ethical gatekeepers of clinical research

... confidentiality of information exist on the part of the researcher? Although medical records in a clinical trial are confidential, the security of the records is a serious concern, given the state history of ... http://www.globalizationandhealth.com/content/3/1/10 research This fundamental deficiency means that they have largely been ignored by the medical profession A logical consequence of a strict construction of Article of the Code and Article of ... Populations As the costs of research increase it is no wonder that pharmaceutical companies are looking to developing nations to conduct much of their research Much of the marketing of multinationals...

Ngày tải lên: 11/08/2014, 18:20

... traditional clinical research, beginning with the history of the development of clinical research, to traditional clinical research designs, with a focus on clinical trials It includes a discussion of ... chapter I will provide a brief overview of the history of clinical research The chapter will also address the question of why we clinical research; define clinical research ; discuss our quest for ... Ph.D., D.Sc Professor of Epidemiology, Department of Epidemiology School of Public Health, University of Alabama at Birmingham, Birmingham, AL Sue Duval, Ph.D Assistant Professor Division of Epidemiology...

Ngày tải lên: 14/08/2014, 11:20

... difference between clinical research and clinical trials A clinical trial is one type of clinical research A clinical trial is a type of experimental study undertaken to assess the response of an individual ... been one of the standards of clinical trials The use of the placebo comparator has more and more been the subject of ethical concerns In addition to ethical issues involved with the use of placebos, ... and issues common to all clinical research (eg ethical issues, blinding, selection of the control group, choice Clinical Trials 31 Table 3.1 Issues of importance for RCTs Ethical considerations...

Ngày tải lên: 14/08/2014, 11:20

... examined the association of rofecoxib (Vioxx) vs naproxen on the incidence of gastrointestinal events reported higher percentage of incident myocardial infarction in the arm of rofecoxib compared to ... Clearly, clinical practice would follow evidencebased medicine which is derived from the RCT and meta-analyses of RCTs But often the outcomes of clinical practice are not equal to that of the RCTs ... Exclusion of elderly people from clinical research: a descriptive study of published reports BMJ Oct 25, 1997; 315(7115):1059 5 Postmarketing Research 89 Corrigan OP A risky business: the detection of...

Ngày tải lên: 14/08/2014, 11:20

... Miller FG Ethical framework for the use of sham procedures in clinical trials Crit Care Med Mar 2003; 31(3 Suppl):S126–130 Macklin R The ethical problems with sham surgery in clinical research ... many of the other chapters In addition, the discussion of placebos requires an understanding of the ethics of clinical trials, intention to treat analysis, surrogate endpoints and many of the ... reasons for clinical improvement in a patient’s condition: (1) natural history of the disease; (2) specific effects of the treatment; (3) regression S.P Glasser (ed.), Essentials of Clinical Research, ...

Ngày tải lên: 14/08/2014, 11:20

... addition, in clinical research, the investigator is often in a dual role as it regards a patient-that of a treating physician and that of a researcher Long standing ethical rules apply to researchers, ... private offices, where the investigator and staff might not have experience in clinical research This privatization of clinical research began in the 1990s predominantly due to the inefficiencies of ... potential of industry supported research studies 144 S.P Glasser Differences in Dealing with Clinical Trial Patients There are differences in the handling of clinical patients in contrast to research...

Ngày tải lên: 14/08/2014, 11:20

... area of clinical pharmacology.1 In this chapter, we discussed general concepts of clinical research with emphasis on those related to PE In the last few years, PE has acquired relevance because of ... a newer field of Implementation Research – that is, how to implement the research findings that are published, into everyday practice On being asked to talk on the principles of research, my first ... of illnesses and tailoring of specific treatments to genetic profile Practicing physicians and health professionals need to be knowledgeable in the principles, applications, and limitations of...

Ngày tải lên: 14/08/2014, 11:20

... www.nap.edu/catalog/11884.html.) Chapter 14 Research Methodology for Studies of Diagnostic Tests Stephen P Glasser Abstract Much of clinical research is aimed at assessing causality However, clinical research can also ... al updated the definition of implementation research as: the scientific study of methods to promote the rapid uptake of research findings, and hence improve the health of individuals and populations.6 ... working knowledge of this field In other words, although traditional clinical research designs can be used to assess some of these questions, most of the studies assessing the value of diagnostic...

Ngày tải lên: 14/08/2014, 11:20

... probability of occurring (i.e 80% or 0.8) The odds of its occurring is 0.8/10.8 or 4:1 Odds then, are a ratio of probabilities Note that an odds ratio (often used in the analysis of clinical trials) ... researchers input the correct information This means, of course, that the researcher must understand the function of each input parameter and the reasonableness of the values entered If No Software, ... the probability of A and B (A & B)_occurring is not equal to the probability of A times the probability of B If the probability of A & B is equal to the product of the probability of A times the...

Ngày tải lên: 14/08/2014, 11:20

... degree of correlation, adapted to the nature of data The rate of change of one variable tied to the rate of change of another is known as a slope The correlation coefficient and the slope of the ... cause of y, then the presence of x necessarily implies the presence of y However, another cause z, may alternatively cause y Thus the presence of y does not imply the presence of x The majority of ... ‘describes the systematic tendency of any factors associated with the design, conduct, analysis, and interpretation of the results of clinical research to make an estimate of a treatment effect deviate...

Ngày tải lên: 14/08/2014, 11:20

... colleagues it is tough to get funded Types of NIH Research Funding There are a number of types of NIH research funding, but of most relevance to clinical research are: Grant (investigator initiated) ... years of clinical training • Protects between 25% and 50% of their professional effort • must engage in patient-oriented research • must serve as a mentor to developing patient-oriented researchers ... (purchaser) Training awards Research career development awards Mentored NIH career development awards K01/K08 research /clinical scientist K23 and K24 patient oriented research Mentored research scientist...

Ngày tải lên: 14/08/2014, 11:20

... at risk (100 PYAR), where duration of follow up was based on time from ART initiation to date of development of OI or death, or date of their last clinic or research cohort study follow-up visit ... assess the level of underreporting in a larger number of patients in the clinic database who were not part of a research study For each analysis, we compared the overall incidence rates of the initial ... captured in the research cohort database, validating the quality of data capture of OIs in the research cohort database Discussion In a large HIV observational clinic database of patients receiving...

Ngày tải lên: 20/06/2014, 08:20

... planning of studies and ethical issues related to the obligation of the physician-researcher to study participants [5] In our studies, we acquire limited MRI sequences, which reduce the cost of research ... all of the relevant institutional human research and ethics committees overseeing our work These issues are not inconsequential and may add to the cost of research Whilst the incidence of clinically ... findings In the non -clinical research setting, any abnormality, even if finally diagnosed as benign, is a matter of medical and ethical concern: the researcher has a duty of care to the study participant...

Ngày tải lên: 09/08/2014, 10:22

... consideration of implementation research by members of research ethics committees We recommend that training on the particular features of implementation research be offered to those on research ethics ... care, is ethically commendable Implementation research should be guided more by the principles of social science research, with the clinical treatment of patients being governed by ordinary professional ... biomedical research The Declaration of Helsinki [6] on biomedical research states that a 'research protocol should always contain a statement of the ethical considerations involved ' However, the ten ethical...

Ngày tải lên: 11/08/2014, 05:21

... consideration of implementation research by members of research ethics committees We recommend that training on the particular features of implementation research be offered to those on research ethics ... care, is ethically commendable Implementation research should be guided more by the principles of social science research, with the clinical treatment of patients being governed by ordinary professional ... biomedical research The Declaration of Helsinki [6] on biomedical research states that a 'research protocol should always contain a statement of the ethical considerations involved ' However, the ten ethical...

Ngày tải lên: 11/08/2014, 16:21

... 1951 (62) Mean SAPS II score [1] 34 SOFA score values [2] at inclusion SOFA maximum SOFA mean during study period ICU duration of stay (days) Hospital duration of stay (days) 15 Dr Arthur Slutsky ... Thijs LG: The SOFA (Sepsisrelated organ failure assessment) score to describe organ dysfunction/failure On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive ... (6.7) Shown is a summary of patient characteristics from the SOAP study (n = 3147) Values are expressed as number (%), unless otherwise stated *Defined as clinical suspicion of infection and/or positive...

Ngày tải lên: 12/08/2014, 19:21

... What makes clinical research ethical? JAMA 2000, 283:2701-2711 Burke R: Minimal risk: the debate goes on Crit Care Med 2002, 30:1180-1181 Freedman B: Equipoise and the ethics of clinical research ... scientific and community members of the IRB When clinical research involves members of a vulnerable population, such as pregnant women, prisoners, children, or adults incapable of providing informed consent, ... acute care research in which it is not possible to obtain the consent either of the patient or of their proxy decision maker might proceed under a simplified version of the waiver of consent...

Ngày tải lên: 12/08/2014, 20:20

... total of 60 patients completed 48 weeks of treatment, the treatment group of 30 cases, control group 30 cases Two groups of clinical comprehensive therapeutic effect by P < 0.05, two groups of overall ... recurrence rate is high, because of the variability of the virus is relatively high, and the side effects of antiviral drugs also many.In recent years, research on the mechanism of Chinese medicine for ... dialectical treatment shows certain superiority A OBJECTIVE: To observe the clinical effects of the Chinese herb (The Clinical Research of the Therapy Zhengxuxielian combined with interferon for Treating...

Ngày tải lên: 13/05/2016, 16:39

... The absence of stainable iron is the “gold standard”, for diagnosis of IDA Marrow examination shows, in addition to the absence of hemosiderin iron, a decrease in the proportion of sideroblasts, ... identify clinical and biochemical variables that predict the outcome of upper/lower endoscopy in outpatients with iron deficiency anemia The aim of our study was to investigate the incidence of GI ... that rate of clinically significant lesions in IDA with positively symptoms-sign or laboratory results The presence of advanced age (>50 years), male gender, diarrhea, lost weight, change of bowel...

Ngày tải lên: 25/10/2012, 11:18

... marketing research Keywords agencies conclusive research creativity customer research epistemology ethics in-house research market research ontology performance research preliminary research primary research ... AM Page Chapter • Nature of marketing research Any definition of marketing research has to take account of the changing role of research in modern marketing Marketing research connects the consumer, ... • Chapter 13 looks at a variety of examples of applied marketing research, including product research, segmentation research, competition research and promotion research EOM_A01.qxd 6/23/05...

Ngày tải lên: 13/12/2013, 14:15