Clinical Trials
Clinical trials are research studies that involve people and test new medications or medical equipment to find out if they are safe and effective for patients. The only way that new treatments for diseases such as cancer can be approved in the United States is when they have proven to be safe and effective through clinical trials. On average, only about 3-4% of patients diagnosed with cancer in the U.S. enroll in clinical trials. Clinical trial participants are very special individuals who are helping themselves as well as helping future cancer patients.
A document called a protocol describes every detail about the trial.
|
What does a Clinical trial protocol include?
|
|
Study Background
|
What type of tumor is being studied, current treatments, new knowledge that support this trial, previous data for the new treatment.
|
|
Study Objectives
|
What the study goals are e.g. compare current drugs A and B for X cancer to the combination of A + B and new drug C.
|
|
Study Design
|
Number of patients to be enrolled, number of study groups or “arms,” randomized or not, blinded, placebo controlled, what benefits the study is looking for, how this will be measured, how will safety be monitored, will the study stop early for benefit or safety concerns. Study Phase I (dose finding of new drugs), Phase II (single group, no comparison), or III (2 or more groups receiving different treatments, comparative)
|
|
Eligibility Criteria
|
Describes all requirements for patients to be allowed to participate in the study such as age, gender, type of cancer, any previous treatment, stage of disease, other medical problems, vital organ function (liver, kidneys, blood counts, brain).
|
|
Study Calendar
|
A detailed calendar of all required visits, tests, treatment schedules.
|
|
Special Studies
|
Description of any special studies such as extra blood tests, biopsies, images, questionnaires that may be voluntary or required.
|
Read more about clinical trials by utilizing the links on the right.
Last Updated on 11/26/2012 6:15:25 PM