It’s a well-known fact for anyone who has ever tried navigating the world of cancer clinical trials: Finding a research trial that’s a match for you isn’t easy.
The hard truth is that as valuable as clinical trials are in advancing treatment, there’s no single, up-to-date registry of government, nonprofit, drug company, hospital, and academic medical center–funded cancer trials.
“It’s a kind of Wild West out there,” says Andrew Poklepovic, MD, an associate director of clinical research at the Virginia Commonwealth University Massey Comprehensive Cancer Center in Richmond.
What that means is, while doctors and institutions can help, it’s often up to potential participants to at least kick-start the process by scanning a host of websites for trials that seem to be a good fit.
Why bother?
Because clinical trials can be lifesaving.
“I know people alive today because years ago they took as a trial therapy what’s become the standard of care now,” says Dr. Poklepovic. “That’s why I encourage people with cancer or at risk of developing cancer to search widely and often for clinical trials to join.”
Here are 10 steps to help you find a trial that may be a good match:
1. Understand the Types of Trials Available
“There’s a wide variety of clinical trials that together draw on a broad range of people,” says Mark Fleury, PhD, policy principal on emerging science for the American Cancer Society Cancer Action Network. Some trials may want people who need to be treated for a specific stage of cancer, for instance, while others are more interested in preventing cancer in high-risk populations.
Here’s the lowdown on the most common types of trials:
- Prevention trials often recruit people with a high cancer risk to see whether lifestyle changes or other approaches (such as medications, supplements, or vitamins) lower that risk.
- Therapeutic interventional trials test new cancer treatments or treatment techniques, such as devices, medicines, radiation, and surgery.
- Nontherapeutic trials are geared toward observing the cancer without intervention. The goal is to understand the disease and the factors that influence its occurrence.
2. Know Your ‘Performance Status’
This is a measure of how well you function and how mobile you are. Some trials will factor in the kind of shape potential participants are in as part of their criteria for admitting people to trials. There are several ways to classify trials. Here’s a common scale used to show how performance status is determined:
- Category 0: You’re fully active, as you were prediagnosis. You have no symptoms from the cancer.
- Category 1: You are active and can undertake light housework and office work. Strenuous physical activity is challenging, though.
- Category 2: You’re up and about more than half the day. Although you may get tired, you can care for yourself — but can’t work.
- Category 3: You can’t work or fully care for yourself. You’re in a bed or chair more than half the day.
- Category 4: You’re in a bed or chair full-time and can’t care for yourself.
“Most clinical trials accept people in categories 0 and 1, some include 2, while a handful of supportive care trials will draw on category 3,” Poklepovic says.
Why are trials reluctant to admit people in categories 3 and 4? “These people may be too sick or frail to tolerate test treatments or to follow test protocols,” says Poklepovic. Also, the frailer someone is, the harder it is to determine whether that person didn’t do well because of the treatment or because of their physical condition, he says.
3. Decide How Far You’re Willing or Able to Travel
The situation has been worse for Black Americans and other historically marginalized groups, he says, partly because, “Drug companies didn’t base clinical trials in institutions that serve these communities.”
That’s changing as companies and clinicians push to diversify research participation to better ensure results can be applied to broader populations. Some clinical trials may even offer reimbursement for travel and accommodations.
4. Tell Your Doctors You’re Open to Joining Clinical Trials
Many people assume there’s no trial for them if doctors don’t raise the subject. The reality is that not all doctors think to ask, and some might presume — for all kinds of reasons — that you’re not interested. But if you put it on your mutual agenda, your doctor can help advise you on what’s available and guide you regarding the right time to join clinical trials.
5. Find a Health Professional to Help
Beyond your doctor, the best assistance may come from other health professionals at your treatment center, since they’ll know the medical lingo, protocols, and how to fill out a detailed health history form. If you’re not able to find someone at the institution you go to, Poklepovic advises asking a Google-savvy friend or family member (“Teenagers can be great at this”) to search for the nearest academic medical center or cancer practice group, where there is likely someone who can help. You can also contact clinical trial finder services (such as those listed in step 7), many of which provide experienced clinical trial navigators who can guide you through the process.
6. Have Information About Your Overall Health and the Cancer at the Ready
Consider using the National Cancer Institute’s Cancer Details Checklist to help gather all of the specific information about the cancer you have. In addition to performance status, you will at least need to know the type and stage of the cancer to look for a clinical trial relevant to you. The specific name and subtype of the cancer may also be needed to know if you are a good fit.
More recently, clinical trials tend to be open to people with cancers that have a specific molecular expression or mutation. For example, researchers may be looking for breast cancer with HER2-positive expression or lung cancer without the epidermal growth factor receptor (EGFR) mutation.
7. Search Databases
Bookmark or print the protocols and eligibility requirements of studies that interest you. Look locally, regionally, and, depending on your ability and willingness to travel, in other states. Consider checking with reputable advocacy groups or foundations supporting research into the cancer you have, as they may link to trials. Here, too, is a list of well-known databases:
Government-Sponsored Trial Finders
Third-Party Trial Finders
Disease-Specific Trial Finders
8. Check Your Eligibility
Each trial may have very specific eligibility criteria. This will include whether they are looking for a healthy volunteer or someone with a specific condition. They may look at your:
- Age and performance status
- Type and stage of disease, if applicable
- Treatment history — what treatments you have undergone, if any
- Other health problems or conditions, especially if you are taking medication for something else
9. Reach Out to the Trial Team With Detailed Questions About the Study
If you have found a few trials you would like to join but aren’t sure if they’re a good fit, reach out to the trial teams listed for the clinical trials to help you decide. Not sure what to ask? The National Cancer Institute offers an extensive list of questions about, for example, your costs or your rights as a participant. Some other common questions you could ask include:
- What phase is this study in? Phase 1 is the earliest phase and may call for frequent visits, but these trials often offer the latest treatments.
- How long is the wait before I can begin treatment in the clinical trial? You can use this information to plan ahead.
- Are there limited treatment spots? This would affect your waiting time.
- How might the trial affect daily life for me and my family?
10. Schedule an Appointment With the Clinical Trial Team
At this stage, the study team may invite you to come for a screening visit to make sure you are eligible. This may involve a physical exam or additional tests.
You will then receive information about the study’s intent and its risks and benefits. If you are accepted and decide to proceed with the trial, you will be given an informed consent to sign, to show that you have been completely informed of the risks and that you give them permission to treat you.
The Takeaway
- It can be a rewarding experience to participate in a clinical trial. Almost all cancer treatments that are standard today were once available only through a clinical trial. Participating in a clinical trial may not only give you an opportunity to get the best possible treatment, but also help many other people with similar cancers in the future.
- It can be time consuming to access all the information out there about available trials. But there are many resources online you can use to start your search.
- Tell your doctor that you are open to a clinical trial and find out how it might affect your current treatment. Ask your doctor for any relevant medical history, so you have it on hand when you apply for a trial.
- When you find a trial that looks like a good fit, contact the trial’s team with a list of your questions about the risks and benefits of the study.
Read the full article here
