Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Advisory Committees”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 55 records · Page 3Linked to original sources
PubMed2003

[Suggestions for better management of the Tuberculosis Advisory Committee].

Since 1951 tuberculosis advisory committee, established according to the tuberculosis control law, has played an important role in improving the quality of tuberculosis control programme in Japan. The management of tuberculous patients has changed markedly in the past ten years due to advances in chemotherapy and changes in the epidemiological situation of tuberculosis. In this paper, several suggestions were made on better management of the tuberculosis advisory committee intending to judge cases by unified criteria.

Advisory Committees↗
PubMed2006

Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.

CONTEXT: In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings. OBJECTIVES: To characterize financial conflict disclosures at drug-related meetings, and to assess the relationship between conflicts and voting behavior at meetings that considered specific products. DESIGN AND SETTING: Cross-sectional study using agendas and transcripts from all FDA Drug Advisory Committee meetings (2001-2004) listed on the FDA Web site. MAIN OUTCOME MEASURES: Conflict rates, type, and size. The relationship between having a conflict and voting in favor of the index drug was described for each voter using Mantel-Haenszel relative risks and Monte Carlo simulations; Spearman rho was used for a meeting-level analysis comparing rates of conflict with voting patterns. The impact of the removal of persons with conflicts of interest on the vote margins was also evaluated. RESULTS: A total of 221 meetings held by 16 advisory committees were included in the study. In 73% of the meetings, at least 1 advisory committee member or voting consultant disclosed a conflict; only 1% of advisory committee members were recused. For advisory committee members (n = 1957) and voting consultants combined (n = 990), 28% (n = 825) disclosed a conflict. The most commonly specified conflicts were consulting arrangements, contracts/grants, and investments. Nineteen percent of consulting arrangements involved over 10,000 dollars, 23% of contracts/grants exceeded 100,000 dollars, and 30% of investments were over 25,000 dollars. The meeting-level analysis did not show a statistically significant relationship between conflict rates ("index conflict," "competitor conflict," or "any conflict") and voting patterns, but a weak, statistically significant positive relationship was apparent for competitor conflict and any conflict in the Mantel-Haenszel analyses. The Monte Carlo analyses produced similar findings in the competitor conflict analysis only. In all 3 conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of meetings, but this would not have changed whether the majority favored or opposed the drug. CONCLUSIONS: Disclosures of conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members. A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.

Advisory Committees↗
PubMed2005

Financing vaccines in the 21st century: recommendations from the National Vaccine Advisory Committee.

In 2003, the National Vaccine Advisory Committee (NVAC) formed a working group to examine recommendations related to vaccine financing contained in the 2003 Institute of Medicine report on financing immunizations, "Financing Vaccines in the 21st Century: Assuring Access and Availability." During 2003-2004, the working group conducted a series of activities leading to a meeting with stakeholders in June 2004. Based on these discussions and meetings, NVAC recommended that the Department of Health and Human Services (DHHS) not adopt the Institute of Medicine (IOM) recommendation to replace the current immunization financing system with an insurance mandate and system of subsidies and vouchers. NVAC instead proposed substantial, but incremental, changes to the current system that would go a long way toward stabilizing the financing of immunizations in the United States. The proposed changes include expanded and stable funding for the existing immunization grant program, expansion of the Vaccines for Children program, regulatory harmonization, promotion of "first dollar" insurance coverage for immunizations, and the assurance of adequate reimbursement for the administration of vaccines.

Advisory Committees↗
PubMed1987

The provision of dietetic services to diabetics in the United Kingdom. Nutrition Sub-Committee of the Medical Advisory Committee of the British Diabetic Association.

Data on dietetic services to the diabetic in the United Kingdom was sought from dietitians and doctors, from Regional Health Authorities, from patients through local branches of the British Diabetic Association, and by detailed examination of dietitian's work loads in some districts. Considerable deficiencies are demonstrated in the provision of dietetic care and education to the diabetic in the country. A minimum provision for direct diabetic care and education of 15 hours of dietetic time per 100,000 of population per week is required. The data collected indicates that diabetes occupies some 25 per cent of total dietetic time in any one district. Individual district and unit managers should ensure that adequate numbers of WTE are available to offer this continuing commitment. Difficulties may arise in allocating exclusive responsibility for diabetic dietary education to any one individual. However, in any one district, one senior dietitian could be allocated the task of co-ordinating diabetes education and ensuring that all members of the dietetic staff and the diabetic team are kept up to date with all dietary developments. It is of considerable concern that some districts have no diabetic dietetic service or a very rudimentary one. It is of concern that even in districts provided with dietetic cover, the provision may vary by two- to three-fold.

Diet, Diabetic↗
PubMed2001

What did we learn about national organizational collaboration at the advisory committee level?

This article provides an overview of the typical roles and tasks of advisory groups in general, followed by a discussion of the roles and tasks the Interdisciplinary Generalist Curriculum (IGC) Project Advisory Committee was asked to assume and how these were fulfilled. It analyzes the lessons learned about advisory committees as a result of the IGC Project experience. Key elements of success in fulfilling advisory committee obligations include well-defined expectations, periodic evaluations, and clear communication between project leadership and the members of the advisory committee. In the spirit of lessons learned from the IGC Project, this critique identifies several philosophical and logistic issues that might be considered in the design and implementation of future projects, such as the need to choose committed, high-energy advisory committee members who are willing to perform many complex, time-consuming tasks.

Curriculum↗
PubMed2004

[Are tuberculosis advisory committees well-functioning?].

PURPOSE: To evaluate the function status of TB advisory committee to assess treatments of tuberculosis. OBJECT AND METHOD: Estimate by questionnaire sheets to public health nurses attending to seminars on tuberculosis at Research Institute of Tuberculosis. RESULT: 137 answers are available for analysis. Of these, 57 (41.6%) TB advisory committees are estimated not to assess treatments of tuberculosis at all and/or to assess treatments without necessary informations on drug sensitivity in more than around half of the cases. In 13 (16.3%) committees of the other 80, many cases are in fact self-assessed. Number of committees that are estimated to functioning well is only 44 (32.1%). CONCLUSION: Many TB advisory committees are estimated to be malfunctioning from the stand point of assessments of treatment. As TB advisory committee is one of key agency to control drug-resistant tuberculosis, its reform and revitalization are urgently needed.

Advisory Committees↗
PubMedDate not supplied

Comments on the sixth report of the Animal Welfare Advisory Committee.

The Animal Welfare Advisory Committee (AWAC) was established in July 1996, to consider the care, welfare and use of animals involved in procedures for defence research purposes at Defence and Evaluation Research Agency (DERA) establishments in the UK. Two of the objectives of AWAC are to examine the broad trends in animal use at DERA establishments, and to implement and audit the application of the Three Rs principle. AWAC's sixth report addressed the period from 31 October 2000 to 28 February 2002. The statistics of animal use within the report are briefly examined, and some of the actions undertaken by defence research establishments to facilitate the application of the Three Rs are highlighted. It is recommended that, if possible (subject to security constraints), figures detailing the severity of the procedures undertaken should be included in future issues of the report, in order to provide a more-detailed account. It is concluded that Defence Science and Technology Laboratory establishments have made a contribution to the Three Rs, and that other establishments may be able to incorporate some of their actions into their own research programmes. There was an overall 36% increase in the number of procedures carried out by defence research establishments between 1995 and 2000, from 8,900 to 12,065. This probably reflects alterations in the research programme, which is, in turn, decided primarily by the Ministry of Defence's customers and the progress made with previous research programmes. It is therefore recommended that the UK Government allocates significantly more financial resources for the development and validation of alternatives, in order to maximise the potential for achieving the Three Rs in defence research, and to complement the existing initiatives within the defence research industry.

Animal Experimentation↗
PubMed1984

National need for neurologists: commentary on the GMENAC report: (Graduate Medical Education National Advisory Committee).

In an incomplete study, the Government Medical Education National Advisory Committee in 1980 suggested that there would be an oversupply of neurologists by 1990. A subsequent Advisory Committee undertook an in-depth evaluation, concluding that neurology would be in near balance by 1990. Several factors that were not used by the Advisory Committee could alter these conclusions, depending on the weight given to these factors separately or collectively. We do not have enough evidence to justify any action now to control the growth of neurology.

Humans↗
PubMed1996

Research ethics and the medical profession. Report of the Advisory Committee on Human Radiation Experiments.

The Advisory Committee on Human Radiation Experiments was convened by President Clinton in January 1994 in response to allegations of unethical practices in radiation experiments involving human subjects that were sponsored by the US government between 1944 and 1974. The committee's Final Report was released in October 1995. In addition to analyzing the history of the ethics of medical research involving human subjects, the committee reviewed current federal policies and procedures for protection of human subjects. In this article, the committee's findings are discussed as they relate to the patient-physician relationship, the issue of trust, and the specific role of the physician-investigator in all types of human experimentation. The committee found evidence of discussion of the conduct of human research at the highest levels of the government and within the medical profession, particularly with regard to risk, during the 1940s and 1950s. However, in both federal policy and professional practice, requirements for consent were more likely to apply to "healthy volunteers" than to patient-subjects (ie, those with disease or illness). Today, consensus exists that duties to obtain informed consent apply to all human subjects, whether healthy or sick, regardless of the risk or potential for medical benefit from participation in the research and regardless of the nature of sponsorship or funding (eg, federal, military, or private). Based on a finding of serious deficiencies in the current system of protections for human subjects, the committee offers a number of recommendations, including changes in institutional review boards; in the interpretation of ethics rules and policies; in oversight, accountability, and sanctions for ethics violations; and in compensation for research injuries. More than public policy changes, however, the committee recommends that the medical profession intensify its commitment to the ethics of research involving human subjects.

Advisory Committees↗
PubMed1996

US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments.

The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.

Advisory Committees↗
PubMed2006

The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study.

BACKGROUND: The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. OBJECTIVE: This article compares the decision-making process of the FDA's Nonprescription Drugs Advisory Committee (NDAC) in 3 cases of a proposed switch from prescription to over-the-counter (OTC) status involving a nicotine replacement therapy product, 2 statins, and an emergency oral contraceptive. METHODS: This comparative case study reviewed written transcripts and slides from 4 NDAC committee meetings and a digital video disc recording of a later meeting held to reconsider one of the proposed switches. The focus was on the committee's discussion and deliberation processes. Content analysis and iterative coding were used to assess the level of participation by committee members and the extent to which committee discussion adhered to both the key draft list questions provided by the FDA and the published DeLap criteria for switches from prescription to OTC status. Other major themes and discussion topics were identified, and the voting process was analyzed. RESULTS: In the absence of clearly defined meeting procedures, the advisory committees developed their own procedural standards. There were major differences between meetings in terms of the extent of discussion of the key draft list questions and adherence to the DeLap principles, discussion of other themes and topics, and voting methods. In each case, at least 1 major topic of discussion was not directly related to safety, efficacy, or self-use. Additional identified themes were the public health significance of a switch to OTC status, costs, and access. CONCLUSIONS: Variability in processes created discrepancies in the decision-making criteria used by the NDAC committees. There is a need to establish structured procedures to achieve an optimal level of uniformity and transparency in advisory committee processes.

Advisory Committees↗
PubMed1994

Adult immunization. Summary of the National Vaccine Advisory Committee Report.

In January 1994 the National Vaccine Advisory Committee adopted a report that reviewed the status of adult immunization in the United States. Vaccine-preventable infections of adults represent a continuing cause of morbidity and mortality. Their major impact is among older persons. Effective and safe vaccines against these diseases are available, but they are poorly used. Several reasons account for low immunization levels among adults, including inadequate awareness by health care providers and the public of the importance and benefits of vaccination. Health care providers often fail to take advantage of opportunities to immunize adults during office, clinic, and hospital contacts and fail to organize programs in medical settings that ensure adults are offered the vaccines they need. Inadequate reimbursement for adult immunization by public and private health insurers and a lack of federal programs to support vaccine delivery are also major problems. The National Vaccine Advisory Committee's report includes five goals and 18 recommendations for improving adult immunization. To reach the Public Health Service adult immunization goals for the year 2000, the Committee recommends (1) improvements in public and provider education; (2) major changes in clinical practice; (3) increased financial support by public and private health insurers; (4) improved surveillance of vaccine-preventable diseases and vaccine production and delivery; and (5) support for research on vaccine-preventable diseases, new and improved vaccines, immunization practices, and international programs for adult immunization.

Adult↗
PubMedDate not supplied

Once-daily antiretroviral therapies for HIV infection: Consensus Statement of an Advisory Committee of the International Association of Physicians in AIDS Care.

OBJECTIVE: Adherence is essential to successful virologic outcome of highly active antiretroviral therapy (HAART). Documented factors contributing to poor adherence include toxicity, food requirements, and pill burden. Once-daily antiretroviral therapies for HIV infection offer potential benefit by decreasing pill burden and dosing frequency, which may subsequently improve treatment adherence. This Consensus Statement is intended to offer guidance to physicians actively involved in HIV/AIDS care. PARTICIPANTS: Eight physicians with expertise in HIV medicine were invited by the International Association of Physicians in AIDS Care (IAPAC) to serve on an ad hoc Advisory Committee. CONSENSUS PROCESS: IAPAC convened the Advisory Committee in June 2002 to develop a draft Consensus Statement. Scientific and clinical research, and other data in published literature and abstracts from scientific conferences were considered by strength of evidence. A Subcommittee updated the Consensus Statement in October 2002 to reflect relevant data presented at the XIV International AIDS Conference and the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy. This document represents consensus agreement of the Advisory Committee. CONFLICT OF INTEREST DISCLOSURE: The International Association of Physicians in AIDS Care sponsored and coordinated the development of this Consensus Statement with an unrestricted educational grant from Bristol-Myers Squibb. The opinions expressed in this Consensus Statement represent only those of the Advisory Committee.

Anti-Retroviral Agents↗
PubMed2003

Supplemental recommendations on adverse events following smallpox vaccine in the pre-event vaccination program: recommendations of the Advisory Committee on Immunization Practices.

The Advisory Committee on Immunization Practices (ACIP) has issued recommendations previously for use of smallpox vaccine and supplemental recommendations for use of smallpox vaccine in the pre-event civilian vaccination program. On March 28, 2003, CDC reported cases of cardiac adverse events among persons vaccinated recently with smallpox vaccine. In response to these reports, ACIP held an emergency meeting on March 28 to make recommendations to CDC about medical screening of potential vaccinees and follow-up of persons with cardiovascular risk factors after vaccination. These recommendations supplement those previously issued by ACIP.

Cardiovascular Diseases↗
PubMed2003

Using live, attenuated influenza vaccine for prevention and control of influenza: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report summarizes recommendations by the Advisory Committee on Immunization Practices (ACIP) for using intranasally administered, trivalent, cold-adapted, live, attenuated influenza vaccine (LAIV), which was approved for use in the United States on June 17, 2003 (FluMist trade mark, produced by MedImmune, Inc., Gaithersburg, Maryland). LAIV is currently approved for use among healthy persons (i.e., those not at high risk for complications from influenza infection) aged 5-49 years. This report includes information regarding 1) vaccine composition and mechanisms of action; 2) comparison between LAIV and trivalent inactivated influenza vaccine; 3) effectiveness and safety of LAIV; 4) transmission and stability of LAIV viruses; 5) recommendations and contraindications for using LAIV; and 6) dosage and administration of LAIV. This report supplements the 2003 ACIP recommendations regarding prevention and control of influenza (CDC. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2003;52[No. RR-8]:1-36.)

Adult↗