A clinical trial is a set of studies conducted to find out whether a new treatment drug or protocol is better than another drug or treatment and assess if this potential new treatment is safe to give to people.

Whether or not your spouse should participate in a clinical trial, from the outset of treatment or after trying other treatments, is a complicated question with no set, correct answer. As with most other questions in this journey, do not assume that the doctor will tell you all about the perfect clinical trial from the outset. Many doctors, even well-meaning ones, will not tell you about a trial unless they or a close colleague are involved. Also, thousands of clinical trials are currently ongoing, and it is unreasonable to expect one person to know them all. So yet again, you have to do the research and ask the questions!

Factors to consider
Some of the question's you will need to answer are:

• Are there any trials for your spouse’s specific cancer or for that family of cancers?
• If there are such trials, are they suited to where your spouse is in treatment? For example, if your spouse has not yet started treatment, the trial would have to include those who have received other treatments first.
• Where are the trials located? Would you have to travel to participate in the trial? Is that possible for you to do as a couple or family?
• How good are the remission rates for the current standard treatment? How likely does it appear, from what you can tell from your research, that the clinical trial might be significantly better?

Often, people in clinical trials get closer monitoring than those in standard treatments and have the chance of finding something that works than standard treatments. However, the trade-off is that drugs used in clinical trials do not have a long history of use, so knowledge of the drug and its effectiveness is limited. Thus, it is important to know what phase the trial you’re considering is in.

Summary of the phases

Clinical trials are divided up into the four following phases:

Phase I: Determination of basic safety and dosage ranges for a particular drug. This type of study is done on a relatively small number of people.

Phase II: Determining if the drug or protocol works against a particular cancer.

Phase III: Comparing the results of a control group (people on a standard treatment) vs. the experimental group (the group getting the new drug or protocol). Examples: Do the tumors shrink more on the new drug? Are there fewer side effects with the same anti-cancer results for the new drug as compared to the old one? Generally, trials only get to Phase III if they have successfully passed Phases I and II. Phase III studies generally involve many more people in different locations.

Phase IV: After a drug is approved, doctors may run a Phase IV study to check for additional side effects not already uncovered in previous phases.
In deciding about clinical trials vs. other more standard treatments, it is vitally important that you do as much research as you can and ask the doctors questions. Only by finding out as much information as possible can you and your spouse decide whether or not a clinical trial is a good idea for his or her treatment.