Your oncologist may, at some stage in your treatment plan, suggest that you look at enrolling in a cancer clinical trial. This might be something you haven’t thought about before and perhaps you don’t understand what trials involve. Our next few blog posts will be a mini-series all about clinical trials including the questions you should ask and consider before enrolling.

Cancer clinical trials are performed to provide data to show if new treatments are better than the standard treatments already available. The idea is that they are looking for better ways to treat cancer, regarding outcome, side effects and toxicities, and quality of life. 

There is no right or wrong choice when it comes to deciding on whether to enroll in a clinical trial. The decision is very personal and depends on many factors, including the benefits and risks, and what you hope to achieve by taking part. It also depends on your own values, preferences, and beliefs. Having some background knowledge about what is involved in clinical trials in general, as well as any specific trial you are considering, can help you feel better about your decision.

General facts about cancer clinical trials

  1. Taking part in any clinical trial is voluntary.  You always have the right to choose whether to take part in a clinical trial that you are eligible for.  You also have the right to leave the clinical trial at any time and for any reason.  It is important to tell the trial doctors your reason for leaving, as if it is because of something to do with the trial, that gives them valuable information.  If it is for some other personal reason, that is fine too. The trial team may want to continue to monitor you for a while after you have left the trial for any long term or lingering effects of treatment. 
  2. Not all clinical trials study treatments. Some of them look at ways to diagnose or detect cancer. Others may look at how to prevent cancer.
  3. Those trials that do study treatments don’t just study new drugs and/or combinations of drugs. They can investigate: new surgery techniques, radiation techniques, natural medicines, mind-body medicines, or combinations of any of these.
  4. Placebos are very rarely used in cancer clinical trials, for ethical reasons.  It is not ethical to have someone take a placebo if there is a proven treatment available to them.
  5. Certain phases of trials compare the new treatment to a current standard treatment that is already in use.  Where possible, these studies are conducted “blind” which means the patient and doctor don’t know which treatment has been allocated to the patient. This helps to reduce bias in the study. Often, this may not be possible, for example if the study compares one drug given intravenously with the standard drug which is given orally.
  6. In order to enroll in a trial, you have to meet some specific eligibility criteria. Such criteria may include you having a certain: type or subtype of cancer; treatment history; age group; stage of cancer, etc. A clinical trial navigator will go through all the criteria with you.
  7. The aim of the study is to measure specific endpoints such as safety or effectiveness. It’s useful to specifically ask what the trial endpoints are and consider how they relate to your goals. Depending on the stage of cancer, the endpoints of cancer clinical trials may be:

Complete response (CR) which means that all detectable tumor has disappeared.

Partial response (PR) which corresponds to at least a 50% decrease in the total tumor volume, but evidence of some residual disease still remaining.

Stable disease (SD) which means either a small amount of tumor growth or a small amount of shrinkage.

Progressive disease (PD) which meant the tumor has grown significantly or that new tumors have appeared.

Overall Survival (OS) which looks at the percentage of patients alive at a defined period of time. OS is often reported as a five-year survival rate.

Progression Free Survival (PFS) which is the proportion of patients who continue to live with a disease that is not getting worse.

Quality of Life (QoL) which assess the effect of treatment on a patient’s wellbeing and ability to function in daily life.

8.  Before enrolling in a clinical trial, a patient will be asked to sign an informed consent form that states that they understand the research, its risks and benefits, and the patient’s rights.  You should be given adequate time to read this carefully and discuss it with your family and friends.  You will then have the opportunity to follow up with additional questions to the research team before making your decision.  You should keep your copy of the signed informed consent with your medical records. 

9. Clinical trials can be conducted at hospitals, clinics, doctors offices or universities, depending on the phase of the trial.  They are overseen by a principal investigator and each facility will have its own team of study personnel.  

10. The National Cancer Institute (NCI) sponsors (funds) a large proportion of the thousands of cancer clinical trials in the US. The NCI is part of the National Institutes of Health (NIH) which is funded by US tax dollars. Other government agencies often fund cancer clinical trials, such as Department of Veterans Affairs. The other main sponsors of trials are pharmaceutical and biotechnology companies who want to prove the safety and efficacy of their product before they can be sold and marketed. Additionally, trial sponsors can include doctors, academic medical centers, foundations, volunteer groups, and other non-profit organizations. 

In our next blog post of this series, we’ll look at the different phases of clinical trials and the relevance of the phase in your decision to enroll. 

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