General Eligibility Criteria for Both Phases

Age Requirements:

• Usually 18+ years (some studies include pediatric participants)

• Upper age limits vary by study (typically 70-85 years)

• Some studies specifically target certain age groups

Medical Criteria:

• Adequate Performance Status: Able to care for yourself and be active for at least 50% of waking hours

• Lab Values: Normal or acceptable blood counts, liver function, kidney function

• No Serious Medical Conditions: That could interfere with the study or put you at risk

Lifestyle Factors:

• Reliable transportation to study site

• Ability to keep appointments and follow study schedule

• Support system to help with study requirements

• Geographic proximity to research center

  
  

Who May NOT Be Eligible

Medical Exclusions:

• Serious heart, liver, or kidney disease (unless that's what's being studied)

• Active infections or autoimmune disorders

• Other cancers (for cancer studies) within the past 5 years

• Pregnancy or breastfeeding

• Certain medications that could interfere with the study drug

Practical Exclusions:

• Unable to understand or sign informed consent

• History of not following medical instructions

• Substance abuse issues

• Participation in another clinical trial within 30 days

• Cannot commit to the study duration

Special Populations

Phase 2-3 Studies Often Include:

• Different ethnic and racial groups to ensure treatments work for everyone

• Both men and women (unless the condition is gender-specific)

• Various socioeconomic backgrounds

• International participants in multi-center studies

Priority Groups:

• Patients with limited treatment options

• Those who specifically request to participate in research

• Individuals referred by their current doctors

• Patients who meet rare disease criteria