Fundamentals of Clinical Trials 5th Edition by Lawrence M. Friedman (PDF)

Description

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. 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.Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.

User’s Reviews

Reviews from Amazon users which were colected at the time this book was published on the website:

⭐The pages are and cover are so strong I expect this to last 2 lifetimes. A must read, relevant and informative for those interested in statistical applications in clinical trials.

⭐Excellent book to get a better understanding regarding clinical trials. Well written. I just need to get a general understanding of what constitutes an acceptable trial so I am not sure how the information will work for someone actually conducting a trial though.

⭐Dry but thorough. A must for any clinician thinking of doing clinical trials.

⭐very well written and easy to read textbook, and that’s coming from a grad student who almost always hates doing the readings for class. no unnecessary jargon, in my opinion

⭐good

⭐Useful stats for clinical trials.

⭐Very useful even though I work in marketing research, not medicine.

⭐Very clear and detailed. Great book.

⭐Todo bien, en general. El libro llegó 8 días antes de la fecha límite prometida, aunque la bolsa del empaque llegó maltratada pero el libro no tuvo mayores consecuencias; volvería a comprar con el vendedor, lo recomiendo ampliamente. El libro es un excelente material para aquellos que requieren conocer lo relacionado a los ensayos clínicos, muy completo y enriquecedor.

⭐

⭐From population study to randomization, from recruitment to adherence, statistical analysis and regulatory issues, this book is a wealth of information… Very well-written!

⭐Although the text provides an important amount of methodological issues, there is almost nothing related to data analysis.

⭐The product given is the previous version that is 4th edition. But a new price tag was added making it 400₹ more than the original. Total fraud

⭐Torr och tråkig bok. Men den var obligatorisk kurslitteratur så vad gör man…

⭐

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