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The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop.

At the Washington DC Pharmacogenomics in Drug Development and Regulatory Decision-Making: Workshop III - Three Years of Promise, Proposals and Progress on Optimizing the Benefit/Risk of Medicines (11-13 April 2005), one break-out session (Track 2) focused on co-development of therapeutic drug and diagnostic products. The Food and Drug Administration (FDA) released a draft concept paper shortly before the workshop was to convene. Track 2 was a forum for initial discussion of the content of the concept paper, and industry's initial reactions. After the workshop, formal commentaries on the co-development concept paper were submitted by several trade associations (e.g., Pharmaceutical Research and Manufacturers of America (PhRMA), Advanced Medical Technology Association (AdvaMed), American Association for Clinical Chemistry) and individual companies to FDA's Docket No. 2004N-0279. This paper includes a summary of the key features of the draft concept paper, the discussion in Track 2 of the April, 2005 meeting and highlights of the industry comments submitted to the FDA docket following the meeting.

Clinical Trials as Topic↗

Developing A&E nursing responses to people who deliberately self-harm: the provision and evaluation of a series of reflective workshops.

Accident & Emergency (A&E) departments and Medical Admission Units (MAUs) are an essential part of emergency mental health care in the UK. Deliberate self-harm and attempted suicide are particular challenges to nursing staff in such departments. Two registered mental nurses with experience of education facilitated a series of workshops with nurses from four A&E departments, two Minor Injuries Units and two MAUs. These were focused upon the assessment and management of deliberate self-harm and attempted suicide. During the workshops, participants provided systematic information on presentations of deliberate self-harm and attempted suicide, and on their professional responses to such presentations. These accounts provided invaluable information on deliberate self-harm and attempted suicide as seen by nursing staff in A&E and MAUs. Critical reflection upon nursing responses to these presentations revealed particular concerns nurses had relating to their experience with this client group which might inform future practice. Evaluation of the workshops indicated a subsequent decrease in work-related stress, which was probably a consequence of improved professional coping responses by the nurses concerned.

Adolescent↗

Learning for real life: patient-focused interprofessional workshops offer added value.

OBJECTIVES: This paper reports relevant findings of a pilot interprofessional education (IPE) project in the Schools of Medicine and Healthcare Studies at the University of Leeds. The purpose of the paper is to make a contribution towards answering 2 questions of fundamental importance to the development of IPE. Is there a demonstrable value to learning together? What types of IPE, under what circumstances, produce what type of outcomes? DESIGN: Pre-registration house officers (PRHOs), student nurses and pre-registration pharmacists attended a series of 3 workshops intended to develop participants' understanding about each other's professional roles, to enhance teamworking and to develop communication skills. Evaluation covered the process of development of the workshops, the delivery of the workshops and their effects on both facilitators and participants. RESULTS: The course was well received by the participants. The learning reported by the participants reflected 2 project objectives. Participants emphasised communication skills--both with other professionals and patients--and the development of increased awareness of others' roles. These 2 aspects were interlinked. CONCLUSIONS: The project aims and 2 of the learning outcomes were achieved. There was a demonstrable value to learning together, particularly with regard to interprofessional communications. This project was effective and can make a contribution towards answering the question 'What types of IPE, under what circumstances, produce what type of outcomes?'

Communication↗

Workshop on a detailed characterization of Trichinella spiralis antigens: a platform for future studies on antigens and antibodies to this parasite.

In order to characterize immunodominant components of T. spiralis a workshop was organized. In this the reactivity of monoclonal and polyclonal antibodies, provided by different research groups, towards total extracts from adult, new born larvae and muscle larvae as well as to excretory/secretory components of muscle larvae were tested by ELISA, Western blot and immunoprecipitation assays. As a result of this workshop T. spiralis ML antigens have been classified into eight groups (TSL-1-TSL-8) according to their recognition by monoclonal and polyclonal antibodies. Among them, TSL-1 antigens have been the most extensively characterized both biochemically and immunologically. These antigens are stage specific, originate in the muscle stichosome and are abundant in both E/S and on the larval cuticular surface. The TSL-1 antigens share an immunodominant carbohydrate epitope (tyvelose), which is unique for Trichinella and is not associated with phosphorylcholine. The data collected in this workshop has allowed both the unification of the nomenclature for T. spiralis antigens and their biochemical characterization. It also has provided a platform for further studies on the characterization of other T. spiralis antigens and indeed for other Trichinella species.

Animals↗

Report on the Eleventh International Society of Blood Transfusion Platelet Genotyping and Serology Workshop.

BACKGROUND AND OBJECTIVES: The aims of the Eleventh International Workshop were to evaluate proficiency in platelet genotyping and antibody detection, to equip laboratories to perform Gov antigen system genotyping and antibody detection, and to evaluate the laboratory and clinical approach to cases of neonatal alloimmune thrombocytopenia (NAIT). MATERIALS AND METHODS: There were 34 participating laboratories from 22 countries on five continents. Participating laboratories were provided with 10 DNA samples, 15 unknown sera, and three monoclonal antibodies for titration, as well as primer pairs and a protocol for Gov genotyping and Gov antibody screening. They were also provided with a questionnaire on investigation and clinical management of patients with NAIT. RESULTS: Thirty-three participants reported human platelet antigen (HPA)-1, -2, -3 and -5 genotyping results, 25 reported HPA-4 typing results, 17 reported HPA-6 typing results and 24 reported Gov typing results. For HPA-1-6 genotyping, 23 laboratories were concordant with a majority vote for all allotypes tested, five laboratories reported one deviation, three laboratories reported two deviations and one laboratory reported three deviations. For Gov genotyping, six deviations occurred in three of the 24 laboratories reporting results. Antibody detection was 90% concordant for anti-HPA-1a, anti-HPA-5a and anti-HPA-5b detection. Anti-HPA-2b and anti-Gova were detected by 20 and 14 out of 33 laboratories, respectively. Approaches to the clinical management of NAIT vary widely, especially for mothers with a history of a previous infant with mild NAIT. CONCLUSIONS: The overall error rate for HPA-1-6 genotyping decreased from 2.7% in the tenth workshop to 0.8% in the eleventh workshop. The majority of laboratories were able to perform Gov genotyping, although the error rate was 7.5%. Detection of common clinically significant antibodies was good, although detection of the much rarer HPA-2b was problematic. There was considerable progress in the detection of anti-Gova. The lack of consensus over treatment of NAIT demonstrates uncertainty over optimal management of these patients.

Antigens, Human Platelet↗

Report on the Fifth International Society of Blood Transfusion Platelet Serology Workshop.

The Fifth International Society of Blood Transfusion (ISBT) Platelet Serology Workshop took place in 1990. A total of 21 laboratories participated in the wet workshop. Results were discussed at a meeting of the International Committee on Standardization in Haematology (ICSH) Expert Panel on Platelet Serology at the Joint Congress of the ISBT and the American Association of Blood Banks in Los Angeles in November 1990. Each of the participants analyzed 37 serum samples for platelet-reactive alloantibodies and isoantibodies. In addition, two drug-dependent (quinine) platelet-specific antibodies had to be identified among a subset of seven sera. For the first time in a platelet serology workshop, five platelet suspensions had to be typed for the alloantigens of the HPA-1, -3, -4, and -5 systems.

Antibodies↗

Dietary lipids and vascular function: UK Food Standards Agency workshop report.

The UK Food Standards Agency convened a group of expert scientists to review current research investigating the effect of dietary lipids on vascular function. The workshop highlighted the need for intervention studies to be sufficiently powered for these measures and that they should be corroborated with other, more validated, risk factors for CVD. Work presented at the workshop suggested a beneficial effect of long-chain n-3 PUFA and a detrimental effect of trans fatty acids. The workshop also considered the importance of the choice of study population in dietary intervention studies and that "at risk" subgroups within the general population may be more appropriate than subjects that are unrepresentatively healthy.

Cardiovascular Diseases↗

An 18-month follow-up on the effectiveness of a sexuality workshop: some methodological pitfalls.

Students from four health sciences programs (Medicine, Nursing, Occupational Therapy and Physiotherapy) participated in a two-day Sexuality Workshop and completed pre- and post-workshop questionnaires dealing with sexual attitudes, comfort, and knowledge. Eighteen months later, these students were asked to complete the same questionnaires. Not only had they sustained the gains made during the workshop, but they continued to show improvement in the three areas during this interval. However, of greater importance than the positive finding is the need to understand the range of methodological problems encountered in carrying out this type of follow-up educational inquiry and in seeking measures for improving the validity and generalizability of such research.

Education↗

Medical students' attitudes and behaviour towards sexual health interviewing: short- and long-term evaluation of designated workshops.

Workshops aimed at promoting fourth-year medical students' attitudes towards and subsequent behaviour in talking to patients about sexual health are reported on. Improvements in attitudes are reported following the workshops in 1999-2000 with students being more likely to see the relevance of sexual health enquiry, feeling more confident and competent about broaching the subject and expressing greater intention to do so. One year on, comparison of the intervention and non-intervention group for attendance at the workshop showed no difference in the proportion who had subsequently asked patients questions about sex. The proportion of students asking patients rose from 47% in the fourth year to 92% by the fifth year. Issues of long-term evaluation and the importance of the informal relative to the formal curriculum are discussed.

Attitude of Health Personnel↗

Associative learning and representation. An EPS workshop for N. J. Mackintosh, 9 July 2002.

The papers published in this Special Issue are based upon presentations at a workshop on Associative Learning and Representation, which was sponsored by the Experimental Psychology Society and hosted by Emmanuel College, Cambridge. The workshop celebrated the contribution of Professor Nicholas Mackintosh to animal learning and conditioning in particular and experimental psychology in general in the year of his retirement from the Chair of Psychology at the University of Cambridge after 21 years in post. The date of the workshop, 9 July 2002, was particularly auspicious as it was the day of Professor Mackintoshs birth 67 years ago. Moreover, it is particularly fitting that this tribute is published in the Comparative and Physiological Psychology Section (B) of Quarterly Journal of Experimental Psychology, which he founded in 1981 during his editorship of the Journal between 1977 and 1984.

Animals↗

Genetic aspects of nutrition and toxicology: report of a workshop.

The health and resilience of humans and animals is, in large part, determined by the quality and quantity of the diet. This, in turn, may influence an individual's capability to deal with stress including toxic insult. In addition, there may be specific components of the diet that modulate the toxicity of specific toxicants whether the latter are ingested as food or absorbed via other routes. Many examples attest to the importance of interactions between dietary components and toxicants after absorption in the body. Such interactions occur at every level of biological organization from the molecular to the whole organism. Some may be synergistic, others antagonistic. Some may involve direct chemical reaction between the nutrient molecule and the toxicant, others may occur by indirect action at the cellular or organ levels. All examples point to the importance of considering diet when measuring the response to toxic agents whether in animals or humans. In order to foster interaction between the sciences of nutrition and toxicology, The Heinz Institute of Nutritional Sciences as sponsoring a series of workshops. The first of these was held in June, 1999 at the University of Ulster to address evolutionary aspects of nutrition--toxicology (for report see Eur. J. Nutr, 39, 49-52, 2000). In June, 2000, a second workshop was held at the University of Toronto to address genetic aspects, and this is a brief summary of the proceedings. We are beginning to understand the molecular basis of the regulation of gene expression by dietary factors and how genetic changes can affect response to toxicants. Recent advances in technology and a detailed understanding of disease etiology has led to the ability to study molecular determinants of disease risk. The workshop provided a forum for nutritionists, toxicologists, molecular biologists, epidemiologists and others to discuss common interests and to merge their efforts towards an integrated approach to nutrition--toxicology via genetics and genomics. The first session dealt with the mechanism by which nutrients such as fatty acids (Clarke), amino acids (Jefferson) and metal ions (Cousins) can regulate gene expression. In the second session, there were presentations on the effects of nutritional factors on genes of toxicological significance such as phase I and phase II enzymes of drug metabolism (Guengerich, Goodfellow and Grant) as well as on oxidative DNA damage and its repair (Collins, Weindruch). Session three dealt with gene-nutrient interactions in the development of chronic diseases such as diabetes (Hegele, Berdanier) and cancer (Kim, Ambrosone et al.). New developments such as DNA microarrays (McGlynn) and the use of transgenic and knockout models (Sehayek) were presented in the final session.

Aging↗

Healthy dating: a mixed-gender date rape workshop.

College communities are increasingly being called upon to institute date rape prevention programs. This article describes a mixed-gender workshop sponsored by a university's Program for Rape Education and Prevention that was given to more than 1,400 undergraduate students in more than 80 presentations. In order to guide modifications of the workshop, formative evaluation data collected from 330 male (mean age 20.3 years) and 314 female (mean age 20.5 years) university students were collected. Results were largely positive. Despite the sensitive nature of the topic, only 10.2% of the men and 8.2% of the women reported being uncomfortable discussing date rape in mixed-gender groups. Furthermore, students were virtually unanimous in their agreement that date rape is a topic worthy of a workshop.

Adult↗

Development of a direct education workshop for cervical cancer prevention in high risk women: the Forsyth County project.

With funding from the National Cancer Institute, a public health education program was developed with the primary objective of increasing the proportion of black women in Forsyth County, North Carolina, who receive Pap smears on a regular basis. This paper reports on the development and implementation of the direct education component of the program. The content of the workshop was based on community analysis of current knowledge, attitudes, and behaviors in the target population, and a review of relevant literature on cervical cancer and the Pap smear. Methods for presentation of the content were refined through three pilot tests. Audiovisual materials were also developed to illustrate key points. The direct education component of the program was designed to function as a short workshop and includes an overview of healthy lifestyles, coverage of the importance of early detection of cancer, a description and discussion of the pelvic exam and the Pap smear, and a discussion of common barriers to obtaining Pap smears on a regular basis. Evaluation of the workshop emphasizes process measures, including a questionnaire to collect demographic information and impressions of the presentation. Interim results of the evaluation are discussed.

Adolescent↗

Randomized controlled trial on the effects of a skills-based workshop on medical students' management of problem drinking and alcohol dependence.

The purpose of this study was to determine whether a skills-based workshop will improve medical students' management of problem drinking and alcohol dependence in simulated patients. Seventy-six 3rd and 4th year Ontario medical students were randomized to receive a 3-h workshop on either problem drinking and alcohol dependence or depression (control condition). Students then completed eight simulated office visits (OSCE stations) with simulated patients presenting with depression, problem drinking or alcohol dependence. Examiners completed a checklist of the questions asked and advice given by the student, and simulated patients and examiners completed a global rating scale. Four months later, students were sent a survey on their knowledge, attitudes, and behavior towards patients with alcohol problems. The alcohol group received significantly higher assessment and management checklist scores and global rating scores than did the depression group (p < 0.01) and performed better on almost all aspects of clinical management of both problem drinking and alcohol dependence. On the follow-up survey (n = 55) the alcohol group showed a significant increase in beliefs about self-efficacy in managing alcohol problems (p < 0.05) and had greater knowledge of reduced drinking strategies, but the two groups did not differ on other measures. A skills-based workshop causes marked short-term improvements in medical students' management of problem drinking and alcohol dependence, an increase from baseline to postworkshop in self-efficacy beliefs that was sustained through to follow-up, and greater knowledge of reduced drinking strategies. Repeated reinforcement of clinical skills may be required for a long-term impact on clinical behavior.

Alcohol Drinking↗

Allocation of research funds in the drug and alcohol field: report of the Consensus Workshop.

Issues concerning the allocation of research funds in the drug and alcohol field have been widely debated. A consensus workshop involving senior researchers and policy makers was convened to examine the appropriateness of current drug and alcohol research activities in Australia. The workshop identified several major barriers restricting research developments including lack of monitoring of research efforts, limited community support, inappropriate allocations of research funds which contributed to a low level of intervention studies, the lack of application of research findings by practitioners and ethical constraints in studies involving Aboriginal populations and in multi-centre trials. Agreement was reached on 16 recommendations which could increase the amount of high quality research in Australia directed at reducing the harm associated with alcohol, tobacco and other drug use. Strategies which funding bodies could use to encourage intervention studies were identified. A proposal for the Australian Medical and Professional Society on Alcohol and other Drugs to establish a Researchers' Group to encourage implementation of the recommendations was also endorsed by workshop participants.

Journal Article↗

Real-world vehicle emissions: a summary of the twelfth Coordinating Research Council On-Road Vehicle Emissions Workshop.

The Coordinating Research Council (CRC) held its 12th workshop in April 2002, with nearly 90 presentations on the most recent on-road vehicle emissions research. This paper summarizes the presentations from researchers who are engaged in improving understanding of the contribution of mobile sources to air quality. Participants in the workshop discussed mobile source emission models and emission inventories, results from gas- and particle-phase emissions studies from spark-ignition and diesel-powered vehicles (with an emphasis in this workshop on particle emissions), effects of fuels on emissions, evaluation of in-use emissions control programs, and efforts to improve our capabilities in performing on-board emissions measurements, as well as topics for future research.

Air Pollution↗

Real-world vehicle emissions: A summary of the 15th coordinating research council on-road vehicle emissions workshop.

The Coordinating Research Council held its 15th workshop in April 2005, with nearly 90 presentations describing the most recent mobile source-related emissions research. In this paper, the authors summarize the presentations from researchers who are engaged in improving our understanding of the contribution of mobile sources to air quality. Participants in the workshop discussed emission models and emission inventories, results from gas- and particle-phase emissions studies from spark-ignition and diesel-powered vehicles (with an emphasis in this workshop on particle emissions), effects of fuels on emissions, evaluation of in-use emissions control programs, and efforts to improve our capabilities in performing on-board emissions measurements, as well as topics for future research.

Air Pollutants↗

Assessment and management of residential radon health risks: a report from the health Canada radon workshop.

Epidemiologic studies of uranium miners and other underground miners have consistently shown miners exposed to high levels of radon to be at increased risk of lung cancer. More recently, concern has arisen about lung cancer risks among people exposed to lower levels of radon in homes. The current Canadian guideline for residential radon exposure was set in 1988 at 800 Bq/m(3). Because of the accumulation of a considerable body of new scientific evidence on radon lung cancer risks since that time, Health Canada sponsored a workshop to review the current state-of-the-science on radon health risks. The specific objectives of the workshop were (1) to collect and assess scientific information relevant to setting national radon policy in Canada, and (2) to gather information on social, political, and operational considerations in setting national policy. The workshop, held on 3-4 March 2004, was attended by 38 invited scientists, regulators, and other stakeholders from Canada and the United States. The presentations on the first day dealt primarily with scientific issues. The combined analysis of North American residential radon and lung cancer studies was reviewed. The analysis confirmed a small but detectable increase in lung cancer risk at residential exposure levels. Current estimates suggest that radon in homes is responsible for approximately 10% of all lung cancer deaths in Canada, making radon the second leading cause of lung cancer after tobacco smoking. This was followed by a perspective from an UNSCEAR (United Nations Scientific Committee on the Effects of Atomic Radiation) working group on radon. There were two presentations on occupational exposures to radon and two presentations considered the possibility of radon as a causative factor for cardiovascular disease and for cancer in other organs besides the lung. The possible contribution of environmental tobacco smoke to lung cancers in nonsmokers was also considered. Areas for future research were identified. The second day was devoted to policy and operational issues. The presentations began with a perspective from the U.S. Environmental Protection Agency, followed by a history of radon policy development in Canada. Subsequent presentations dealt with the cost-effectiveness of radon mitigation, Canadian building codes and radon, and a summary of radon standards from around the world. Provincial representatives and a private consultant were given opportunities to present their viewpoints. A number of strategies for reducing residential radon exposure in Canada were recognized, including testing and mitigation of existing homes (on either a widespread or targeted basis) and changing the building code to require that radon mitigation devices be installed at the time a new home is constructed. The various elements of a comprehensive national radon policy were set forth.

Air Pollutants, Radioactive↗