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PubMedDate not supplied

Electronic trial banks: a complementary method for reporting randomized trials.

BACKGROUND: Randomized clinical trial (RCT) results are often difficult to find, interpret, or apply to clinical care. The authors propose that RCTs be reported into electronic knowledge bases-trial banks-in addition to being reported in text. What information should these trial-bank reports contain? METHODS: Using the competency decomposition method, the authors specified the ideal trial-bank contents as the information necessary and sufficient for completing the task of systematic reviewing. RESULTS: They decomposed the systematic reviewing task into four top-level tasks and 62 subtasks. 162 types of trial information were necessary and sufficient for completing these subtasks. These items relate to a trial's design, execution, administration, and results. CONCLUSION: Trial-bank publishing of these 162 items would capture into computer-understandable form all the trial information needed for critically appraising and synthesizing trial results. Decision-support systems that access shared, up-to-date trial banks could help clinicians manage, synthesize, and apply RCT evidence more effectively.

Databases, Factual↗
PubMed2006

Bench-to-bedside review: human subjects research--are more standards needed?

There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine.

Biomedical Research↗
PubMed2005

Who owns the data?

About ten years ago, a group of scientists began to argue that it was unfair to ask other scientists to pay to read the results of research that had been publicly funded.

Biotechnology↗
PubMed2006

Authorship versus "credit" for participation in research: a case study of potential ethical dilemmas created by technical tools used by researchers and claims for authorship by their creators.

The distinction between authorship and other forms of credit for contribution to a publication has been a persisting controversy that has resulted in numerous guidelines outlining the expected contributions of those claiming authorship. While there have been flagrant, well-publicized deviations from widely accepted standards, they are largely outnumbered by cases that are not publicity-worthy, and therefore remain known to only those directly involved with the inappropriate conduct. We discuss the definition and ethical requirements of authorship, offer a case example of the authorship debate created by a technical tool at our institution, and review parallels that support and dispute the authorship claims of our software developers. Ultimately, we conclude that development of a technical tool that enables data collection does not adequately substitute for contributions to study design and manuscript preparation for authorship purposes. Unless the designers of such a technical tool prospectively participate as a part of the project, they would not have an adequate understanding of the publication's genesis to defend it publicly and cannot be listed as authors. Therefore, it is incumbent upon project members to invite tool developers to participate at the beginning of such projects, and for tool developers to contribute to study design and manuscript preparation when they desire authorship listings.

Authorship↗
PubMed2003

Privacy and the secondary use of data for health research: experience in Canada and suggested directions forward.

This paper has three parts. The first part describes developments in the use of personal information for health research in Canada, challenges in responding to new data protection legislation and the work of the Canadian Institutes of Health Research in assisting the research community to adapt to these developments. The second part critiques two aspects of the stakeholder analysis posited in William Lowrance's report: the lack of an analysis of researchers' interests as distinct from those of society at large, and the framing of privacy as an individual interest. I argue for recasting the privacy and research tension as a values conflict between two societal goods and not an individual versus a societal interest, and for explicitly acknowledging researchers' interests as data users. In so doing, there is no clear trump of privacy or research, and greater importance is placed upon the weighing of benefits and risks of individual studies to determine whether the waiving of consent for a particular study or programme of research is justified. The third part makes specific suggestions as to future ways in which data use practices may evolve. I argue the need to engage the public in deliberating the broad parameters under which personal information will be used, as the public collectively has a major stake in this issue and their input provides legitimacy for these uses of information. In addition, given the proliferation of prospectively-developed databases for research purposes, a 'systems' approach for obtaining consent for participation to replace the current study-by-study recruitment of individuals is appropriate.

Academies and Institutes↗
PubMed2002

A public health agenda for traditional, complementary, and alternative medicine.

Traditional medicine (a term used here to denote the indigenous health traditions of the world) and complementary and alternative medicine (T/CAM) have, in the past 10 years, claimed an increasing share of the public's awareness and the agenda of medical researchers. Studies have documented that about half the population of many industrialized countries now use T/CAM, and the proportion is as high as 80% in many developing countries. Most research has focused on clinical and experimental medicine (safety, efficacy, and mechanism of action) and regulatory issues, to the general neglect of public health dimensions. Public health research must consider social, cultural, political, and economic contexts to maximize the contribution of T/CAM to health care systems globally.

Complementary Therapies↗
PubMed2006

Biodiversity as a source of anticancer drugs.

Natural Products have been the most significant source of drugs and drug leads in history. Their dominant role in cancer chemotherapeutics is clear with about 74% of anticancer compounds being either natural products, or natural product-derived. The biodiversity of the world provides a resource of unlimited structural diversity for bioprospecting by international drug discovery programs such as the ICBGs and NCDDGs, the latter focusing exclusively on anticancer compounds. However, many sources of natural products remain largely untapped. Technology is gradually overcoming the traditional difficulties encountered in natural products research by improving access to biodiverse resources, and ensuring the compatibility of samples with high throughput procedures. However, the acquisition of predictive biodiversity remains challenging. Plant and organism species may be selected on the basis of potentially useful phytochemical composition by consulting ethnopharmacological, chemosystematic, and ecological information. On the conservation/political front, the Convention on Biological Diversity (CBD) is allaying the anxiety surrounding the notion of biopiracy, which has defeated many attempts to discover and develop new natural products for human benefit. As it becomes increasingly evident and important, the CBD fosters cooperation and adaptation to new regulations and collaborative research agreements with source countries. Even as the past inadequacies of combinatorial chemistry are being analyzed, the intrinsic value of natural products as a source of drug leads is being increasingly appreciated. Their rich structural and stereochemical characteristics make them valuable as templates for exploring novel molecular diversity with the aim of synthesizing lead generation libraries with greater biological relevance. This will ensure an ample supply of starting materials for screening against the multitude of potentially "druggable" targets uncovered by genomics technologies. Far from being mutually exclusive, biodiversity and genomics should be the driving force of drug discovery in the 21st century.

Animals↗
PubMed2003

Globalization and the pharmaceutical industry revisited.

This survey of the pharmaceutical industry at the beginning of the 21st century updates some of the information provided in Claudio Tarabusi and Graham Vickery's survey, "Globalization in the Pharmaceutical Industry," published in the International Journal of Health Services in 1998, which was largely based on data up to 1993. However, the purpose of the present article differs from that of Tarabusi and Vickery, which covered a wide range of aspects of the industry relevant to globalization but did not explicitly address the question of the extent to which the industry could be described as globalized. After looking at the industry in some detail, the author directly confronts the question of the appropriateness of the use of the term "globalization" for characterizing the directions in which the pharmaceutical industry has been moving.

Commerce↗
PubMed2006

Pharmacogenomic data sample collection and storage: ethical issues and policy approaches.

This perspective report will focus on the ethical, legal and social issues raised by pharmacogenomic research using large population-based databases. Access to databases established or developed at the level of whole populations or communities (e.g., the Estonian Genome Project, the UK Biobank, CARTaGENE, GenomEUtwin, and so on) will become increasingly important in pharmacogenomic research for the purpose of confirming associations between genetic variations and drug-related effects. The capacity of database creators and managers, along with that of researchers, to meet the ethical issues raised by such vast public projects will determine the integration of pharmacogenomics into mainstream clinical practice.

Computer Security↗