There are several different options pancreatic cancer patients have when it comes to treatment plans. While clinical trials aren’t always the first option that comes to mind, it is a good path to take if you are looking to try a new type of treatment, or are finding that other treatments just aren’t working for you. So let’s dive into the ins and outs of clinical trials and how to go about finding one that fits your needs.
Working with Clinical Trials
Clinical trials are medical research studies designed to test out possible new medications or treatments for specific medical ailments. According to The National Heart, Lung, and Blood Institute, most clinical trials are heavily researched and tested in the laboratory to ensure that they are safe to test on humans.
Before searching for any clinical trial, please discuss the decision with your doctor. As a member of your healthcare team, they need to be notified of any treatment methods you are taking. Your healthcare team also has the best resources to help you begin looking for a clinical trial. Cancer Support Community suggests that you ask your doctor about joining a clinical trial early on in your treatment process, however, you can bring up a conversation about clinical trials at any point during your diagnosis.
However, if you are going to begin searching for clinical trials on your own, there are a few things you should make sure to pay attention to. According to Cancer Support Community, it is essential that you know your cancer type and stage before searching for trials. They also suggest making a list of previous treatments/ procedures you’ve gone through and what locations you are willing to travel to for trials.
While looking for clinical trials, it is important to understand the different types of trials available to you and how they work, so you can pick the best one that works for you and your diagnosis.
Types of Clinical Trials
Cancer Research UK states that there are two types of clinical trials: interventional and observational. An interventional study looks to find out more about a certain type of medication or treatment, while an observational study aims at what happens to different types of patients when given the same treatment or medication. Within these two categories, there are several different types of research methods professionals may choose to explore a new treatment option.
There are several different types of interventional studies. A pilot or feasibility study is done to determine if the trial can be performed on a larger scale. A feasibility study mainly tests interest in the medication, whereas the pilot study dives into every aspect of the trial to ensure that it will be successful. Think of it as sort of a phase negative one of a trial. After these preliminary studies, researchers will move into other types of trials including treatment trials, which work directly in phases to test the medication or treatment in question. Multi-arm multi-stage (MAMS) trials are trials that include multiple treatment groups and a control group. It’s essentially a larger-scale treatment study that investigates several different treatments at once.
Prevention and Screening trials are another form of interventional studies. However, they look at people who do not have pancreatic cancer currently. Prevention studies test to see whether the treatment in question can prevent pancreatic cancer, whereas a screening trial looks at whether certain tests are reliable for predicting pancreatic cancer and determining possible markers. An example of a screening study is the PRECEDE study aimed at testing patients with a BRCA-2 gene mutation for pancreatic cancer. To learn more about this study, please read the article on our blog.
There are three main types of observational studies; cohort, case-control, and cross-sectional studies. According to Cancer Research UK, a cohort study is a type of trial that looks at one group of people over a period of time and is typically used to determine potential risk factors with the treatment. Case-control studies take persons with pancreatic cancer and those without and determine whether or not they have been exposed to the risk factor the study is looking at. This could be a type of chemical, food, etc. Cross-sectional studies examine a short period of time and look to see who has been exposed to the risk factor in question and then see if those people have developed pancreatic cancer.
Each form of study has its own pros and cons; however, clinical trials overall give patients a chance to test out new treatment options and potentially create positive change in the pancreatic cancer community.
How to Find Clinical Trials
Once you’ve decided which types of trials you would like to participate in, you need to make sure that you use reliable resources to find the right study for you. There are several different government-approved databases for finding reliable clinical trials. We recommend searching through one of the databases suggested below as a starting point for finding verified clinical trials:
- World Health Organization Database
- ClinicialTrials.gov (National Library of Medicine’s database)
- The National Cancer Institute’s Database
What Do I Want to Look For In A Clinical Trial?
When narrowing down what clinical trials you think would be best for you, it is important to look into the details of each study. However, before beginning any clinical trial officially, please inform your healthcare team of your decision and provide them with all the information you have found about the study. This will help you and your healthcare team decide if this is the right trial for you.
The National Cancer Institute recommends finding a protocol summary for each trial you are interested in. They state that the summary should introduce the goal of the trial, which treatments will be tested, and/or what population they aim to study and why. It should also be where you can find information about the trial locations as well. You should also check for other criteria regarding the length of the trial and its general procedures.
Patients should know that there are several phases to clinical trials and that they can join a trial whether it is in its beginning stages or nearing the end of its timeline. Each phase in a clinical trial is meant to answer a different question researchers have about the medication. Cancer Research UK states that most trials run in three phases, but sometimes researchers will add in a phase zero and/or phase four.
Phase zero is meant to test whether or not the medication is harmful by giving it to patients in minimal doses. If deemed safe, the trial moves into phase one, where researchers are looking to find the correct dosage, the possible side effects, and how the treatment works in the body. Next, they move to phase two in which they double-check the side effects and dosage and investigate how well the body responds to the medication. Lastly, phase three allows researchers to compare how well the new medication performs against the leading medication on the market currently. If researchers choose to include a phase four, it is typically used to find out what the long-term benefits/side effects of the treatment are.
According to The National Heart, Lung, and Blood Institute, with each phase, the number of participants increases. Therefore a prospective patient looking to get into a clinical trial should be wary of what phase the trial is in, as it may be more difficult to get into earlier phases of a trial. According to The National Heart, Lung, and Blood Institute, patients should also be aware that trials can be randomized, which means that they will be randomly placed into one of two treatment groups. This is done to prevent bias and ensure accurate trial results. Typically, a phase three trial is randomized, though sometimes a phase two trial can be as well.
Patients should also be aware that every clinical trial will come with its own rules about who can and cannot participate in their study. According to The National Kidney Foundation, these guidelines are also known as eligibility. They state that eligibility might be based on several factors including the patient’s age, gender, overall health, type and stage of a disease, treatment history, and other conditions. People can be turned away for any of these factors. Please be sure to check the eligibility requirements of a clinical trial before proceeding with further research.
Lastly, be sure you are looking to see what the objective of the study is. The National Cancer Institute states that some studies may be inserted in testing out curative treatments, while others might be more focused on lessening the severity of symptoms. Patients should be sure that the objective of the study lines up with their expectations for the clinical trial to avoid any confusion.
Once you have agreed to participate in a clinical trial, the National Kidney Foundation states that all trials must also get informed consent from the patient. Patients will be informed of the possible risks, benefits, and other alternatives to this study, such as other treatment options. You will likely be given different types of documents that inform you about the study and the research process, which gives you time to ask any follow-up questions before beginning the trial. According to the National Kidney Foundation, at the end of the introductory process, you will likely be asked to sign a document of some kind stating that you understand the information you have been given and are willing to proceed with the study. Know that you can withdraw from the study at any time, the document is simply meant to be a precautionary measure to make sure you understand the parameters of the study; it is not a contract.
Overall, choosing a clinical trial should be a team effort!
Joining a clinical trial is just one of many care plans patients can explore when choosing which treatment will work best for them. Take your time to explore all your options, including any clinical trial you are interested in, and know that no matter what, your health comes first. Do what feels best for you!