While everyone’s cancer clinical trial experience is unique, here are some things you might encounter along the way.
Every clinical trial is overseen by an independent committee called an IRB, that approves, monitors, and reviews how a study is run. The IRB’s primary objective is to protect the interests and welfare of you, the patient participating in a clinical trial. They also ensure participant confidentiality and privacy.
IRBs serve as watchful guardians of participant safety, operating independently of the organization which is funding the study. These federally-regulated panels are made up of doctors, scientists, and at least one nonscientist.
A critical element of any trial is the participants. The IRB makes sure a trial has the right mix of participants and that they are participating voluntarily and without any undue pressure. One of the key functions of the IRB is to review the Informed Consent document to help ensure participants can understand why a trial is being conducted and what to expect along the way.
The IRB also makes sure the trial is designed in such a way that it will effectively answer the key scientific questions. In fact, no trial can begin until it’s approved by the IRB. Ultimately, the IRB has the power to require changes to a study or even reject it outright—all in an effort to ensure the safety and rights of the trial participants.
A large team of people work together to ensure your safety and the quality of your care. You’ll meet some of them on your trial journey but many of them work behind the scenes.
This is the researcher who had the idea for the trial and designed the way the trial works. The principal investigator manages the trial all the way through to the end, helping to gather, analyze and present the findings.
Depending on the trial and institution, the exact title of this role may vary. The research nurse will guide you through a detailed “Informed Consent” document, manage the day-to-day aspects of the trial and serves as the go-between for the PI and the doctors and patients in the trial. If you participate in a trial, you will likely find that the person in this role is your main contact to help guide you through the whole process.
You will generally meet with the research nurse at every appointment, regardless of why you’re there. The research nurse can help coordinate your scheduling to minimize trips to the treatment center, keep you well informed, and can let you know when a test or exam is specific to the trial and not standard treatment.
This nurse provides hands-on care and tracks how patients are doing. Depending upon the type of trial, this may include a medical oncology nurse as well as a radiation oncology nurse.
The physician also provides hands-on care and serves as your treating physician. For larger trials run at many institutions simultaneously, your regular oncologist may serve this role. You will have regular meetings with this doctor to go over your latest test results.
The person who draws your blood.
The advocate understands your needs because they have been where you are now. They are a highly respected member of the research team, providing input and suggestions on various aspects of the trial from the perspective of a patient. They consider things like costs incurred, eligibility requirements, frequency of scans or biopsies, and why someone would want to participate in the trial.
A social worker is available to answer questions, help you find support, and point you to resources that can make your journey easier for you and your loved ones.
Depending on your type of cancer, you may see a specialist as part of your overall care.
Surgeons get involved depending upon the type of cancer and the biopsy/surgical requirements of the trial.
Depending upon the type of trial and whether radiation is involved, you may work with a radiation oncologist as well.
They can work with the research nurse to help you get through all the testing and exams of the trial according to the timetable defined by the researchers. They can also work with you to combine appointments and limit the number of visits to the study center.
This key member of the team manages the study drugs, preparing them for administration and managing the various medications each participant is taking.
People with cancer – like you – looking for help. The trials cannot run without people like yourself who take the leap in the hope that a trial may benefit them or others who will follow in their shoes.
Each trial will have a different treatment protocol that participants follow as outlined in the informed consent document. Before you start treatment, it’s important to understand your rights, responsibilities and also any financial implications for participating in a trial.
By participating in a cancer clinical trial, you’re likely to have more tests than you would receive if you weren’t in the trial. These may include blood tests and other lab tests, x-rays, scans, and biopsies.
By participating in a cancer clinical trial, you’re likely to have more tests than you would receive if you weren’t in the trial. These may include blood tests and other lab tests, x-rays, scans, and biopsies.
Biopsies
While blood tests and scans can provide a sense of how someone is doing, nothing tells the story of a person’s cancer better than their own cancerous tissue. Biopsies let researchers look directly at a cancer. That’s how genetic mutations and other features of a tumor can be discovered. Looking at tissue samples, researchers can see information about the tumor that can be used to defeat the cancer.
Cancer treatments are becoming more and more sophisticated, often targeting specific mutations or finding biomarkers that can be used to target treatments. So tissue samples are often required to find out whether the tumor of a trial participant has the traits that the study drug is designed to treat.
Although you may have already had a biopsy prior to joining a trial, you may need to have a biopsy specifically for the purposes of the trial. In addition, you may be asked to undergo a series of biopsies during the trial to help researchers see how you are responding to the therapy at the cellular and molecular levels. Your willingness to provide biopsies is vital to understanding the science behind the cancer.
The study drug is provided free of charge. Any special tests done specifically for the trial, such as extra blood tests, are typically paid for by those running the trial. Other costs associated with your care are handled as they would be if you weren’t in a trial.
The study drug is provided free of charge. Any special tests done specifically for the trial, such as extra blood tests, are typically paid for by those running the trial. Other costs associated with your care are handled as they would be if you weren’t in a trial.
The study center may have a financial navigator or social worker who can answer your questions and give you suggestions or access to resources that may be of help. Your doctor and their office staff can direct you to a variety of helpful resources to support you on your cancer journey.
While a biopsy can provide valuable information about how your tumor is responding today, the boundaries of our current knowledge limit what researchers can evaluate and glean from your tissue sample. But that won’t always be the case.
While a biopsy can provide valuable information about how your tumor is responding today, the boundaries of our current knowledge limit what researchers can evaluate and glean from your tissue sample. But that won’t always be the case. As science advances, so too does our understanding of what we see under the microscope…and in DNA.
Serial biopsies are a set of biopsies taken at different times during the course of therapy. A series of biopsies provides insight on whether a treatment is working and how the cancer changes in response to the therapy. Often, this is some of the most valuable data collected during a clinical trial.
It’s important to know that maintaining your privacy is a top priority. You can restrict access to specific researchers or organizations. And contributing to a tissue bank will not impact things like your children’s ability to secure health insurance.
You may be asked for your permission to bank your tissue samples so that more information might one day be gathered from them. As science progresses, researchers can then pull up older biopsies for further study.
Science is progressing so rapidly, tissue banking affords us the opportunity to study more cancers more rapidly.
While some people are open to scientists using their cancer cells for any research that might save anybody’s life at any time, other people may want to be more restrictive. There are protections in place for both instances.
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