In the "Design and Conduct of Clinical Trials" course, offered by Johns Hopkins University, participants will delve into the critical aspects of clinical trial design and implementation. This comprehensive learning experience covers the evaluation and selection of clinical trial designs, bias control measures, randomization procedures, and the definition of clinical trial outcomes.
Throughout the course, learners will explore modules focusing on bias control through randomization and masking, various trial stages and designs, outcomes in clinical trials, ethical issues in clinical trials regarding informed consent, as well as recruitment and retention strategies.
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The course modules cover crucial topics such as bias control, trial stages and designs, outcomes in clinical trials, ethical issues in clinical trials, and recruitment and retention strategies.
The "Bias Control: Randomization and Masking" module explores the importance of bias control, randomization, and masking in clinical trials. Learners will gain insights into practical tips for randomization, addressing confounding factors, and the ethical implications of bias control.
The "Trial Stages and Designs" module delves into the various stages of clinical trials and different design components. Participants will learn about hypotheses, dose finding, parallel design, factorial design, crossover design, and step-wedge design, providing them with a comprehensive understanding of trial phases and designs.
In the "Outcomes in Clinical Trials" module, learners will explore the influence of different types of outcomes on study design, including composite and surrogate outcomes. This module equips participants with the knowledge to define and evaluate suitable outcomes for their clinical trials.
The "Ethical Issues in Clinical Trials: Informed Consent" module focuses on the ethical considerations of informed consent in clinical trials. Participants will understand the consent document, consent process, and ethical issues related to obtaining informed consent from trial participants.
Within the "Recruitment and Retention" module, learners will gain insights into the principles, background, and strategies for recruitment, site selection, planning, and real-world recruitment. Additionally, the module addresses monitoring and retention, ensuring participants understand the essential aspects of recruiting and retaining trial participants ethically and effectively.
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