How Are Cancer Clinical Trials Conducted

After assessing the patient's disease and the necessary therapy for treating the disease, the doctor may consider a clinical trial for the treatment. When this happens he/she determines which particular cancer protocol might be appropriate. The doctor studies the protocol's eligibility criteria to see whether the patient is a potential candidate and offers the patient the cancer trial as a treatment option. The patient will be asked to first read the informed consent to more fully understand the trial before making any decisions. Once the consent form is signed, the patient's assignment into the study is randomized.


What is a protocol? A trial's protocol…

• provides the blueprint for how a trial is conducted:
  
  
• defines the trial's action plan
  
  
• explains the purpose of the clinical trial
  
  
• states the research question the trial is designed to answer
  
  
• defines who is and who is not eligible to participate
  
  
• outlines what will be done in the trial, for example how much of a drug will be given, how often it must be taken, and what medical tests will be required to check on the progress of the study.

• To define the entrance and exclusion factors to first protect the patient safety.
  
  
• To ensure that the new treatment or approach is being tested on similar groups of people, i.e. to compare apples to apples.
  
  
• To assure key similarities among participants, e.g., the same type and stage of cancer.

• Is a key part of a clinical trial. Participants should ask questions until he or she feels comfortable enough to make an informed consent.
  
  
• Is an ongoing process, meaning the participant should receive any new information about the treatment as it is learned.
  
  
• Explains key facts of the clinical trial - what will be done in the trial, what type of therapy will be conducted, i.e. radiation, chemotherapy, variation of drug dosages etc, and how long will the intervention last.
  
  
• States the potential benefits and potential risks of the clinical trial.
  
  
• States the possible side effects of treatment.
  
  
• Explains what kinds of tests will be conducted (x-rays, blood tests) during the trial to monitor study response.
  
  
• Means the participant understands what is involved in the trial, including its potential benefits and risks of participating.
  
  
• Must be signed by each participant. Individuals can freely decide to take part in the trial or not.

Why participants are Randomized? Researchers need for clinical trials to provide non-biased information. The randomization process eliminates bias. A clinical trial can have two or more treatment assignments (also referred to as 'arms') that are being examined. For example, a drug study may compare the dosage of Arm "a" to Arm "b" and Arm "c".

The randomization process is...

• To validate whether the new treatment (intervention) is superior to the standard (control) treatment.
  
  
• To prevent a bias or partiality in assignment to a specific group.
  
  
• A computer assignment to randomly and anonymously assign to insure that trial results are scientifically valid.