Back to Design and Interpretation of Clinical Trials
Johns Hopkins University

Design and Interpretation of Clinical Trials

Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US. The course will explain the basic principles for design of randomized clinical trials and how they should be reported. In the first part of the course, students will be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. Finally, we will review the essential ethical consideration involved in conducting experiments on people.

Status: Statistical Analysis
Status: Clinical Trials
Course10 hours

Featured reviews

CC

5.0Reviewed Jun 4, 2020

I would highly recommend this course as I found it well-structured and helpful. After studying all the materials, I gained a great amount of knowledge in designing and interpretating clinical trail.

LL

5.0Reviewed Jul 16, 2019

Very good course, I have post-diploma in Clinical Trials Management, but this course was a good reminder of what I've learnt so far. Strongly recommend to anyone interested in clinical trials.

TH

5.0Reviewed May 30, 2018

I was able to learn a lot from this course. The lectures and the sequence of the presentations were logical and clear to understand. I will definitely recommend this course for my colleagues.

SS

5.0Reviewed Jun 27, 2022

I'm a biomedical engineering student with some experience of conducting research level clinical experiments. This was a great course for me to understand the basics behind clinical trial designs.

NG

4.0Reviewed Oct 3, 2016

The powerpoints and audio lectures are very clear and concise, much appreciated. I would also appreciate more exercises or reading materials, to help solidify our understanding of the topics.

JG

5.0Reviewed Sep 6, 2020

A very good course for beginner to get a hang of how clinical trial works in real world setting. Instructors give lots of real Clinical Trials that help us link to the course materials.

VV

5.0Reviewed May 26, 2020

Simplified every aspect as much as possible .Take home message without technical jargon is the icing on the cake.Thank you so much. I would love to attend other courses from your university.

AH

5.0Reviewed Apr 27, 2020

This course does a good job of introducing fundamental concepts necessary in Clinical Trials. I would recommend this course to anyone looking to build a foundation of knowledge on the field.

NF

5.0Reviewed Feb 3, 2021

Great course! I was completely new to clinical trials, and now I feel that I can use what I learned to look for a job. Everything is explained very clearly. Thank you so much this course!

SJ

5.0Reviewed Aug 2, 2021

This course offered clear learning objectives and a clear presentation of materials, offering a solid foundational course for further learning or to complement existing industry experience.

B

5.0Reviewed Jun 28, 2022

T​he course covers what I consider an appropriate amount of information as an entry level course to clinical trials. i do like at the end you are given direction toward more learning resources.

TS

5.0Reviewed Jul 3, 2018

High quality course ! covering important areas and detailed lectures, more and better than a mere introduction. Congrats ! My only regret : I'd have liked to hear more about NI and equivalence trials

All reviews

Showing: 20 of 727

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