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"This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials."

"Diantara peneliti ada perbedaan temuan klinis hasil ASST pada urtikaria kronik idiopatik (UKI). Tanuus dkk (1996) melaporkan tidak ada perbedaan klinis bermakna pada UKI, sedangkan Sabroe dkk (1999) menemukan perbedaan bermakna dalam hal durasi dan gatal pada UKI. Prevalensi urtikaria pada Rumah Sakit Dr. Moh. Hoesin Palembang memperlihatkan peningkatan tetapi tidak ada data mengenai UKI dan derajat gambaran klinis. Tujuan penelitian untuk mencari hubungan antara hasil ASST dengan derajat gambaran klinis UKI dan membandingkan gambaran klinis UKI dengan hasil ASST positif dan ASST negatif. Penelitian ini merupakan studi analitik dengan rancangan cross sectional. Lima puluh empat subjek diikutkan dalam studi setelah diseleksi. Persetujuan etik didapatkan dari Unit Bioetik dan Humaniora FK Unsri. Anamnesis UKI berupa gambaran klinis berupa skor klinis dan data hasil pemeriksaan fisik dikumpulkan dan dianalisis menggunakan piranti lunak SPSS. Korelasi Spiermann digunakan untuk menganalisis hubungan diantara derajat gambaran klinis UKI dengan hasil ASST. Ada hubungan bermakna diantara tingkat keparahan klinis UKI dengan hasil ASST (p=0,00; 0,598). Pasien UKI dengan skor 27 (nilai cut-off) 11 kali lebih sering menderita urtikaria autoimun daripada pasien dengan nilai cut-off dibawah 27 (p=0,00).

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There were differences in clinical finding among authors about autologous serum skin test/ASST result in chronic idiopathic urtikaria/CIU. Tanus et al (1996) reported there was no significant differences in clinical features of CIU, whereas Sabroe et al (1999) found significant differences in duration and itch of CIU patients. The prevalence of urticaria in General Hospital Dr. Moh. Hoesin Palembang showed increased tendency but there was no data about CIU and the severity of clinical features. The objectives of this study were to find out the significant correlation between ASST and severity of clinical features of CIU, and compared the difference of clinical features of CIU with and without positive ASST. This study was an observational analytic study, with cross sectional design. Fifty four subjects included in this study after following selection. Ethical approval was obtained from Bioethics and Humanities Unit, Faculty of Medicine Sriwijaya University and Dr. Moh. Hoesin Hospital Palembang. The clinical feature of 54 patients with CIU were evaluated. The data of physical examination and the anamnesis about clinical scores collected and analyzed using SPSS software and Spierman correlation was used to analyze the correlation between clinical severity of CIU and ASST result. Student?s t-test was used to analyze the differences in clinical severity of CIU with and without positive ASST. There was significant correlation between the severity clinical feature of CIU and ASST result (p=0,00 ; R=0,598). Patients with positif ASST results (46,3%) had more duration of illness (0,00), higher pruritus score (0,00), and angiodema score (0,024). The CIU patients with severity clinical score of 27 (cut-off point), 11 times more likely to develop autoimmune urticaria than the patients with cut-off below 27 (p=0,00)"

"In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis."

"The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular clinical trials : putting the evidence into practice, provides a succinct overview of recent major clinical trials, the gold standard for all medical treatment, across all the major cardiovascular subspecialties, to ensure you’re up–to–date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology."

"This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives."