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Full Description
Every year, millions of people face life-threatening illnesses for which effective treatments are limited or nonexistent.
Yet only a small fraction of patients participates in clinical trials, even though these studies are vital to developing new therapies. Fewer than 8 percent of adult cancer patients take part in these trials, with even lower rates among Black and Hispanic populations. This gap is not merely due to a lack of interest; the clinical trial process can be daunting, often leaving patients and their families uninformed, unprepared and overwhelmed.
This book offers a much-needed, clear, balanced, and comprehensive guidance at a moment when patient-centered care has never been more important. It demystifies how trials work, what patients can expect, and how to weigh the promise of cutting-edge treatments against the challenges and potential risks involved. It simultaneously empowers patients and caregivers to make informed decisions, turning a process that can feel intimidating into one that is understandable, navigable, and ultimately hopeful.
Contents
Why I Wrote This Book
Introduction
Chapter 1. Understanding Clinical Trials: A Primer
What is a Clinical Trial?
Overview of the Clinical Trial Phases
Must All Drugs Complete Every Phase?
Overview of the Drug Development Process
Who is Responsible and Pays for a Clinical Trial?
Who Oversees Clinical Trials?
Ten Clinical Trials Myths
Chapter 1 Highlights
Chapter 2. Should You Join a Clinical Trial?
The Good, The Bad, and The Ugly: Real-World Cases of Extreme Success or Failure
Why People Participate in Clinical Trials
Understanding Potential Clinical Trial Risks and Burdens
Placebo, Blinding, Randomization, and Other Uncertainties
The Three Most Important Questions to Ask Yourself
How to Discuss Clinical Trials with Your Doctor
Chapter 2 Highlights
Chapter 3. Where to Start: Finding Clinical Trials
How to Search for Clinical Trials
A Step-by-Step Guide to Using ClinicalTrials.gov
Can Artificial Intelligence Chatbots Help to Find Clinical Trials?
Other Resources and Websites for Finding Trials
When No Trials Are Available
Is It a Clinical Trial or a Scam?
Chapter 3 Highlights
Chapter 4. Choosing the Right Clinical Trial
Key Questions Before Selecting a Trial
Ranking Clinical Trials: How To Prioritize Your Options
Learning More About the Experimental Therapy and Its Target
Becoming a Participant in a Clinical Trial
What Happens if a Trial is Delayed or Canceled?
Chapter 4 Highlights
Chapter 5. Inside the Clinical Trial: What to Expect
The Informed Consent Is the First Step of the Screening
Understanding Trial Criteria and Confirming Eligibility
What is a Screen Failure
After the Screening: Randomization and Additional Visits
Participants' Responsibilities and Commitment
What Happens if You Want to Stop Your Participation in a Trial?
Chapter 5 Highlights
Chapter 6. Practical and Emotional Support During the Trial
Financial and Medical Insurance Implications
Travel and Logistics Planning
Balancing Work, Family, and Trial Commitments
How Caregivers Can Support Trial Participants
Building a Support Network
What to Do When Things Go Wrong
Chapter 6 Highlights
Chapter 7. After The Trial: What Comes Next
What Happens at the End of Study Visit?
Open-Label Extension
Pros and Cons of OLE Participation
What if an Open-Label Extension is Not Available?
Do Clinical Trial Participants Feel Valued?
Accessing Clinical Trial Data and Results
Handling Negative Clinical Trial Results
Integrating Trial Results into Your Healthcare
Support Systems After the Trial
Chapter 7 Highlights
Chapter 8. Addressing Unique Populations in Clinical Trials
Clinical Trials in Children
Clinical Trials in Other Vulnerable Populations
Clinical Trials for Rare Diseases
Increasing Representation in Clinical Trials
Chapter 8 Highlights
Chapter 9. The Future of Clinical Trials: Innovation and Empowerment
How Could Drug Development and Clinical Trials Be Improved?
Decentralized Clinical Trials: Clinical Trials at (or Near) Home
AI and Digital Technologies
Could We Ever Get Rid of Clinical Trials?
The Most Important Innovation: Empowered Participants
Chapter 9 Highlights
Epilogue. Considering Clinical Trials: A Leap of Hope
Acknowledgments
Resources for Further Information
Glossary
Bibliography
About the Author
