Clinical Trials / edited by Timothy M. Pawlik, Julie A. Sosa.

Format:

Book

Contributor:

Pawlik, Timothy M., editor.

Sosa, Julie A., editor.

SpringerLink (Online service)

Series:

Medicine (Springer-11650)

Success in academic surgery 2194-7481

Success in Academic Surgery, 2194-7481

Language:

English

Subjects (All):

Surgery.

Medical education.

Medical Education.

Local Subjects:

Surgery.

Medical Education.

Physical Description:

1 online resource (VI, 258 pages) : 26 illustrations, 16 illustrations in color.

Edition:

Second edition 2020.

Contained In:

Springer eBooks

Place of Publication:

Cham : Springer International Publishing : Imprint: Springer, 2020.

System Details:

text file PDF

Summary:

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Contents:

History of Clinical Trials

Ethics (COI, informed consent)

Generating a Testable Hypothesis and Underlying Principles of Clinical Trials

Trial Design: Overview of Study Designs (phase I, II, III, IV, factorial design)

Defining the Study Cohort: Inclusion and Exclusion criteria (establishing eligibility and exclusion criteria, how should one define a cohort, balance between being inclusive versus selective / efficacy versus effectiveness trials)

Building your Clinical Trial Research Team (how to assemble the team: database manager, research nurse)

Clinical Trials: Ensuring Quality and Standardization (GCP, reporting of AE's, establishing SOPs, CRF's)

Device versus Drug Clinical Trials: Similarities and Important Differences

Statistics - Setting the Stage (Sample Size, Power, Randomization, Type II error, Treatment allocation/stratification)

Statistics - Handling the Data (Intention to Treat analyses, Subgroups analyses, expressing the data (relative risk), handling missing data)

Data Safety Monitoring Board: Interim Analyses, Stopping Rules

Planning for Data Monitoring and Audit

Clinical Trials: The Budget

Regulatory Issues (compliance issues, IRB, FDA)

Publishing your Clinical Trial (authorship, manuscript preparation, journal selection)

Pragmatic clinical trials

Cooperative trials

International trials

Inclusion of Patient Reported Outcomes

Participation in clinical trials/as a clinical trialist for the community surgeon. .

Other Format:

Printed edition:

ISBN:

978-3-030-35488-6

9783030354886

Access Restriction:

Restricted for use by site license.