Essential Concepts in Clinical Research

"When you read that the authors of a book were proud to have "escaped the 1970s without owning a leisure suit," you just know it’s going to be good. Clearly, such authors have a different point of view-and a great sense of humor. Essential Concepts in Clinical Research is an accurate title; the book is a pragmatic guide to understanding and evaluating clinical research, and it is excellent. It is easy to read, contains a surprising amount of information for its size, and is well referenced. In addition to explaining the key points of epidemiological and clinical research designs, the book has lots of examples of good practices and bad mistakes, as well as several helpful flowcharts and illustrations. The authors write with humor (they somehow weave ancient Roman toilets and astrology into the mix) and with a great deal of authority. If you need to understand the clinical literature, this is probably the single best guide you can get." -Tom Lang, Tom Lang Communications and Training International"In this text physicians and allied health professionals will find a concise and insightful guide to the design and implementation of clinical research. Clearly written in short easy-to-digest chapters this text differs from other similar publications by providing practical clinical examples from the medical literature that highlight the concepts being discussed. Physicians, pharmacists and other allied health professions will find the insights offered by these authors to be invaluable in interpreting medical literature and established researchers will better understand how to optimize their conduct and interpretation of clinical research." -Robert Reid, Journal of Obstetrics and Gynecology Canada, 2019

• 1. An overview of clinical research: the lay of the landObservational studies2. Descriptive studies: what they can and cannot do3. Bias and causal associations in observational research4. Cohort studies: marching towards outcomes5. Case-control studies: research in reverse6. Finding controls for case-control studies: compared to what?7. Limitations of observational epidemiologyScreening tests8. Uses and abuses of screening tests9. Refining clinical diagnosis with likelihood ratiosRandomized controlled trials10. Boosting participant recruitment in trials11. Sample size calculations in randomized trials: mandatory and mystical12. Generation of allocation sequences in randomized trials: chance not choice13. Generation of allocation sequences in non-double-blinded randomized trials: guarding against guessing14. Allocation concealment in randomized trials: defending against deciphering15. Exclusions and losses in randomized trials: sample size slippages16. Blinding in randomized trials: hiding who got what17. Implementing treatment blinding in randomized trials18. Surrogate endpoints and composite outcomes: shortcuts to unknown destinations19. Multiplicity in randomized trials I: endpoints and treatments20. Multiplicity in randomized trials II: subgroup and interim analyses21. Conducting randomized trials as part of a prospective meta-analysisPublishing22. Reporting studies in medical journals: CONSORT and other guidelines