Understanding Clinical Trials
Your guide to cancer research studies and how to participate
Quick Facts About Clinical Trials
- Clinical trials test new ways to prevent, detect, or treat cancer
- All current standard treatments were once tested in clinical trials
- Participation is always voluntary and you can leave at any time
- Trials follow strict scientific and ethical guidelines
- Many trials cover the cost of treatment and related care
- About 3-5% of adult cancer patients participate in trials
What Are Clinical Trials?
Clinical trials are research studies that test new ways to prevent, detect, diagnose, or treat diseases like cancer. They are essential for advancing medical knowledge and improving patient care.
Types of Cancer Clinical Trials
- Treatment Trials: Test new treatments or new ways to use existing treatments
- Prevention Trials: Test ways to prevent cancer in people who haven't had it or prevent recurrence
- Screening Trials: Test new ways to detect cancer early
- Diagnostic Trials: Test new procedures for diagnosing cancer
- Quality of Life Trials: Explore ways to improve comfort and quality of life
- Biomarker/Genetic Trials: Study genetic factors and molecular markers
Who Conducts Clinical Trials?
- National Cancer Institute (NCI)
- Pharmaceutical and biotechnology companies
- Academic medical centers and universities
- Cooperative research groups (SWOG, ECOG-ACRIN, etc.)
- Community hospitals and cancer centers
Clinical Trial Phases
Clinical trials are conducted in phases, each designed to answer specific research questions:
Phase 0
Purpose: Exploratory studies
Participants: 10-15 people
Focus: How the body processes the drug
Duration: Days to weeks
Very small doses to study drug behavior, not treatment effect
Phase I
Purpose: Safety and dosage
Participants: 20-100 people
Focus: Safe dose range, side effects
Duration: Several months
First studies in humans, dose escalation studies
Phase II
Purpose: Efficacy and safety
Participants: 100-300 people
Focus: Does it work? Further safety evaluation
Duration: Months to 2 years
Tests effectiveness in specific cancer types
Phase III
Purpose: Compare to standard treatment
Participants: 300-3,000 people
Focus: Is it better than current treatment?
Duration: 1-4 years
Randomized controlled trials, FDA approval basis
Phase IV
Purpose: Post-market surveillance
Participants: Thousands
Focus: Long-term effects, optimal use
Duration: Ongoing
After FDA approval, monitors real-world use
Finding Clinical Trials
Clinical Trial Search Resources
ClinicalTrials.gov
NIH database of all registered U.S. and international trials
Website: clinicaltrials.gov
NCI Clinical Trials Search
National Cancer Institute's trial database
Phone: 1-800-4-CANCER (1-800-422-6237)
Drug Company Trials
Check pharmaceutical company websites for sponsored trials
Cancer Centers
NCI-designated cancer centers often have many trials
Search Tips
Note: This is a demonstration interface. Visit ClinicalTrials.gov for actual trial searches.
Eligibility & Enrollment
Common Eligibility Criteria
Inclusion Criteria (Must Have)
Exclusion Criteria (Must Not Have)
Important Notes:
- Each trial has specific eligibility criteria
- Criteria ensure participant safety and valid results
- Not meeting criteria for one trial doesn't exclude you from others
- Your oncologist can help identify suitable trials
The Clinical Trial Process
Finding and Referral
- Identify potential trials through searches or physician referral
- Initial contact with trial coordinator
- Preliminary eligibility screening
Screening Visit
- Detailed eligibility assessment
- Medical history review
- Physical examination
- Required tests (blood work, scans, etc.)
Informed Consent
- Comprehensive explanation of trial
- Review of risks and benefits
- Time to ask questions
- Voluntary signing of consent form
- Right to withdraw at any time
Randomization (if applicable)
- Random assignment to treatment group
- May be blinded (you don't know which treatment)
- Ensures unbiased results
Treatment Phase
- Receive assigned treatment
- Regular monitoring visits
- Side effect reporting
- Required tests and procedures
Follow-up
- Continue monitoring after treatment
- Long-term outcome tracking
- Safety surveillance
- May continue for years
Benefits and Risks
✅ Potential Benefits
- Access to new treatments before widely available
- Close monitoring by research team
- Contribute to medical knowledge
- May receive effective treatment
- Often no cost for trial treatment
- Additional medical attention
- Help future patients
⚠️ Potential Risks
- Unknown side effects
- Treatment may not be effective
- More time commitment
- Additional tests and procedures
- May receive placebo (in some trials)
- Travel to trial site
- Insurance may not cover all costs
Your Rights as a Participant
- Participation is always voluntary
- You can leave the trial at any time
- Leaving won't affect your standard care
- Your privacy is protected by law
- You'll be informed of new risks or findings
- You can ask questions at any time
Questions to Ask
Important Questions for Your Trial Team
About the Trial
- What is the purpose of this trial?
- What phase is this trial?
- How long will the trial last?
- Has this treatment been tested before?
- What were the results of previous studies?
About Treatment
- What treatments will I receive?
- How is it given (IV, pills, etc.)?
- How often will I receive treatment?
- Will I know which treatment I'm getting?
- Can I continue my current medications?
About Risks and Benefits
- What are the possible side effects?
- How do risks compare to standard treatment?
- What happens if the treatment doesn't work?
- What are the alternatives to this trial?
Practical Matters
- How many visits are required?
- Will I need to stay in the hospital?
- Who pays for the treatment?
- Will insurance cover trial-related costs?
- Is travel assistance available?
- Who do I contact with problems?
Myths and Facts About Clinical Trials
Myth: Clinical trials are a last resort when nothing else works.
Fact: Trials are available for all stages of cancer, including newly diagnosed patients. Many offer the newest, most promising treatments.
Myth: I might get a placebo instead of real treatment.
Fact: Most cancer trials compare new treatment to standard care, not placebo. If placebo is used, you'll be informed and still receive standard care.
Myth: I'll be treated like a guinea pig.
Fact: Trials follow strict ethical guidelines. Your safety is the top priority, with close monitoring and the right to leave anytime.
Myth: Clinical trials are too risky.
Fact: Trials have extensive safety measures, ethics review, and informed consent. Many participants receive excellent care and outcomes.
Myth: My insurance won't cover it.
Fact: The Affordable Care Act requires most insurance to cover routine costs. The trial sponsor usually covers the investigational treatment.
Additional Resources
Important: This information is educational only. Discuss clinical trial participation with your oncologist to determine if it's right for your situation. Always review the specific trial's informed consent document carefully.