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Drug Trials (drug + trials)
Kinds of Drug Trials Selected AbstractsEthical Issues in Clinical Drug Trials in Alzheimer's DiseaseAUSTRALASIAN JOURNAL ON AGEING, Issue 3 2001Elizabeth G. Cleland No abstract is available for this article. [source] Randomized controlled trials in schizophrenia: a critical perspective on the literatureACTA PSYCHIATRICA SCANDINAVICA, Issue 4 2002S. Gilbody Objective:,The randomized trial provides an opportunity to minimize the inclusion of biases in the evaluation of interventions in psychiatry. Difficulties arise, however, when applying their results to `real world' clinical practice and decision-making. We, therefore, examined the real world applicability of schizophrenia trials. Method:,A narrative overview of the content and quality of the randomized trials relevant to the care of those with schizophrenia is provided. Results:,Complex, explanatory, under-powered randomized drug trials dominate evaluative research in schizophrenia. Conclusion:,Explanatory designs are a necessary but insufficient step in establishing the true worth of interventions in schizophrenia. Research from other spheres of mental health and wider health care suggest that pragmatic trials are feasible. This design allows large scale trials to be conducted which include patients which we would recognize from routine practice and which record outcomes which are of genuine interest to decision-makers. [source] Cell microarray platform for anticancer drug development,DRUG DEVELOPMENT RESEARCH, Issue 5 2007Min-Jung Lee Abstract Pharmacodynamic assessment of whether a drug has interacted with and modified its target is an essential component of molecularly targeted clinical trials. Although many trials are written with the intent to assess tumor biopsies, if available, thus far the great majority of early drug trials have used peripheral blood mononuclear cells (PBMC) as a tumor surrogate. Typically, PBMC are studied by low-throughput techniques such as Western blot. We present the use of a cell-based tissue microarray for assessment of anticancer drug activity in vivo. We demonstrate the utility of this technique for analysis of protein hyperacetylation in response to treatment with the histone deacetylase inhibitor, SNDX-275 in PBMC treated in vitro and in PBMC and bone marrow aspirates from patients in Phase I clinical trials with SNDX-275. We demonstrate that the cell microarray can be used to measure drug response in a high-throughput manner, allowing analysis of an entire trial on one or two glass slides. The cell microarray technique brings the advantages of the tissue microarray platform to the pharmacodynamic assessment of single cells, such as those isolated from bone marrow aspirates, fine needle aspirates, or malignant effusions, and to analysis of PBMC, the most commonly studied surrogate in oncology trials. Drug Dev Res 68:226,234, 2007. Published 2007 Wiley-Liss, Inc. [source] Differences in attitudes between patients with primary colorectal cancer and patients with secondary colorectal cancer: is it reflected in their willingness to participate in drug trials?EUROPEAN JOURNAL OF CANCER CARE, Issue 2 2005G. GARCEA mrcs Recruitment of patients into drug trials is essential in order to evaluate new treatments. Knowing why patients enter drug trials and their fears regarding them can be used in future research to ensure good recruitment and provide a supportive atmosphere for patients. Forty patients with colorectal cancer and 30 patients with colorectal liver metastases were asked to participate in a drug trial involving the oral consumption of a diet-derived agent of unknown therapeutic action. All patients agreeing or refusing to participate were asked to complete a short questionnaire with a series of options detailing the reasons behind their decision. Patients with colorectal hepatic metastases were motivated by altruism in entering the trial (e.g. helping others, helping the investigator) and displayed a realistic expectation that the drug would give little direct benefit to them. Patients with primary colorectal tumours were motivated by more ,selfish' reasons such as helping themselves and displayed an unrealistic expectation concerning any therapeutic benefit from the trial drug. Over 90% of all patients polled stated that their decision was made after reading the patient information leaflet. Patients with different stages of the same disease have very different fears and anticipations of drug trials, which need to be addressed specifically. The importance of the initial contact is demonstrated. Unrealistic expectations regarding the trial drug are common despite clear information to the contrary. [source] The clinical syndrome of Alzheimer's disease: aspects particularly relevant to clinical trialsGENES, BRAIN AND BEHAVIOR, Issue 3 2005R. C. Mohs This paper describes the natural history of the clinical syndrome of Alzheimer's disease (AD) including the cognitive deficit, the neuropsychiatric symptoms, impact on daily functioning, risk factors, medical complications and impact on the use of health-care resources. The clinical presentation of the disease varies greatly from the prodrome through end stage; instruments used to quantify the severity of each aspect of the disease have been developed and are described along with their use in clinical drug trials. Drug treatments for AD are usually developed by first showing a positive effect on the cognitive deficit, with later studies investigating drug effects on other clinical aspects of the disease. [source] Multicentre drug trials, ethics approval and death of patientsINTERNAL MEDICINE JOURNAL, Issue 4 2008J. A. Millar No abstract is available for this article. [source] Improving clinical descriptions to understand the effects of dementia treatment: consensus recommendationsINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 11 2002Kenneth Rockwood Abstract Objectives To recommend how the description of clinically detectable treatment effects might be improved for antidementia drug trials. Method Consensus conference, with review of available evidence. Results We suggest widespread, systematic, qualitative studies, based on prospective observations such as the clinicians' narrative descriptions of patient's changes used in the Clinician's Interview-Based Impressions of Change (CIBIC-Plus), plus caregiver input. The identification of patient and caregiver expectations, and an understanding of how these expectations are met, are proposed as priorities for future study. Conclusion Better descriptions of treatment effects can enhance our understanding of both clinical meaningfulness and cholinergic function in the brain. Copyright © 2002 John Wiley & Sons, Ltd. [source] Clinical trials and public trust: the geographical shift to the Asia-Pacific regionINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 3 2009Karina D. TORRALBA Abstract Multiple issues surrounding the publication of clinical trials and the conduct of clinical trials, especially those that are industry-sponsored, have raised doubts regarding the integrity of their results, and of the integrity of the medical profession. An appreciation of the historical and economic changes in the relationship between physicians and industry is crucial to the understanding of these issues. Increasingly, as healthcare professionals and centers in the Asia-Pacific region become involved in corporate-funded multi-center drug trials, these ethical issues similarly come into play. It is imperative for medical leaders to take actions ensuring rights of subjects participating in these clinical trials, and to ensure the integrity of physicians and authors of clinical trials from this region of the world. [source] Reproducibility of black blood dynamic contrast-enhanced magnetic resonance imaging in aortic plaques of atherosclerotic rabbitsJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 1 2010Claudia Calcagno MD Abstract Purpose: To investigate the short-term reproducibility of black-blood dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) in atherosclerotic rabbits to evaluate the potential of this technique to be a reliable readout of plaque progression and/or regression upon therapeutic intervention. Materials and Methods: Atherosclerotic rabbits were imaged at baseline and 24 hours later with DCE-MRI on a 1.5T MRI system. DCE-MRI images were analyzed by calculating the area under the signal intensity versus time curve (AUC). Intraclass correlation coefficients (ICCs) were used to evaluate interscan, intraobserver, and interobserver reproducibility. In addition, the test,retest coefficient of variation (CoV) was evaluated. Results: Statistical analyses showed excellent interscan, intraobserver, and interobserver agreement. All ICCs were greater than 0.75, P < 0.01 indicating excellent agreement between measurements. Conclusion: Experimental results show good interscan and excellent intra- and interobserver reproducibility, suggesting that DCE-MRI could be used in preclinical settings as a read-out for novel therapeutic interventions for atherosclerosis. This preliminary work encourages investigating the reproducibility of DCE-MRI also in clinical settings, where it could be used for monitoring high-risk patients and in longitudinal clinical drug trials. J. Magn. Reson. Imaging 2010;32:191,198. © 2010 Wiley-Liss, Inc. [source] Report of the Council for the session 2006,2007JOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES A (STATISTICS IN SOCIETY), Issue 4 2007Council Report President's foreword., This year's annual report shows another very successful year for the Society. The range of the Society's new initiatives bears testament to our vigour and to the energy and enthusiasm of Fellows and staff. It is difficult to summarize all of these but I offer a brief overview of some of the highlights. This year we have awarded the first annual prize for ,Statistical excellence in journalism'. It is too easy to bemoan the general quality of coverage of statistical issues in the press and other media. But simply moaning does not improve the situation. As a positive step, on the instigation of Sheila Bird and Andrew Garratt, the Society decided to initiate an award for the best journalistic coverage of a statistical issue. This year first prize was awarded to Ben Goldacre of The Guardian. I hope that these annual awards will offer a positive focus on good coverage and help us to promote best practice. This year, also, we have set up the Professional Development Centre to act as a focus for statistical training both for statisticians and for others who use statistical methods as part of their work. It thus reflects our support for continuing professional development for our Fellows and at the same time provides outreach to members of the statistical user community who want to improve their statistical skills. We welcome Nicola Bright as the Director of the Centre and wish her every success. I am pleased to say that it is not just the Society centrally that has taken new activities this year. The Manchester Local Group have initiated a prize for final year undergraduates from any higher education institute in the north-west. At a time when there are concerns about the number of well-qualified graduates coming into the statistics profession this seems an excellent way to attract the attention of final year undergraduates. I wish this initiative every success. Another development to which the Society has contributed is the Higher Education Funding Council for England project ,more maths grads' which is designed to promote participation in undergraduate degrees in the mathematical sciences. A good supply of mathematically trained graduates is essential to the UK economy in general and to the health of the statistics discipline in particular. It is good that the Society is involved in practical developments that are aimed at increasing participation. The final new initiative that I shall draw attention to is the ,first-in-man' report which is concerned with the statistical design of drug trials aimed at testing novel treatment types. The working party was set up as a result of the adverse reactions suffered by healthy volunteers to a first-in-man trial of monoclonal antibodies and who were subsequently admitted to Northwick Park hospital. The report makes a series of recommendations about the design of such trials and will, I hope, contribute to the safety of future trials. I would like to thank Stephen Senn and the members of the working party for their considerable efforts. As well as these new initiatives there were, of course, many other continuing activities that are noteworthy. The annual conference in Belfast was a great success with many lively sessions and a good number of participants. In particular it was good to see a high number of young statisticians participating in the conference, reflecting the continuing impact of the Young Statisticians Forum on which I commented in the previous annual report. Another continuing activity for the Society is the statistical legislation going through Parliament as I write. The Society has long campaigned for legislation for official statistics. The issue now is to try to get good legislation which will have the required effect and will help the Government Statistical Service and other statistical producers to produce high quality, authoritative statistics in an environment that commands public confidence. As first published, the Society was disappointed with the Bill but we have worked to build support for amendments that, in our view, are essential. Time alone will tell how effective the final legislation will be in meeting our aims. I would like to draw attention to the success of the Membership Services team. We, although with other statistical Societies, have experienced a decline in membership in recent years but the team have turned this round. They are helping to recruit new Fellows and to retain the commitment of existing Fellows. This is a fine achievement and I would like to thank Nicola Emmerson, Ed Swires-Hennessy and the whole team. Finally we have, at last, reached a conclusion in our dealings with the Privy Council and will implement the second phase of constitutional changes. In future our business year, financial year and year for elected appointments will all coincide on a calendar year basis. There will be transitional arrangements but in due course all our administrative arrangements will coincide and will improve efficiency and co-ordination. This has been a long journey, steered effectively by our Director General, Ivor Goddard, and I congratulate him for a successful outcome on your behalf. As you read this report, I hope that you will share my impression of a Society that is lively and spawning many new programmes. We have a dual commitment: to the well-being of statistics as a discipline and to the promotion of statistical understanding and practice to the benefit of Society at large. In both respects I feel that the Society is in good health. This is due to the unstinting efforts of a large number of individual volunteers, including in particular our Honorary Officers and also, of course, the staff at Errol Street. On behalf of all Fellows, I wish to express my thanks to everyone involved. Tim Holt [source] Clinical diagnosis and treatment of suspected neuropathic pain in three dogsAUSTRALIAN VETERINARY JOURNAL, Issue 1-2 2009RG Cashmore Three dogs were referred to The Queen's Veterinary School Hospital at University of Cambridge for chronic behavioural or locomotor disorders associated with pain. All three had been unsuccessfully treated with conventional analgesics, including non-steroidal anti-inflammatory drugs, glucocorticoids and opiate agonists, prior to referral, with minimal or no response. They were investigated by neurological examination plus conventional ancillary diagnostic tests and therapeutic drug trials. Ruling out other causes of pain and applying previously well-described criteria, each case was diagnosed as consistent with neuropathic pain, a poorly recognised condition in domestic dogs. Treatment with the tricyclic antidepressant drug, amitriptyline, or the antiepileptic drug, gabapentin, resulted in either a dramatic improvement or full resolution of clinical signs in all cases. [source] Limits of the applicability and generalizability of drug trials in maniaBIPOLAR DISORDERS, Issue 2002Rasmus W Licht Licht RW. Limits of the applicability and generalizability of drug trials in mania. Bipolar Disord 2002: 4(Suppl. 1): 66,68. ©Blackwell Munksgaard, 2002 During recent years, the majority of drug trials in mania have been conducted for the purpose of drug approval. On this background, this paper addresses to what extent these trials may actually provide the practising clinician with useful information. One major point is that selection prior to the point of randomization in RCTs in mania may limit the applicability of study results to patients seen in ordinary clinical practice. Limitations in study credibility and study design are also discussed. The need for large scale pragmatic studies using broad inclusion criteria, comparing the various treatments, alone or in combination, is emphasized. [source] PERSONAL DIGITAL VIDEO: A METHOD TO MONITOR DRUG REGIMEN ADHERENCE DURING HUMAN CLINICAL INVESTIGATIONSCLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 12 2006Chad C Carroll SUMMARY 1Maintaining patient adherence to a drug regimen has proven to be difficult. Missed doses can impact drug efficacy and disease control, leading to increased health-care costs. 2During clinical drug trials, poor adherence could lead to false conclusions regarding drug efficacy. Therefore, the purpose of the present study was to determine the feasibility of using personal digital video cameras to monitor adherence to a medication regimen during a clinical investigation. 3Older men and women (60,78 years) participated in a double-blind, placebo-controlled trial to determine the effect of ibuprofen or paracetamol on skeletal muscle adaptations to chronic resistance exercise training. Patients took three daily doses of either a placebo or the maximal daily over-the-counter dose of ibuprofen (1.2 g/day) or paracetamol (4.0 g/day) for 12 weeks. Prior to beginning the study, subjects were trained to use a personal digital video camera to record their drug consumption. 4Subjects correctly recorded 4956 of 5375 doses, resulting in an average camera compliance rate of 92% (71,100%). 5We describe a method of monitoring adherence to a prescribed drug regimen during a clinical investigation. Camera compliance rates, which directly confirm drug consumption, were higher than what is typically obtained with other methods of monitoring adherence. This camera compliance method provides the investigator with a simple and convenient means to generate direct evidence of drug consumption. [source] Prevention of sudden cardiac deathCLINICAL CARDIOLOGY, Issue S1 2005Eric N. Prystowsky M.D. Abstract It is often unclear why some patients suffer sudden cardiac death (SCD), or even what risk factors correlate best with the syndrome. This review describes current thinking on the prevention of SCD. Most studies have focused on the prevention of potentially fatal ventricular arrhythmias in patients post myocardial infarction (MI). While pharmacotherapy has a role in the prevention of SCD in patients post MI, the interpretation of drug trials can be problematic. This is because not all patients participating in such trials received optimized medical therapy by today's standards. As a result, trial outcomes for new therapies may not reflect their true efficacy when they are added to a background of best medical care. The two principal prophylactic modalities for SCD studied to date are antiarrhythmic drug therapy and use of an implantable cardioverter defibrillator (ICD). At the present time, antiarrhythmic drugs, such as the class III agent amiodarone, seem to display relatively limited efficacy for the primary prevention of sudden death in most patients post MI. Most clinical trials have found that ICD therapy has a significant mortality benefit in patients at high risk for ventricular arrhythmias. This has been demonstrated in primary prevention trials, and in secondary prevention trials such as Antiarrhythmics Versus Implantable Defibrillators (AVID), which studied patients who survived a near-fatal ventricular arrhythmia. Based on an analysis of secondary prevention trials, the single patient characteristic that best predicted an advantage of ICD therapy over antiarrhythmic drug therapy was a left ventricular (LV) ejection fraction , 35%. Cardiac resynchronization therapy has been established as having a mortality benefit in patients with dyssynchronous LV contraction associated with dilated cardiomyopathy. [source] | ||||||||||||||||||||||