Clinical Trials

• What is a Clinical Trial
• Why are Clinical Trials Important?
• Benefits of Clinical Trials
• Risks of Clinical Trials
• How to Find a Clinical Trial
• Where are Canadian Clinical Trials Located?
• What to Know Before Joining a Clinical Trial
• Cost of Participating
• Where Your Treatment and Testing will occur
• The Clinical Trial Team
• Informed Consent 
• Questions to Ask Your Clinical Trial Team Before Starting

 What is a Clinical Trial

The purpose of most clinical trials is to answer specific questions about new therapies or new ways to use existing therapies to treat a disease. Clinical trials, also referred to as research studies, are conducted under strict Canadian regulations and lead by clinical hematologists and oncologists who are specially trained in the treatment for cancer. Clinical trials can also exist for other types of diseases, and are not specific to just cancer patients.

A clinical trial is a type of research study where new treatments are tested on patients, or existing treatments are tested in new populations of patients. A clinical trial will assess many aspects of a treatment or combinations of treatments, including the safety and efficacy of the therapy by itself and/or in comparison to standard treatments, as well as potential new methods of administering treatments.

The protocol (design) of a clinical trial is examined and approved by ethics committees and must meet rigorous government and medical standards. A significant amount of careful, detailed research is conducted on the new medication before it reaches the stage where it is tested on patients. There are different types of trials in which a patient may participate. They are listed in the following table:

 Why are Clinical Trials Important

Clinical studies are important for several reasons. They are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:

• Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
• Finding ways to prevent the development or relapse of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches
• Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
• Examining methods for identifying a condition or the risk factors for that condition
• Exploring and measuring ways to improve the comfort and quality of life through supportive care for patients with a chronic illness

 Benefits of Clinical Trials

Participating in clinical trials can provide potential benefit to patients directly and to those with similar conditions in numerous ways. Some of these benefits can be seen below:

• Access for patients to promising new treatments often not available outside the clinical-trial setting
• Access to treatment that may be more effective than the standard approach
• Close monitoring, advice, care, and support by a research team of doctors and other health care professionals who understand your disease or condition
• The opportunity to be the first to benefit from a new method under study
• The chance to play an active role in your own healthcare and gain a greater understanding of your disease or condition
• The chance to help others within the lymphoma community by contributing to medical research. Even if you do not directly benefit from the results of the clinical trial you take part in, the information gathered can provide future treatment options for patients and contributes to scientific knowledge in the field.

 Risks of Clinical Trials

For an experimental treatment to be given to patients, it must gone through rigorous testing and validation studies before being approved by Health Canada for testing in the humans. Despite this, as it may be the first time a treatment is being tested in humans, there are potential risks that individuals should be aware of before participating in a clinical trial. These risks include:

• The treatment may result in some toxicity, and as such you may experience mild to severe treatment-related side effects
  • You may experience a side effect that is not predicted to occur
  • You may require medication or hospitalization to treated your side effect
• The treatment may prove less effective than standard therapies and offer little or no benefit
• You may be in the control group of the clinical trial, and as such may receive a standard therapy and not the experimental drug; however, you are still receiving the best care available for your lymphoma
• The clinical trial may impact your quality of life and could cause some inconvenience in terms of the frequency of treatments or assessments required

 How to Find Clinical Trials

Clinical trials are conducted across the world at different hospitals and cancer centers. One clinical trial for a certain drug in a certain patient population may be open at multiple centres across the world. In other instances, a clinical trial may be conducted only within one region of a country. There is a rapid turnover of clinical trials meaning new trials become available while existing trials close on an ongoing basis. It is important to understand the status of a trial while looking for one to join. The status of a trial could be:

• Not Yet Recruiting: the study has not started recruiting participants, but soon will.
• Recruiting: the study is currently recruiting participants
• Enrolling by invitation: the study is selecting its participants from a population or group of people, decided on by the researchers in advance. These studies are therefore not open to everyone who meets the eligibility criteria.
• Active, not recruiting: the study is ongoing, and participants are receiving an intervention or being assessed, but the study is not currently recruiting new participants
• Suspended: the study has stopped early but may start again
• Terminated: the study has stopped early and will not start again. Participants are not longer be treated or assessed
• Completed: The study has ended normally, and participants are no longer being examined or treated
• Withdrawn: the study stopped early before enrolling its first participant.

There are many ways to find out about a clinical trial in your region. Healthcare providers may be able to tell their patients about clinical trials or provide referrals if necessary. Comprehensive cancer centers and their websites may also have information about clinical trials for different types of lymphoma. When looking for a clinical trial, it is essential to know the details of your illness. This includes knowing your exact diagnosis, stage, treatment history, and other illnesses that could affect your eligibility to enroll in a trial. Each clinical trial has strict eligibility criteria which may be dependent on age and fitness level, diagnosis (i.e. lymphoma subtype), pre-existing conditions, blood count levels, or prior treatments. Therefore, it is important to speak with your doctor about your eligibility for a clinical trial.

The information/resources below can help you locate clinical trials in Canada:

 Where are Canadian Clinical Trials Located?

Clinical trials are generally conducted at cancer centers, universities, hospitals, or clinics that have the required equipment as well as trained clinical research staff to support the clinical research being conducted. The location usually depends on the design of the clinical trial and treatment and care required. Below is a list of different centres across Canada where lymphoma clinical trials are commonly being conducted:

 What to Know Before Joining a Clinical Trial

Before you decide to join a clinical trial, you need to understand the protocol. A protocol is a written description of the trial. It explains why the trial is being done, how it will be conducted, and how your safety will be ensured. The protocol will also include information on:

• who can participate in the trial (eligibility)
• how many people will take part in the trial
• what type of treatment will be given and how often
• what medical tests you will have during the trial and how often
• how long the trial is expected to last
• how the researchers will know if a treatment is working
• what type of information will be collected and how the information will be analyzed

 Cost of Participating in a Trial

In most cancer treatment trials in Canada, your provincial health insurance plan or the group sponsoring the study will cover the cost of care, medicine and testing. But it is a good idea to ask the clinical trial team about possible extra costs or expenses and whether these are covered. These might include the cost of getting to the treatment centre or medicine to treat side effects of treatment, such as anti-nausea drugs.

 Where your Treatment and Testing will Occur

A clinical trial usually takes place in the same location where standard cancer treatment is given – cancer centres, hospitals, clinics or doctors’ offices. If you live in a small town or rural area, you may need to travel to a larger city to participate in the trial and take follow-up tests. Further, some testing like local lab work may be able to be perfomed at a local clinic, while treatment is administered through the hospital. Additionally, some treatments may involve oral administration where you do not need to go to a hospital. Hence, it is important to ask questions regarding the expectations of patients regarding travel, treatment administration, and frequency of appointments, when deciding to participate in a clinical trial to ensure that you can manage these requirements.

 The Clinical Trial Team

Clinical trial teams are made up of doctors, nurses, pharmacists, research assistants and other healthcare professionals who are trained in clinical medicine and in the proper conduct of clinical trial research. The person in charge of the clinical trial, often an oncologist, is called the principal investigator. It is important to be familiar with the clinical trial team who are there to help support you throughout your treatment and care. Ensure you know who to contact to answer your questions related to trial participation, and who to share your concerns with regarding your monitoring and caring for your health during the trial.

 Informed Consent

You should be given all the appropriate information about a clinical trial before you decide to take part. You should also be provided the opportunity to ask and have answered all of your questions related to trial participation. This important process is known as informed consent. Patients interested in taking part in the study will receive a consent form that outlines key facts about the study. These include details about the treatments and tests, as well as any potential benefits, risks or side effects. If you agree to take part, you will be asked to sign the informed consent form. No patient should feel pressured to participate in a clinical trial. Hence, even after you have signed an informed consent form, you have the ability to withdraw from participating in a clinical trial at any time. Leaving a trial will in no way affect the care you will receive from your medical team, and you will still receive the best current standard treatment for your lymphoma.

 Questions to Ask Your Clinical Trial Team Before Starting

Choosing to be part of a clinical trial is a very important personal decision. It is very important for you to ask questions before starting a trial to help you decide if this is the right option for you. Asking questions can also help you feel more confident with your decision to proceed or reject participating in a clinical trial. Do not be afraid to ask for clarification if you do not understand something. Some useful questions to ask the clinical trial team before starting a clinical trial can include:

1. What is the purpose of this clinical trial? What are the primary or secondary objectives of this trial?
2. Why are you recommending this specific clinical trial for me? How do you think I will benefit from joining this clinical trial?
3. Has this type of treatment (or combination of treatments) ever been tested in humans before?
4. Will I receive the new investigative therapy if I enroll in this trial?
5. What are the benefits and risks of participating?
   1. What are the possible side effects of the study treatment or approach?
   2. How do these side effects compare with standard treatments or approaches?
6. What types of medical tests, procedures or treatments are done during throughout my participation in this study? How frequently are they administered?
7. How often and for how long is the study treatment given?
8. What are my responsibilities throughout my participation in this clinical trial?
9. When will we know if the treatment is working and how will this be confirmed?
   1. If the treatment is not working, will I be removed from the trial?
10. Are there any activities or other treatments that I cannot take during my enrollment in this trial?
11. Who do I contact if I have any questions during the trial? Who do I contact regarding any health concerns or side effects I experience during the trial?
12. What happens if my health gets worse at any point during the trial? What do I do and whom do I contact?
13. Will my participation in this trial require any out of pocket expenses? Can I still work or participate in daily activities throughout the trial?
14. Where will the clinical trial and all tests involved be conducted? Are travel costs and expenses covered?
15. Can I speak with other people who have been enrolled in the trial before me or have received this treatment before to learn about their experience?
16. Are there any consequences for dropping out of the trial at any point?
17. What happens when the clinical trial is completed? Will the results be shared with me?
18. How will my information and privacy be protected throughout the clinical trial?
19. Will there be any follow-up procedures and tests after I complete treatment? For how long will follow-up care occur for?

Many of these questions may be answered through the informed consent form you will receive outlining important details for your participation in the trial.