Cancer Clinical Trials Explained: Should You Participate? A Patient's Complete Guide (Part 2)
Last Updated: April 2025 | Medically Reviewed
Understanding Trial Eligibility Criteria
Every trial has strict inclusion criteria (what you must have) and exclusion criteria (what disqualifies you).
Common Inclusion Criteria:
✓ Specific cancer type and subtype
✓ Specific stage (metastatic, early-stage, etc.)
✓ Specific biomarkers (EGFR mutation, PD-L1 expression, etc.)
✓ Age range
✓ Performance status (ECOG 0-1, meaning able to perform daily activities)
✓ Adequate organ function (liver, kidney, bone marrow)
✓ Previous treatment history (sometimes need specific prior treatments, sometimes can't have had any)
Common Exclusion Criteria:
✗ Other active cancers
✗ Brain metastases (though some trials now include these)
✗ Poor organ function
✗ Autoimmune diseases (for immunotherapy trials)
✗ Recent heart attack or serious heart disease
✗ Pregnant or breastfeeding
✗ HIV, hepatitis (though changing for some trials)
✗ Recent surgery (within certain timeframe)
Frustration alert: You might match 90% of criteria but be excluded for one factor.
Why so strict?
Safety: Protect participants from treatments that might harm them
Scientific rigor: Reduce variables to better understand the treatment
Regulatory requirements: FDA requires specific trial designs
Important: Criteria sometimes relax as trials progress and more safety data is available.
Questions to Ask Before Enrolling in a Trial
About the Trial Design:
"What phase is this trial, and what is its primary goal?"
"Is this trial randomized? If so, what are the different arms?"
Make sure you'd be comfortable receiving ANY arm of the study
"Will I know which treatment I'm receiving?"
Some trials are blinded, some are open-label
"How many patients will be enrolled in this trial?"
Larger trials generally more definitive
"What is the rationale for this treatment? What earlier results suggest it might work?"
Look for Phase 2 data if it's a Phase 3 trial
Ask about response rates in earlier phases
About the Treatment:
"What does the treatment involve?"
How is it given? (oral pill, IV infusion, etc.)
How often?
For how long?
Where? (at home, in clinic, hospital?)
"What are the known and potential side effects?"
Common side effects
Serious side effects
Unknown risks (especially Phase 1-2)
"How does this compare to the standard treatment I would otherwise receive?"
"What happens if I have severe side effects? Can the dose be adjusted?"
"What other medications or treatments can't I take while on this trial?"
Some trials prohibit certain supplements, other medications
About Logistics:
"How often will I need to come for appointments?"
Weekly? Monthly? More frequent than standard care?
"Where do I need to go for treatment and follow-up?"
Can any visits be at my local oncologist?
What must be at the trial site?
"How long is the trial expected to last?"
Treatment period
Follow-up period
"What costs will I be responsible for?"
Trial covers experimental drug, but what about other costs?
Will insurance cover routine care costs?
Are there programs to help with travel/lodging?
About Outcomes and Next Steps:
"What happens when the trial ends?"
Can I continue receiving the treatment if it's helping?
What are the next treatment options?
"What if the treatment doesn't work? Can I leave the trial and pursue other treatments?"
You can ALWAYS leave a trial
But good to understand the process
"Will I find out the results of the trial?"
Some trials share results with participants
Timeline (trials can take years to complete and publish)
"Can I continue seeing my regular oncologist?"
Most trials encourage coordination with your regular team
About Safety and Oversight:
"Who is sponsoring this trial, and who is overseeing safety?"
Pharmaceutical company, NCI, academic institution?
IRB approval?
Data Safety Monitoring Board?
"What happens if I'm harmed by the trial treatment?"
What care is provided?
Is there compensation?
The Informed Consent Process
Before enrolling, you'll go through informed consent:
What It Includes:
Written consent form (often 20-30 pages) explaining:
Purpose of the trial
What you'll be asked to do
Treatments you might receive
Known risks and benefits
Alternative treatments
Your rights
Privacy protections
Costs
Verbal explanation from:
Principal investigator (lead doctor)
Research nurse
Clinical trial coordinator
Time to consider (never rush):
Take the consent form home
Review with family
Discuss with your regular oncologist
Ask questions
No pressure to decide immediately
Your Rights:
✓ Right to ask questions (any and all questions)
✓ Right to take time to decide
✓ Right to discuss with others (family, your oncologist, second opinion)
✓ Right to refuse without affecting your standard care
✓ Right to leave the trial at any time, for any reason, without penalty
✓ Right to receive all information about risks and benefits
Important: Signing consent is NOT a final commitment. You can withdraw at any time.
Making Your Decision: Should You Join This Trial?
Consider "Yes" if:
✓ You meet all eligibility criteria
✓ You'd be comfortable with ANY arm of a randomized trial
✓ The trial offers a treatment potentially better than standard care
✓ The logistics are manageable (location, time commitment)
✓ You understand and accept the risks
✓ Your regular oncologist supports the decision
✓ The trial aligns with your goals and values
Consider "No" or "Not Yet" if:
✗ You're not comfortable with the randomization or trial design
✗ The logistics are prohibitive (distance, time away from work/family)
✗ You have concerns about risks that haven't been adequately addressed
✗ Standard treatment is highly effective for your cancer
✗ You haven't fully explored standard options
✗ Your intuition says it's not right
Consider Getting a Second Opinion About the Trial:
Many patients benefit from discussing the trial with:
Their regular oncologist (if trial is elsewhere)
Another oncologist at a different institution
A patient advocate familiar with trials
AI-powered second opinion services that can compare the trial to standard options
Remember: This is YOUR decision. No one should pressure you either way.
What Happens If You Join a Trial
Enrollment Process:
Screening: Additional tests to confirm eligibility
Blood work
Scans
Biopsies
Other testing per protocol
Baseline assessment: Establish your starting point
Detailed medical history
Physical exam
Quality of life questionnaires
Tumor measurements
Randomization (if applicable): Assignment to treatment arm
Treatment begins: Following strict protocol schedule
During the Trial:
Regular monitoring:
More frequent appointments than standard care typically
Blood tests, scans, physical exams per protocol schedule
Side effect assessment and management
Quality of life questionnaires
Diaries or logs (some trials)
Strict adherence required:
Taking medication exactly as prescribed
Attending all appointments
Reporting all side effects
Not taking prohibited medications
Communication:
Regular contact with trial team
24/7 emergency contact for serious issues
Coordination with your regular oncologist
Your Ongoing Rights:
✓ Continue asking questions
✓ Report any side effects or concerns
✓ Request to speak with the principal investigator
✓ Leave the trial if you choose
✓ Access your medical records
What If You Don't Qualify for Any Trials?
Many patients are disappointed to find they don't meet eligibility criteria. Options:
Expand Your Search:
Look at trials at multiple institutions
Consider trials for related cancers
Check for "basket trials" (target specific mutations regardless of cancer type)
Look at prevention or supportive care trials
Ask About Compassionate Use:
Expanded access programs may provide experimental drugs outside trials
For patients with serious conditions who've exhausted other options
Contact drug manufacturers
Your oncologist can apply on your behalf
Focus on Optimizing Standard Care:
Not being in a trial doesn't mean inferior care
Standard treatments are proven effective
Consider comprehensive genomic testing to personalize standard approaches
Optimize supportive care
Keep Checking:
New trials open regularly
Your eligibility may change as your treatment evolves
Set up alerts on ClinicalTrials.gov for your cancer type
Special Types of Trials to Know About
Basket Trials
What they are: Trials that accept multiple cancer types sharing a specific genetic mutation
Example:
Trial for any cancer with NTRK fusion
Trial for any tumor with high microsatellite instability
Advantage: Expands options for rare mutations regardless of cancer type
Umbrella Trials
What they are: Multiple sub-studies under one master protocol
How it works:
All participants undergo genomic testing
Assigned to sub-study based on their mutations
Receive matched targeted therapy
Example: NCI-MATCH, Lung-MAP
Advantage: Personalized matching to treatment based on your tumor's specific characteristics
Window of Opportunity Trials
What they are: Brief treatment before planned surgery
Purpose:
See if treatment shrinks tumor
Study how treatment affects tumor biology
Doesn't delay your surgery
Advantage: Contribute to research without changing your standard treatment plan
Neoadjuvant Trials
What they are: Treatment BEFORE surgery (instead of or in addition to standard neoadjuvant therapy)
Purpose:
Shrink tumor to make surgery easier
Treat microscopic disease early
Test treatment response
Example: Immunotherapy before surgery for certain cancers
The Bottom Line: Clinical Trials and You
Clinical trials are how cancer care advances. Every effective treatment available today started in a clinical trial.
Should you participate? Consider it if:
✓ You want access to cutting-edge treatments
✓ You're comfortable with the trial design and logistics
✓ You understand and accept the risks
✓ You want to contribute to advancing cancer care
It's also perfectly okay to choose standard treatment if:
✓ Standard treatment is highly effective for your cancer
✓ Trial logistics are prohibitive
✓ You're not comfortable with uncertainties
✓ Your personal situation makes trial participation difficult
Key points to remember:
Trials are NOT just for desperate situations - many are for newly diagnosed patients
You rarely receive a placebo in cancer trials - usually comparing active treatments
You can leave at any time - enrollment is not a permanent commitment
Trials offer intensive monitoring - often more careful follow-up than standard care
Ask questions - lots of them - before making any decision
Get a second opinion about whether a trial is right for you
Your regular oncologist should support you whether you choose trial or standard care
Finding the right trial:
Start with your oncologist
Search ClinicalTrials.gov
Contact disease-specific organizations
Use trial matching services
Consider AI-powered matching for comprehensive search
Making your decision:
Take your time (when medically safe to do so)
Read the full consent form
Discuss with family and your care team
Trust your instincts
Make sure it aligns with your goals and values
Cancer treatment is increasingly personalized. Clinical trials are one way to access the most personalized, cutting-edge approaches, but they're not the only path to excellent care.
About Radical Health: We're building the world's first AI Oncologist to ensure every cancer patient receives expert-level, personalized treatment recommendations, regardless of where they live. Our AI platform analyzes over 10 million patient records and is overseen by oncologists from UCSF, MSK, UCLA, and Johns Hopkins. Learn more about AI-powered personalized report at https://radicalhealth.ai.
Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with qualified healthcare providers about your specific diagnosis and treatment options.