Clinical trials take place in phases.
For a treatment to become part ofstandard treatment,itmust first go through 3 or 4 clinical trial phases.You do nothave to take part in all phases.The early phases make sure thetreatment is safe.Later phases show ifit works better thanthe standardtreatment.
What are clinical trials?
Clinical trials are research studies that involve people.They are the final step in a long process that begins with researchin a lab and animal testing.Many treatments used today arethe result ofpast clinical trials.In cancer research,clinical trials are designed to answerquestions about new ways to:
Find and diagnose cancer
Manage symptoms ofcancer or its treatmentThis bookletwillfocus on cancer treatment studies.Thesestudies are designed to answer questions about new treatments or new ways ofusing an old treatment and how wellthey work.These trials test many types oftreatments,such as new:
Ways to do surgery or give radiation therapy
Many treatments used today are the resultsofpastclinical trials.
Phase IPhase IIPhase IIIPhase IV
Number of peoplewho take part
15–30 peopleLessthan 100 peopleFrom 100 tothousands of peopleSeveral hundred toseveral thousandpeople
To find a safe doseTo decide how the new treatmentshould be givenTosee how the new treatmentaffects the human bodyTo determine if the new treatmenthas an effect on a certain cancerTo see how the new treatmentaffects the human bodyTo compare the new treatment (or new use of a treatment) withthe current standard treatmentTo further assess the long-termsafety and effectiveness of a new treatment