How Clinical Trials Work
Your comprehensive guide to understanding clinical research from start to finish
Written by
Sarah Mitchell
MSN, RN
Clinical Research Nurse
Medically reviewed by
Dr. Michael Chen
MD, PhD
on December 15, 2024
Understanding Trial Phases
Clinical trials progress through distinct phases, each designed to answer specific questions about safety and effectiveness
Preclinical: Laboratory & Animal Testing
Participants: No human participants
Purpose: Test safety and efficacy in lab settings before human trials
Your Journey as a Participant
What to expect from initial interest to trial completion
Finding the Right Trial
Search databases or work with your doctor to identify trials for your condition
Screening & Eligibility
Meet with the research team to determine if you qualify for the trial
Informed Consent
Review all trial details and sign consent forms if you decide to participate
Baseline Assessment
Complete initial tests and evaluations to establish your starting health status
Treatment Period
Receive the study treatment and attend regular monitoring visits
Follow-up
Continue monitoring after treatment ends to track long-term effects
Your Safety is Our Priority
Multiple layers of protection ensure participant safety throughout every trial
Institutional Review Board (IRB)
Independent committee that reviews and monitors all trials to protect participant safety and rights
Informed Consent Process
Detailed explanation of risks, benefits, and your rights before you decide to participate
Data Safety Monitoring Board
Independent experts who regularly review trial data to ensure participant safety
Right to Withdraw
You can leave a trial at any time, for any reason, without affecting your regular medical care
Regular Safety Checkups
Frequent monitoring of your health throughout the trial with immediate access to medical care
FDA Oversight
All trials must follow strict FDA guidelines and undergo regular inspections
Common Questions
Get answers to frequently asked questions about clinical trial participation
Will I receive a placebo?
Not all trials use placebos. When they do, you'll be informed during consent. Many trials compare new treatments to existing standard care rather than placebos.
What costs am I responsible for?
The study treatment and trial-related tests are typically free. Your regular medical care and travel costs may or may not be covered. Always clarify costs upfront.
Can I continue my current medications?
It depends on the trial. Some medications may interfere with the study treatment. The research team will review all your medications during screening.
What if I experience side effects?
You'll have 24/7 access to the medical team. All side effects are closely monitored and treated. You can withdraw from the trial at any time if needed.
Will my privacy be protected?
Yes. Your personal information is kept confidential and protected by HIPAA laws. Published results never include identifying information.
How do I know if a trial is legitimate?
Legitimate trials are registered on ClinicalTrials.gov, have IRB approval, never ask for payment to participate, and provide detailed informed consent.
Important Documents to Understand
Key paperwork you'll encounter during the trial process
Informed Consent Form
- Detailed explanation of the trial
- All known risks and benefits
- Your rights as a participant
- Contact information for questions
Clinical Trial Agreement
- Schedule of visits and procedures
- Compensation details if applicable
- Insurance and injury coverage
- Data sharing and privacy policies
Ready to Learn More?
Take the next step in your clinical trial journey with confidence