Patients & Families
Patients and Families
Clinical Trials FAQ

The following are questions that are often asked by patients who are thinking about taking part in a clinical trial. The answers are general answers. Every trial is different and if you are thinking of taking part in one, you should discuss your questions with your oncologist (cancer doctor) and the research coordinator. They will be able to give you more specific answers to your questions.

As well, there is a consent form for every clinical trial. The consent form will be reviewed with you before you sign it. The consent form should answer many of these questions. You will be given a copy of the consent form to keep.

Why should I choose a trial over normal care? What's in it for me?

You may receive a treatment that is better than the usual treatment. 
The usual treatment was once tested as part of a study. 
Treatments can only get better if people participate in clinical trials that may prove the new treatment to be better than the usual one.

You will be closley monitored because trials have guidelines that require specific tests and doctors visits. 
Not everyone has the same reasons for taking part in a clinical trial. Some patients find participating in a clinical trial gives them hope for themselves and for other cancer patients in the future.

Does this mean the normal treatment isn't as good as the trial treatment? How do I know that the study treatment is better than the usual treatment?

No. A clinical trial is done to try and find out if new treatments or ways of giving treatments are better than standard care. No one, including your doctor, nurse or study sponsor knows the result of the trial until all data is analyzed. The data can take many months or even years to analyze after a trial is finished. Even though clinical trials are being done to see if a treatment is effective and safe, all therapies studied in a clinical trial have gone through an extensive evaluation process to maximize the chance of success and minimize risks to patients.

Is the trial treatment less effective than the usual treatment?

The new treatment is thought to be better based on information gathered from previous studies (both clinical trials and basic science studies). 
It is not known which treatment will be better; that is why the clinical trial is being done.

Are there any extra costs to patient?

This is different for every trial. The clinical research associate will discuss the costs that are involved with you if you are thinking about taking part in a trial. The costs will also be listed in the consent form.

For most trials: 
The medicine that is being studied (the study drug) will be provided to you free of charge. 
If the trial involves radiation therapy, the radiation therapy is free. When radiation therapy is part of the usual treatment for cancer, it's paid for by the government. 

Standard medications that may not be part of the trial are not typically provided, but may be covered under a variety of other programs.

There may be extra visit and tests. This may mean more trips to the cancer centre, which could mean increased costs for gas, parking, etc. Some studies will reimburse patients for these extra costs, but it is not a general rule.

Are there any extra time commitments?

Many clinical trials require the patient to have more tests, and/or visits to the cancer centre. However, because of this, you will be very closely followed.

Can I get my treatment at my home hospital?

If the clinical trial involves a drug that is given by vein (IV), it is usually required that you receive treatment at the cancer centre. 
If the clinical trial involves radiation therapy, this is only available in Halifax or in Sydney.  However, many clinical trials are testing pills taken by mouth. In this case the medication can be taken at home.

What treatment would I get if I were not on the study?

You will be offered the usual treatment. Your team will discuss with you the choices available to you and make sure that you and your family fully understands all available treatments.

What happens after the study? Will I still be followed?

It depends on the study and what the researchers hope to find out. Some studies will follow patients for the rest of their lives. Other studies may only follow patients for a short period of time. The expected follow up will be explained to you by the clinical research associate for the trial you are considering. You will always recieve at least as much follow up as another patient with the same type of cancer who wasn't on the trial.

Are there any guarantees that I will benefit from being on the study?

Unfortunately, there are no guarantees because no one knows for sure which treatment is better, this is why the study is being done.

What happens if I go on the study and I get a lot of side effects or don't want to continue? Do I have to stay on the study?

You do not have to stay on the study. You can stop the study treatment anytime you wish for any reason. 
Sometimes, the doctor may stop the study treatment if he/she feels it is no longer in your best interest. 
Sometimes, the study guidelines require a patient to stop the study treatment if the patient has too many side effects. 
Patient safety is the most important aspect of all clinical trials.

Can my treatment change after I go on the study?

Yes, if the study treatment is not working for you, you will be offered another treatment. 
Again, if you wish to stop the study treatment at any time for any reason, you will receive the usual treatment that is available to patients with the same type and stage of cancer.

Can I quit the study if I don't get assigned the treatment that I wish?

If you plan from the beginning that you will quit if you do not get the treatment you wish, you should not take part in the study. You should be prepared to receive any of the treatments that are part of the study. 
Remember, we do not know which treatment is the best. That is why the clinical trial is being done.

Will my overall treatment suffer if I don't go on the study?

Whatever decision you make will be respected by your entire healthcare team, and all treatment options will be offered to you regardless of whether or not you participate in clinical trials.
You will never be penalized for deciding not to participate in a clinical trial. It is entirely your choice.
You must do what is best for you.

I'll do whatever the doctor says. (Not a question but a statement often made.)

The doctor has given you all of your choices. The doctor does not know if the new treatment being offered in the clinical trial is better or not. 
If the doctor discussed the study with you, he/she must think it is one of your treatment choices. 
It is always your decision. The doctor can't make this decision for you.

Who will have access to my files?

The doctors, nurses, and other health care professionals working at the cancer centre. The people who organize the clinical trial will also be given some information about you, but not your name. They will be given your initials and a file number for your results.  Keeping your information private and confidential is very important. There are rules and laws to protect you and your private information. 
For safety reasons, sometimes files are reviewed to make sure the rules are being followed.

Would I ever find out what treatment I was on if the study was a "blinded study"?

For many trials everybody (patient, doctor, nurse) knows what treatment the patient is receiving. 

There are some studies that are ‘blinded’ where neither the doctor nor the patient knows what treatment that patient is getting. Blinded studies are done to make sure that everyone on the study is treated in exactly the same way. For blinded studies, someone keeps track of which patient is getting what treatment but they are not allowed to tell except under very special conditions.   

Examples of these are: a) if you are experiencing a serious side-effect and the doctors need to know the treatment you are on, b) if your cancer gets worse and knowing which treatment you were receiving will affect the decision of which treatment to give you now.

Will I find out the results of the study?

Determining the results of a clinical trial sometimes takes a long time. When the results of the trial are available, your doctor will inform you of the results. However, it often takes many years to determine the results of a study. Continue to ask your doctor if the results are available, and, if not, when you can expect them.

The following websites give the results of some clinical trials:
National Cancer Institute (US) 
Canadian Cancer Society 
Children's Oncology Group 
National Cancer Institute of Canada 

How many people are already on the study (both at this Centre or the study as a whole)?

The answer to this will depend on the type of study and how many different centres are participating in it. Your doctor or clinical research associate will know how many people are expected to be on the study.

What happens if I have problems on the trial?

When you agree to participate in a clinical trial, the problems that might happen will be discussed with you. You will be told what to do for each type of problem. 

You will also be given the same emergency contact information that everyone receives so you will have the support of the cancer centre for any urgent problems arising.

I heard that doctors get paid to recruit patients for clinical trials. How do I know that the doctor really has my best interests in mind, and isn't trying to make money off me?

Doctors are not paid, and receive no extra salary or benefits for recruiting patients to cancer clinical trials. In fact, recruiting patients for clinical trials makes a lot of extra work for doctors above and beyond their usual workload. All cancer doctors are very aware of the need to improve cancer therapies and donate their time and energies to make sure patients in Nova Scotia can benefit from the same types of research and treatments as patients anywhere else in the world.

All clinical trials offered at the Cape Breton Cancer Centre, the Capital Health (Queen Elizabeth II Health Sciences Centre) and the IWK Health Centre must be reviewed by a Research Ethics Board to make sure that the trials consider the best interests of patients.

All approved clinical trials must pass a rigorous series of evaluations to ensure the highest ethical standards are met focusing on patient care.

I'm afraid you are going to use me as a guinea pig.

We know that your safety is very important to you. It is important to us too. There are many steps that must be taken to make sure the drug or therapy is as safe as possible before it is offered to patients. 

All clinical trials offered at the Cape Breton Cancer Centre, the Capital Health (Queen Elizabeth Health Sciences Centre) and the IWK Health Centre must be reviewed by a Research Ethics Board to make sure that the trials consider the best interests of patients. 

For each clinical trial, there is a committee that looks after patient safety. They review the results of the trial and can stop the trial early if there is evidence that the new drug or therapy isn't working and is harming patients.

Clinical Trials
More information on clinical trials available in Nova Scotia is available from the Canadian Cancer Trials website.