Clinical Trials

The purpose of most clinical trials is to answer specific questions about new therapies or new ways to use known therapies in the treatment of disease. All clinical trials follow extensive laboratory research prior to testing in humans. These clinical trials, also referred to as research studies, are used to determine whether new therapies are both safe and effective. Clinical trials are conducted under strict Canadian regulations and lead by clinical hematologists and oncologists who are specially trained in the treatment for cancer.

What is a Clinical Trial?

A clinical trial is a type of study where disease treatments are tested on patients. A clinical trial can test many aspects of treatment, including the safety and effectiveness of new medications, the addition of new medications to standard treatments and potential new methods of administering standard treatments. Trials usually compare a new treatment with a standard treatment. These trials are called randomized controlled trials. In these trials, half the patients receive the new treatment and half receive the standard treatment. This is why the trial is called controlled, as the new treatment is compared with treatment whose effects are already known. A computer determines which patient receives which treatment to ensure that the comparison is truly objective and not biased. This is the process of randomization and hence the term randomized trial. If the doctors who treat the patients were to decide who receives the new treatment and who does not, they might be biased towards choosing the sickest patients to receive the new treatment, making the results less accurate and less reliable for the future.

The protocol 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:

Trial Type      Major Differences
Phase I
  • Tests for safety and appropriate dose of a new treatment (does not compare it with another treatment)
  • Increased risk of side effects
  • Usually includes only a small number of patients who often have advanced disease that has not responded to current treatments
Phase II
  • Tests for side effects and efficacy of new treatment (does not compare it with another treatment)
  • Larger number of patients than a phase I trial
Phase III
  • Further tests the new treatment on large numbers of patients once the phase II trial has shown the treatment to be effective and safe
  • The new treatment is compared with a standard treatment to determine if the outcome is more beneficial for patients (randomized controlled trial)
Phase IV
  • Further study of the treatment after the treatment has been licensed for use in standard practice

 

What are the Benefits of Participating in a Clinical Trial?

Experimental treatments are not available to patients outside of a clinical trial. For a treatment to be given to patients, it must have been rigorously studied and tested, and must be approved by Health Canada. The main benefit of participating in a clinical trial is that patients can receive new treatments that are not yet on the market. If a patient has received the standard therapy for their particular type of NHL and has not achieved the desired response, a clinical trial may be a good option.

What are the Risks Associated with Participating in a Clinical Trial?

You should be aware of the risks before participating in a clinical trial. They include:

  • The treatment may be toxic such that you may experiences severe side effects.
  • 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 NHL therapy and not the experimental drug.

Patients who choose to take part in a clinical trial must give informed consent. This means that they are aware of the potential benefits and associated risks and that they are a willing participant. No patient should be forced or pressured into participating in a clinical trial. Furthermore, once a patient is in a trial they have the right to leave the trial at any time without explanation. Leaving a trial will in no way affect the attitude of your healthcare team, and you will still receive the best current standard treatments.

Choosing to be part of a clinical trial is a very important personal decision. Discussing therapies being researched and the possibility of being part of a clinical trial for treatment of your lymphoma will help you decide if this is the right option for you.

New clinical trials become available and existing trials close on an ongoing basis. In addition to the information contained on this Web site please visit www.clinicaltrials.gov for a comprehensive listing of trials being conducted in Canada or you can visit the National Clinical Trials Group at www.ctg.queensu.ca for what is happening there in lymphoma. (Not enough by the way, send a letter in and ask for more lymphoma research!) In Ontario you can check with the Ontario Institute for Cancer Research.