Whether you’ve recently received a cancer diagnosis or have been navigating this condition for an extended period, there may come a moment in your treatment journey when your doctor says, “I believe there’s a promising clinical trial opportunity available for you.”
The choice to participate in a clinical trial may sound scary or it may sound exciting but if you are considering it, the real question is what happens next? Below I will help you navigate through the process of getting onto a clinical trial by answering some of the questions that I get from patients who are going through this process.
How do I find out more about this new treatment option?
After your doctor briefly explains the study to you, a member of the research team will come to speak to you about the details of the study. This person is called a Clinical Research Coordinator (CRC). The CRC will bring a copy of the informed consent (ICF) with them and go over the details of the study and answer any questions you may have at that time. You will be encouraged to take the consent form home to read over it and discuss with loved ones. You will be provided with contact information for the CRC in case you have any additional questions that you might not have thought of at the time. The CRC will be your navigator through the entire process. Keep their number handy!! Once you have made a decision, you can reach out to your CRC to schedule time to come in and sign the ICF, in person.
Why is the informed consent so many pages?
The information you are provided by the CRC may seem overwhelming. You might ask yourself why is this consent form is so long? FDA guidance states that all research consents should include several key elements to ensure the participant is fully informed of their rights and responsibilities.
The ICF should include all of these key elements:
- Study Purpose: A clear and concise explanation of the research study’s purpose, objectives, and goals.
- Study Procedures: A detailed description of the procedures, tests, or interventions involved in the study, including how they will be conducted, the expected duration, and any potential discomfort or risks.
- Voluntary Participation: A statement emphasizing that participation is entirely voluntary, and participants have the right to withdraw at any time without penalty.
- Benefits and Risks: A discussion of the potential benefits of participating in the study, as well as any known or foreseeable risks, side effects, or discomforts associated with the study procedures.
- Confidentiality: An assurance that participant data will be kept confidential and that identifying information will not be disclosed without explicit consent, except as required by law.
- Compensation or Costs: Information about any compensation or reimbursement for participation, as well as any costs or expenses that participants may incur during the study.
- Alternative Options: A discussion of any alternative treatments, procedures, or options available to participants, including the option to receive standard care if applicable.
What does screening mean?
Once you have signed the ICF, your CRC will tell you that you must complete screening procedures. So, what does that mean for you? The CRC has a specific list of assessments that will need to be completed for you to continue with the trial. These tests vary depending on the trial but can include,
- Laboratory assessments
- CT/MRI scans
- Pulmonary function tests
- Cardiac Tests (eg. ECHO/ECG)
- A biopsy
- Clinic visit for: Physical exam/Vital signs/Medical history review/Medication review
How will I know if I am qualified for the trial?
Once you have completed all the screening assessments your CRC might say that they now need to review eligibility. So, what does that mean? For patients to receive treatment on a clinical trial, they must meet all the required criteria set forth by the sponsor (e.g., The drug manufacturer). For the CRC, this is a list of yes or no questions that must be answered about the patient to ensure they are fit and appropriate for that specific trial.
To address all these inquiries, it is essential to conduct a comprehensive examination of your medical records and the outcomes of your screening assessments. Additionally, during your clinic visit, a thorough inquiry into your current medical history and medication regimen may be necessary.
This information will be put together into a package which is reviewed with your study doctor and sometimes the sponsor for confirmation of eligibility.
But I need treatment now, so how long is all of this going to take?
The consenting, screening and eligibility process can take anywhere from 1-4 weeks, but every effort is made to get the patient on a quickly as possible. Most patients are starting treatment in about 2 weeks.
Will this work for me?
The primary goal of a clinical trial is to assess the safety and effectiveness of a drug for your specific disease type. Often, there may be limited existing data to predict individual responses to this treatment, which is why the trial is being conducted. In cases where the study involves both an FDA-approved therapy and an investigational one, your study doctor can provide information about the known effectiveness of the approved drug.
During the trial, a specific set of tests and assessments, as defined by the study sponsor, will be conducted at designated time points while you are enrolled. These assessments may include various tests such as scans, laboratory tests, physical exams, and others. The purpose of these assessments is to thoroughly evaluate the safety and effectiveness of the drug being studied.
What are the side effects?
The side effects experienced by participants in a clinical trial can vary widely depending on the specific trial, the investigational treatment or intervention being tested, and individual patient characteristics.
It’s important to note that not all participants in a clinical trial will experience side effects, and for some, the side effects may be mild or manageable. Others may experience more severe side effects. The goal of clinical trials is to assess the safety and efficacy of new treatments, and researchers closely monitor and manage side effects to ensure participant safety.
Finally, it’s time for treatment, what do I do now?
You made it through the process and now it’s time for treatment. Once you start your treatment its vital that you inform your CRC if you have any new side effects, any changes to your medications, and any hospitalizations. Knowing this information is important to your study doctor so that they can manage any side effects urgently and determine if there are any safety concerns about the medication you are taking that need to be reported to the sponsor. It is also important to make sure you tell your CRC right away if you will not be able to make it to your appointments or if you need to reschedule.
About the author
Karin Donaldson is our senior research coordinator for the Solid Tumor Cellular Therapy/Phase 1 clinical trial sections and she shares details of a new protocol we have just opened. We are the first site in the country to now be site activated for this protocol and this includes ANY solid tumor patient with an accessible lesion to be considered if progressive disease beyond standard of care. Further details of the study can be found here. Enjoy!