments against government involvement include the likely emergence of an adequate infrastructure under free market forces, the often stifling effect of regulation, and the need to avoid a common-and-control mentality in an infrastructure that is best promoted collaboratively.

Delivery of Health Care↗
PubMedDate not supplied

Biomedical publishing and the internet: evolution or revolution?

The Internet is challenging traditional publishing patterns. In the biomedical domain, medical journals are providing more and more content online, both free and for a fee. Beyond this, however, a number of commentators believe that traditional notions of copyright and intellectual property ownership are no longer suited to the information age and that ownership of copyright to research reports should be and will be wrested from publishers and returned to authors. In this paper, it is argued that, although the Internet will indeed profoundly affect the distribution of biomedical research results, the biomedical publishing industry is too intertwined with the research establishment and too powerful to fall prey to such a copyright revolution.

Authorship↗
PubMedDate not supplied

Electronic health record meets digital library: a new environment for achieving an old goal.

Linking the electronic health record to the digital library is a Web-era reformulation of the long-standing informatics goal of seamless integration of automated clinical data and relevant knowledge-based information to support informed decisions. The spread of the Internet, the development of the World Wide Web, and converging format standards for electronic health data and digital publications make effective linking increasingly feasible. Some existing systems link electronic health data and knowledge-based information in limited settings or limited ways. Yet many challenging informatics research problems remain to be solved before flexible and seamless linking becomes a reality and before systems become capable of delivering the specific piece of information needed at the time and place a decision must be made. Connecting the electronic health record to the digital library also requires positive resolution of important policy issues, including health data privacy, government encouragement of high-speed communications, electronic intellectual property rights, and standards for health data and for digital libraries. Both the research problems and the policy issues should be important priorities for the field of medical informatics.

Internet↗
PubMed2005

International trade agreements: a threat to tobacco control policy.

International covenants establish a role for governments in ensuring the conditions for human health and wellbeing, which has been recognised as a central human right. International trade agreements, conversely, prioritize the rights of corporations over health and human rights. International trade agreements are threatening existing tobacco control policies and restrict the possibility of implementing new controls. This situation is unrecognised by many tobacco control advocates in signatory nations, especially those in developing countries. Recent agreements on eliminating various trade restrictions, including those on tobacco, have expanded far beyond simply international movement of goods to include internal tobacco distribution regulations and intellectual property rules regulating advertising and labelling. Our analysis shows that to the extent trade agreements protect the tobacco industry, in itself a deadly enterprise, they erode human rights principles and contribute to ill health. The tobacco industry has used trade policy to undermine effective barriers to tobacco importation. Trade negotiations provide an unwarranted opportunity for the tobacco industry to assert its interests without public scrutiny. Trade agreements provide the industry with additional tools to obstruct control policies in both developed and developing countries and at every level. The health community should become involved in reversing these trends, and help promote additional measures to protect public health.

Commerce↗
PubMed1997

PLANT TRANSFORMATION: Problems and Strategies for Practical Application.

Plant transformation is now a core research tool in plant biology and a practical tool for cultivar improvement. There are verified methods for stable introduction of novel genes into the nuclear genomes of over 120 diverse plant species. This review examines the criteria to verify plant transformation; the biological and practical requirements for transformation systems; the integration of tissue culture, gene transfer, selection, and transgene expression strategies to achieve transformation in recalcitrant species; and other constraints to plant transformation including regulatory environment, public perceptions, intellectual property, and economics. Because the costs of screening populations showing diverse genetic changes can far exceed the costs of transformation, it is important to distinguish absolute and useful transformation efficiencies. The major technical challenge facing plant transformation biology is the development of methods and constructs to produce a high proportion of plants showing predictable transgene expression without collateral genetic damage. This will require answers to a series of biological and technical questions, some of which are defined.

Journal Article↗