Outcomes research: collaboration among academic researchers, managed care organizations, and pharmaceutical manufacturers.
Medical and pharmaceutical outcomes research has been of increasing interest in the past 10 to 15 years among healthcare providers, payers, and regulatory agencies. Outcomes research has become a multidisciplinary field involving clinicians, health services researchers, epidemiologists, psychometricians, statisticians, psychologists, sociologists, economists, and ethicists. Collaboration among researchers in different organizations that offer different types of services and various research expertise is the essential element for any successful outcomes project. In this article we discuss collaboration on outcomes research among academic researchers (mainly those who work in colleges of pharmacy), managed care organizations, and research-based pharmaceutical manufacturers, with a focus on the opportunities and challenges facing each party. The pharmaceutical industry needs information to make product and promotion decisions; the managed care industry has data to offer but needs analysis of these data; and pharmacy schools, among other academic institutions, have skilled researchers and data-processing capacity but require projects for revenue, research training, experience, and publications. Challenges do exist with such endeavors, but collaboration could be beneficial in satisfying the needs of the individual parties. (+info
The involvement of genome researchers in high school science education.
The rapid accumulation of genetic information generated by the Human Genome Project and related research has heightened public awareness of genetics issues. Education in genome science is needed at all levels in our society by specific audiences and the general public so that individuals can make well-informed decisions related to public policy and issues such as genetic testing. Many scientists have found that an effective vehicle for reaching a broad sector of society is through high school biology courses. From an educational perspective, genome science offers many ways to meet emerging science learning goals, which are influencing science teaching nationally. To effectively meet the goals of the science and education communities, genome education needs to include several major components-accurate and current information about genomics, hands-on experience with DNA techniques, education in ethical decision-making, and career counseling and preparation. To be most successful, we have found that genome education programs require the collaborative efforts of science teachers, genome researchers, ethicists, genetic counselors, and business partners. This report is intended as a guide for genome researchers with an interest in participating in pre-college education, providing rationale for their involvement and recommendations for ways they can contribute, and highlighting a few exemplary programs. World Wide Web addresses for all of the programs discussed in this report are given in Table 1. We are developing a database of outreach programs offering genetics education () and request that readers submit an entry describing their programs. We invite researchers to contact us for more information about activities in their local area. (+info
Lymphopoietic cancer and other major causes of death among petrochemical researchers: an update.
This study updates lymphopoietic cancer (LHC) mortality statistics and other major causes of death through 1992 for 13,188 petrochemical researchers employed between 1964 and 1986. Significant deficits of deaths were observed for all causes, all cancers, ischaemic heart disease and all external causes. The subcategory of 'all other LHC' was elevated among males in an exposure class containing scientists and engineers. This finding was statistically significant based on national but not state comparison rates. Poisson regression analyses showed that increasing exposure classes were not associated with LHC, but a relationship was noted for total years worked. A non-significant increase in breast cancer among females was also observed but was concentrated among the lowest exposure class. This study and other similar investigations suggest various subcategories of LHC deaths are marginally elevated among chemical researchers and engineers. Evidence for a work-related LHC hazard for this population, however, has not been identified. (+info
Update of the Texaco mortality study 1947-93: Part I. Analysis of overall patterns of mortality among refining, research, and petrochemical workers.
OBJECTIVE: To update information on the workers of the Texaco mortality study to determine if the patterns of mortality have changed with 16 additional years of follow up. SUBJECTS AND METHODS: All workers were employed for > or = 5 years at company refineries, petrochemical plants, and research laboratories from 1947-93. The cohort now consists of 28,480 employees with an average of > or = 20 years of follow up. RESULTS: The overall mortality, and most cause specific mortalities were lower than or similar to those for the general population of the United States. For white men (86% of the cohort), there were 8873 observed deaths and 11,181 expected resulting in a significantly lower standardised mortality ratio (SMR) of 79. There were significant deficits for all the leading causes of death in the United States including all cancers, cancer of the lung, stroke, heart disease, respiratory disease, and accidents. Slightly increased mortality was found for cancer of the pancreas, cancer of the brain and central nervous system, leukaemia, and cancer of other lymphatic tissue. For cancer of the bone, the SMR was 162 (95% confidence interval (95% CI) 86 to 278), and for benign and unspecified neoplasms, it was 152 (95% CI 109 to 206). Overall mortality patterns for non-white men and women were similar to those for white men. Mortality patterns for white men were also examined by duration of employment, time first employed, location, and by job and process unit. There were significantly increased SMRs for brain cancer for those people employed as laboratory workers and on units with motor oil and for cancer of other lymphatic tissue for people employed on the fluid catalytic cracking unit. CONCLUSIONS: The results of the updated study showed a favourable mortality experience for employees in the Texaco mortality study compared with the United States population. There were a few increases found consistently including, but not limited to, brain cancer and cancer of other lymphatic tissue. These increases led to additional analyses that will be discussed in the accompanying paper. (+info
Update of the Texaco mortality study 1947-93: Part II. Analyses of specific causes of death for white men employed in refining, research, and petrochemicals.
OBJECTIVE: To examine patterns of mortality for specific causes of death with increases in the Texaco mortality study to determine if the patterns are related to employment in the petroleum industry. METHODS: Mortality patterns by duration of employment in various job groups were examined for mesothelioma, non-Hodgkin's lymphoma, multiple myeloma, cell type specific leukaemia, and brain tumours. RESULTS: Mortality from mesothelioma was examined for the total cohort and for two maintenance groups with the greatest potential for exposure to asbestos. The insulator group had a standardised mortality ratio (SMR) of 3029, and a larger group consisting of insulators, carpenters, labourers, electricians, pipefitters, boiler-makers, and welders had an SMR of 411. The mortalities from mesothelioma increased with increasing duration of employment. Mortality was lower for those first employed after 1950. An analysis of all brain tumours for the total cohort and some job and unit subgroups resulted in an SMR of 178 for those employed on the units related to motor oil and 166 for those employed as laboratory workers. Mortality from brain tumours in both of these job groups was higher for those employed > or = 5 years in the group. An analysis of non-Hodgkin's lymphoma showed no consistent patterns among the various employment groups. Mortality from multiple myeloma was non-significantly increased among people employed on the crude (SMR = 155) and fluid catalytic cracking units (SMR = 198). Leukaemia mortality was not increased for the total cohort, and a cell type analysis of leukaemia mortality for the total cohort showed no significant increases for the major cell types. However, there were significant increases for acute unspecified leukaemia (SMR = 276) and leukaemia of unknown cell type (SMR = 231). CONCLUSIONS: Analyses of specific causes of death by duration of employment in various job and process units did not show any patterns which suggest that, other than for mesothelioma, any of these increases in mortalities were likely to have resulted from workplace exposures or from employment at one of the places included in the Texaco mortality study. (+info
Fraud, misconduct or normal science in medical research--an empirical study of demarcation.
OBJECTIVES: To study and describe how a group of senior researchers and a group of postgraduate students perceived the so-called "grey zone" between normal scientific practice and obvious misconduct. DESIGN: A questionnaire concerning various practices including dishonesty and obvious misconduct. The answers were obtained by means of a visual analogue scale (VAS). The central (two quarters) of the VAS were designated as a grey zone. SETTING: A Swedish medical faculty. SURVEY SAMPLE: 30 senior researchers and 30 postgraduate students. RESULTS: Twenty of the senior researchers and 25 of the postgraduate students answered the questionnaire. In five cases out of 14 the senior researchers' median was found to be clearly within the interval of the grey zone, compared with three cases for the postgraduate students. Three examples of experienced misconduct were provided. Compared with postgraduate students, established researchers do not call for more research ethical guidelines and restrictions. CONCLUSION: Although the results indicate that consensus exists regarding certain obvious types of misconduct the response pattern also indicates that there is no general consensus on several procedures. (+info
Conflict-of-interest policies for investigators in clinical trials.
BACKGROUND: There is substantial concern that financial conflicts of interest on the part of investigators conducting clinical trials may compromise the well-being of research subjects. METHODS: We analyzed policies governing conflicts of interest at the 10 medical schools in the United States that receive the largest amount of research funding from the National Institutes of Health. These institutions are Baylor College of Medicine, Columbia University College of Physicians and Surgeons, Harvard Medical School, Johns Hopkins University School of Medicine, the University of Pennsylvania School of Medicine, the University of California at Los Angeles School of Medicine, the University of California at San Francisco School of Medicine, the University of Washington School of Medicine, Washington University School of Medicine at St. Louis, and Yale University School of Medicine. RESULTS: All 10 universities required that faculty members disclose financial interests to university officials. Only four required disclosure by all members of the research staff. Five universities required disclosure of all financial interests, even though federal regulations specify a threshold for disclosure. Six universities required disclosure to the institutional review board as well as to a committee on conflicts of interest or a university official. Four universities had stricter requirements for investigators conducting clinical trials than required by federal regulations. One university prohibited investigators from having stock, stock options, consulting agreements, or decision-making positions involving a company that sponsored the research. A second university prohibited researchers from trading stock or stock options in a company that sponsored the research or sold the product or device under study. Two universities ordinarily did not allow faculty members to participate in clinical research if they had what federal regulations refer to as a "significant" financial interest in the company owning the product or device being studied, but exceptions were allowed. CONCLUSIONS: Policies governing conflicts of interest at leading medical schools in the United States vary widely. We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research. Of the 10 medical schools we studied, only 1 had a policy that was close to this standard. (+info
A national survey of policies on disclosure of conflicts of interest in biomedical research.
BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity. (+info