Before a new intervention (e.g.: a medication or a treatment plan) can be integrated into clinical practice, researchers have to make sure that it is safe and useful. Testing consists of four stages. Stage III of testing is usually a Clinical Trial. This is a large study involving thousands of patients with the disease. Clinical Trials may compare the new intervention (Drug X) to:
- Drug X versus placebo
- Drug X versus Drug Y
- Drug X versus Standard Drug
Patients must fit a set of parameters called the “eligibility criteria” to consider participating in a Clinical Trial. In cancer trials, these criteria often describe a certain location and stage of the disease. If someone is eligible and agrees to join the trial, they are randomly assigned to a treatment group. This is very important, because it means that not everyone receives the same treatment. A lot of the time, patients (and potentially even their doctor) will not be told which treatment they are receiving. This is called “blinding” and it is done to minimize bias and make sure the results of the experiment are accurate.
Successful Clinical Trials are a the best form of evidence to determine appropriate treatments. They are the Gold Standard in science! The results of a Clinical Trial can help researchers determine if a new treatment is better, worse or the same at achieving a particular goal compared to the control drug or placebo.
Participating in Clinical Trials can potentially give patients access to treatment with new or otherwise unavailable medications or treatment routines. It is also an excellent way to contribute to research, so that the medical community can continue to develop better ways to help gastric cancer patients.
Clinical Trial Story:
DISCLAIMER: the following story is fictionalized and meant to explain the general process of enrolling in an oncology clinical trial; it in no way represents a specific patient experience.
Carrie is an advanced gastric cancer patient who has has been diagnosed with a T3 tumor in the distal region of her stomach. She is not eligible for gastrectomy surgery. Carrie has been treated with chemotherapy for the past several months since her diagnosis. However, she does not seem to notice any relief of her symptoms and would like the chance at another treatment. Carrie’s son tells her that it might be possible to enrol in a Clinical Trial, which represents the final stage of quality-testing for a new medicine or treatment plan before it becomes prescribed by doctors. Carrie learns that the treatments being tested in a Clinical Trial have already passed through many stages of intense testing to make sure they are safe. She agrees with her son that this could be a good option for her.
The purpose of a Clinical Trial is to find out if a new treatment is truly better than the standard options which are currently being used to treat patients. So, they often follow a randomized design. This means that patients are randomly assigned to one of the comparable treatment groups. Only one group will actually receive the new treatment, and usually patients are not told which medicine they are taking (which is known as “blinding”). After learning this information, Carrie is still interested in participating in a Clinical Trial even though she knows she is not guaranteed to receive the new chemotherapy.
Carrie speaks with her doctor about Clinical Trials happening nearby. She learns that a hospital in her city is currently recruiting patients for a trial which compares the old chemotherapy Carrie is currently using, to a new routine. Thankfully, her characteristics (age, cancer diagnosis, previous treatment, etc.) fit the trial eligibility criteria. Carrie is able to get in contact with the local Trial Coordinator using a referral form from her doctor.
This individual gives Carrie more information about the trial and guides her through the consent process. The Trial Coordinator sits down with Carrie and explains what the Trial is trying to accomplish, the commitment and timeline required from participants, as well as potential side effects of the treatment. Carrie correctly understands that she is not obligated to participate, and that she should only say “yes” after thinking about her choices. Also, Carrie knows that if she does decide to participate, she can withdraw consent (drop out of the trial) at any time. Feeling a little overwhelmed, Carrie takes the information she was given home to discuss with her family. She also goes to see her Family Doctor to ask for his advice and takes some time to think it over. Eventually, Carrie decides that she does want to participate in the Trial, and gives the Coordinator a call back.
The Consent Process:
The process of “obtaining informed consent” in Clinical Trials is extremely important! This means: a) the patient fully understands the Trial and their role in it, b) the patient knows about the potential risks and benefits of participating, c) the patient understands that they can choose to stop participating at any time, and d) they give their signature as a participant.
Informed consent begins with a conversation between the researcher and the patient. Carrie had talked to the Trial Coordinator and after taking some time to think about her options and get some advice, she decided to give consent! When she calls the Trial Coordinator and lets them know she has decided to participate, she schedules an appointment at her treatment centre for the baseline visit. When she goes and meets with the Trial Coordinator the next time, she signs the consent paperwork and allows researchers to collect some of her information. They record her height, weight and a blood sample. She also fills out a few surveys about her lifestyle, symptoms, gastric cancer diagnosis and past treatment.
After deciding to give consent, Carrie is enrolled in the trial and begins treatment. She attends regular check-up visits at the hospital to allow the researchers to collect data. At these appointments, she typically provides a blood sample, has a CT scan and answers questions about her lifestyle and coping with her cancer. Because this is a Randomized Controlled Trial, Carrie will not find out which chemotherapy routine she is actually receiving. There is no guarantee that by joining the Trial she will receive better treatment than the medication she was taking before.
Although the details of each Clinical Trial are different, Carrie’s story is representative of many cancer patients who may register for a Clinical Trial especially after given a diagnosis of advanced gastric cancer.