ethical considerations in clinical trials

... often intuitively more understandable by clinicians Thus, it is typical for a clinical treatment study in psychiatry to be designed mainly 46 Chapter 8: Clinical trials to describe a change in depressive ... analyses in such a large sample The primary outcome of the study was a comparison of aspirin versus streptokinase for prevention of myocardial infarction, with a finding in favor of aspirin In subgroup ... kind of measurement, such as points on a depression rating scale This measurement can be defined in various ways; for example, it can reflect the actual change in points on a depression rating...

Ngày tải lên: 01/11/2013, 11:20

... status Ascertaining the minimal clinically important difference Control Clin Trials 1989, 10:407-415 Juniper EF, Guyatt GH, Willan A, Griffith LE: Determining a minimal important change in a disease-specific ... instrument for assessing symptom severity and response to treatment in clinical trials of patients with GERD 10 11 12 Competing interests The authors declare that they have no competing interests 13 ... The baseline characteristics and clinical information for patients with data from both a baseline and subsequent visit are provided in Table GERD was proven in 82% of subjects while in 18% the...

Ngày tải lên: 18/06/2014, 22:20

... antidepressants, including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors [5,6] The trials in this analysis all included patients ... Montgomery-sberg Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials Int Clin Psychopharmacol 2002, 17:281-285 ... Montgomery-sberg Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials: a replication analysis Int Clin Psychopharmacol...

Ngày tải lên: 08/08/2014, 23:21

... gastrointestinal adverse events, we included an overall measure of gastrointestinal tolerability as well as individual gastrointestinal adverse events of nausea, vomiting, abdominal pain, dyspepsia, ... anti-inflammatory drug Clinical ulcers and bleeds Clinical ulcers and bleeds in the company clinical trial reports were as reported by investigators, and were not subjected to independent, blinded ... company clinical trial reports Deeks and co-workers [29] examined 15,000 patients in nine of the earlier trials of celecoxib, and Edwards and co-workers [30] examined some 5,700 patients in nine trials...

Ngày tải lên: 09/08/2014, 06:22

Ngày tải lên: 09/08/2014, 07:20

... in clinical trials that is paramount There are few comparisons on which to draw, although it is generally assumed that discontinuation rates are higher in clinical practice than in clinical trials ... discontinuations with placebo in This does not prevent discontinuations from being a useful measure, perhaps as much or more so in clinical practice as in clinical trials, although discontinuations ... in clinical trials in rheumatology, as with meloxicam in ankylosing spondylitis [37] In clinical practice, discontinuation rates for adverse events and lack of efficacy has been used to distinguish...

Ngày tải lên: 09/08/2014, 10:23

... with ionizing radiation and other DNA-damaging agents in pre -clinical studies [75] Recent pre -clinical data have suggested that it may act, in part, by inhibiting DNA repair resulted in a synergistic ... hematological and solid malignancies Vorinostat clinical trials have been updated lately [13,74] This review focuses on recent development in clinical trials testing newer HDAC inhibitors as anti-tumor agents ... was concluded to have insufficient activity for further investigation in this patient population [96] Clinical trial in lung cancer exhibited minimal clinical efficacy Nineteen patients with...

Ngày tải lên: 10/08/2014, 22:20

... databases contain information on all institution-specific research projects, only non-industry studies labelled as clinical trials involving adults will be eligible for inclusion Principal investigators ... benefits might be attained when deciding whether to participate in a clinical trial Furthermore, the related findings that DAs improve understanding, that improved understanding can increase trial participation ... understanding of consent forms and alternatives of care in phase I clinical trials Am Soc Clin Oncol 1997 Daugherty C, Banik D, Janish L, Ratain M: Quantitative analysis of ethical issues in phase trials: ...

Ngày tải lên: 11/08/2014, 05:21

... databases contain information on all institution-specific research projects, only non-industry studies labelled as clinical trials involving adults will be eligible for inclusion Principal investigators ... benefits might be attained when deciding whether to participate in a clinical trial Furthermore, the related findings that DAs improve understanding, that improved understanding can increase trial participation ... understanding of consent forms and alternatives of care in phase I clinical trials Am Soc Clin Oncol 1997 Daugherty C, Banik D, Janish L, Ratain M: Quantitative analysis of ethical issues in phase trials: ...

Ngày tải lên: 11/08/2014, 16:21

... further information As the aim cannot be to obtain informed consent in a legal meaning from legal minors or young children, the primary target of clinical investigators in clinical studies with an ethical ... both the feasibility of providing information about clinical trials according to informed consent criteria and the understanding of information related to clinical trials The appreciation of children ... of clinical trials were investigated The answers were analysed using qualitative methods to gain insight into the decision-making process of children and adolescents Analysis was conducted in...

Ngày tải lên: 13/08/2014, 18:21

... significant treatment effect Inefficient analysis of trials may contribute this the failure • Dichotomous analysis of an ordinal outcome scale in clinical trials results in loss of information Previous ... simulation study evaluating approaches to the analysis of ordinal outcome data in randomized controlled trials in traumatic brain injury: results from the IMPACT Project Clin Trials 2010, 7:44-57 ... JM, Whitehead J: Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial GAIN International Investigators Lancet 2000,...

Ngày tải lên: 14/08/2014, 08:21

... valuable information for first-line therapy Infrastructure for clinical trials In the remainder of the article, we have set forward our thoughts on infrastructure issues to support clinical trials ... regulations Financial support for clinical trials The effective conduct of clinical trials requires a major commitment of time and other resources An ongoing commitment to clinical trials in gynecological ... clinical trials, and all the physicians and patients must be encouraged to participate in the trials increase into clinical trial recruitment, already exceeding the government set targets Gaining...

Ngày tải lên: 13/02/2014, 07:20

... goods Clinical trials - an overview Classification of clinical trials Clinical trials of medicines Medical device trials Regulation of medicine and medical device clinical trials in Australia An Introduction ... 67 67 67 Reporting of adverse reactions during a clinical trial of medicines 69 Definitions Reporting of adverse reactions occurring in clinical trials Clinical trial event reporting algorithm ... Administration Classification of Clinical Trials Clinical Trials of Medicines Clinical trials of medicines are generally classified according to the phase of the medicine’s development While individual...

Ngày tải lên: 07/03/2014, 08:20

... shipping of blood in insulated containers by contracted overnight carriers is associated with large seasonal variations in temperature inside the packaging, ranging from -1°C in winter to 35°C in ... changes in temperature inside packages of blood specimens during shipping in the U.S., 2) changes in temperature inside packages simulating hot or cold ambient temperatures during shipping, and ... holder Each type of shipping container was tested for its ability to maintain temperature in cold ambient conditions (e.g.: during winter months) Forty heparinized vacutainers were filled with...

Ngày tải lên: 18/06/2014, 19:20

... integration of biomarker development from the preclinical through the clinical trial process T cell therapy clinical trials The concept of enhancing cellular immunity through the transfer of ex-vivo ... endogenous and infused T cells with equal efficiency, definitive quantification of infused cells using this approach is not possible This approach has been used in a number of clinical trials to evaluate ... evaluated and confirmed in primate models [64], and a number of clinical trials are being planned at multiple institutions that involve the specific transfer of memory cell populations into patients A...

Ngày tải lên: 18/06/2014, 22:20

... integration of biomarker development from the preclinical through the clinical trial process T cell therapy clinical trials The concept of enhancing cellular immunity through the transfer of ex-vivo ... endogenous and infused T cells with equal efficiency, definitive quantification of infused cells using this approach is not possible This approach has been used in a number of clinical trials to evaluate ... evaluated and confirmed in primate models [64], and a number of clinical trials are being planned at multiple institutions that involve the specific transfer of memory cell populations into patients A...

Ngày tải lên: 20/06/2014, 04:20

... between the two disciplines in clinical research Primary care settings provide unique opportunities to improve the methodology of clinical trials Traditionally, clinical trials in depression primarily ... check -in from their primary care physician inviting them to participate in a study of the usefulness of telemedicine in evaluating patient symptoms Those who were interested in participating completed ... results as when administered face-to-face [11-20] The current study examined the feasibility of identifying, recruiting and screening primary care patients for clinical trials, and examined patient...

Ngày tải lên: 08/08/2014, 23:20

... multiple domains are relevant when evaluating the effects of treatment Several considerations are important in deciding what domains should be considered in any clinical trial The domains should ... assessing multiple areas of functioning and well-being In addition to relieving clinical symptoms and prolonging survival, a primary objective of any intervention is improvement of functioning ... are what distinguish global ratings from other measures, and such ratings provide sufficient unique information to warrant inclusion in all clinical trials of treatments for chronic pain Symptoms...

Ngày tải lên: 09/08/2014, 01:23

... taking a history, performing a physical examination, ordering laboratory examinations, giving guidance and advice, delivering medication and therapy, specifying follow-up [17] Reports combining ... meeting the inclusion criteria for the review based their measures of behaviour on whether a clinician had performed one or more clinical actions, e.g., prescribing a specific drug, ordering ... EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Science/Social science citation index, Current contents (social and behavioural med/ clinical med), ISI conference proceedings, and Index...

Ngày tải lên: 11/08/2014, 05:21