Participating in Clinical Trials

Deciding whether to participate in a cancer clinical trial is a decision you need to carefully consider with your family members and doctors. It is important to make sure all your questions are answered before making the key decision to participate in a clinical trial. Participation may possibly enhance your overall medical treatment, however patients must look at the potential benefits and risks associated with any form of cancer treatment. Ultimately, your decision to participate will help future cancer patients and help advance cancer research studies.



Am I Eligible to Participate in a Clinical Trial?

Every clinical trial has specific guidelines stating who can join known as eligibility criteria.  Characteristics that participants must have are determined by strict guidelines listed in the protocol.  Eligibility criteria is different for every clinical trial because every trial is unique.

Before participating in clinical trials, you will receive health screenings and medical tests to make sure the trial is a good fit for you.  Patients that do not meet eligibility criteria may not participate in the clinical trial, but your doctor can see if there are other research studies you are eligible for. Eligibility criteria can include:

  • Age
  • Gender
  • Type and stage of cancer
  • Prior cancer treatment history
  • Other present medical conditions
  • Overall health status


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Clinical Trial Research Protocols

Every clinical trial has a detailed action plan that doctors must follow known as the protocol. The protocol will state what will be done in the research study and why.  This is prepared by the lead doctor in charge of the clinical trial, or principal investigator. These same protocols and guidelines must be followed by any doctor participating in the clinical trial. The protocols can include:

  • What the clinical trial is for
  • Who may participate (eligibility criteria)
  • How many participants are needed
  • The type of drugs being used, dosage levels, lab work, tests and drug schedule
  • How long the trial will last
  • The type of participant information researchers are going to collect

Patient Safety Protocols

Every clinical trial conducted in the United States requires there to be an Institutional Review Board (IRB) to approve and monitor the clinical trial. The IRB monitors the clinical trial to make sure the research study being conducted is safe and ethical for the clinical trial volunteers.  Members of the IRB usually consist of an independent group of doctors, scientists, nurses, lawyers, patient advocates, and people from the local community. They review the protocol before the trial begins and continually monitors the trial from beginning to end. IRB group members can make changes to the protocol, or end a trial, in the interest of patient safety.  The IRB is monitored by the U.S. Food and Drug Administration (FDA) who can oversee and review any clinical trial at any time they see fit.  


Costs for Participating in Clinical Trials

Your health insurance should cover your routine doctor visits, hospitalization, lab work and any treatment associated with treating your cancer.  The clinical trial sponsor will cover the costs of the study drug, and any extra lab tests or procedures that are performed strictly for the study.  You should discuss with your doctor and care team before you decide to participate how much your health insurance will cover as every health plan is different for every patient.

Furthermore, you also need to consider the additional time you will spend visiting the clinic where the trial is taking place and expenses if you do not live close by.  You may need to factor in extra transportation costs and child care expenses as well.  Some clinical trial sponsors may provide financial assistance with additional trial related costs.  Your care team will discuss this with you during the informed consent process.


Understanding Patient Informed Consent

Before you participate in a clinical trial, you must give your informed consent as part of the process.  This is where you learn details about the trial from your doctor or nurse before deciding whether to participate or not.  They will explain the trial details to you and be available to answer any questions and address any concerns you may have. Part of the discussion may include:

  • The purpose of the trial or protocol
  • Tests and procedures that will be used
  • Possible benefits and risks
  • How treatment will be administered
  • Eligibility criteria
  • Other treatment options available 
  • Who covers the cost of the trials and possible extra costs to you
  • Patient information they will collect
  • And your rights as a patient

Before you agree to participate, make sure to ask questions and feel satisfied that all your questions have been answered. It may help to ask trusted family and friends to help you with this process. If you agree to participate, you will be asked to sign the informed consent form. Once the clinical trial begins, if there are any changes or new information becomes available about the study, you will be told what those changes are.  Even though you sign the informed consent form and agree to participate, you are free to leave the study at any time you choose for any reason.


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