Clinical Trials for cancer treatment development
What are clinical trials all about?
Clinical trials are studies in humans used to determine the safety and efficacy of a novel therapy or a combination of new and/or previously approved therapies.
Did you know?
- Cancer patients in clinical trials are RARELY given a placebo and nothing else. The participants in the control group in most cancer clinical trials receive standard of care (SOC) treatment while the experimental group receives SOC + new treatment or just the new treatment. In other words, you are not left with "no treatment" if you are chosen for the control group (in a double-blind study, neither you nor the researcher would know whether you are in the control or the experimental group).
- You may receive better care while in a clinical trial because you will have another "team" of medical professionals overseeing your treatment, assessing treatment response, monitoring side effects, and ordering labs and imaging for surveillance.
- You can leave a trial at any time for any reason. It's your choice.
- You do not need to give up your medical oncologist to join a clinical trial. The research team is an addition to your care, not a transition from one care provider to another.
- By participating in clinical trials, patients may have access to a potentially life-changing cancer treatment that is not yet available to the general public.
Clinical Trial Acronyms...Decoded
- n= number of study participants
- QoL= quality of life
- HRQoL= health-related quality of life
- PR= partial response (less cancer can be detected after treatment, but it's not gone)
- CR= complete response (no cancer can be detected after treatment)
- RR= response rate (often defined by how many patients experienced a 25% or more reduction in tumor size/overall tumor burden)
- OS= overall survival
- RS= relative survival
- PFS= progression free survival (how long does the patient go before cancer returns, grows larger, spreads, or they pass away?)
- PEP= primary end point
- SEP= secondary end point
- DoR= duration of response
There is more in store for this page so stay tuned! In the meantime, please take advantage of the resource collection at the bottom of this page for more information on understanding clinical trials, searching for clinical trials, and more.
You can also visit our Scientific Studies page for related information.
Do I have to Pay to Participate in a Clinical Trial?
There are costs associated with clinical trials, however they are often paid by trial sponsors (private companies, government funding-NCI/NIH, non-profit organizations). Any balance remaining may be covered by a patient's health insurance or the patient may pay out-of-pocket. What and how much is covered varies from trial to trial, insurance company to insurance company, and patient to patient.
"Patients generally do not have to pay extra out-of-pocket costs for treatments studied as part of a trial. Every trial is different, but the clinical trial’s sponsor usually pays for all research-related costs and any special testing. Typically, the patient or his or her insurance company is asked to pay for any routine tests, treatments, or procedures that would be required as part of standard cancer treatment. Before you join a clinical trial, you will receive an informed consent document that spells out exactly what you’ll have to pay for and what you won’t." (source)
Potential costs associated with clinical trials:
- office/study visits
- blood work and labs
- imaging studies (scans)
- travel to trial site as/if needed
- lodging if traveling out of town for trial participation
- hospital stays and inpatient services
- treatments
- medications
"The costs of care for clinical trial participants fall into two categories — routine care costs and research costs directly related to the clinical trial.
- Routine care costs, also called standard-of-care charges, are those you would incur for treatment of your disease even if you weren’t in a study, as well as costs for monitoring your health or treating complications. These costs may include doctor visits, hospital stays, and lab and imaging tests.
- Research costs are those related specifically to taking part in the study which cannot be billed to your insurance and which are paid for by the study. These costs may include the investigational intervention (such as the drug being tested), extra doctor visits, electrocardiograms or blood draws, and certain lab and imaging tests performed solely for research purposes.
When you take part in a study, you may also incur related personal expenses. For example, you may have extra transportation and childcare costs if you have extra doctor visits that you would not have with standard treatment. You will still be responsible for any copays and deductibles designated by your insurance coverage while on a clinical trial, just like you would for standard care. The study cannot cover copays and deductibles for you." (source)
A study published in Cancer Medicine in April of 2024 by Williams, C. et al., reported the following clinical trial participant survey findings:
- Respondents who experienced trial-related financial hardship were more often unemployed, disabled, Medicare enrolled, and traveled more than 1 hour to their cancer provider.
- Most often reported trial-related expenses were travel (71%), medical bills (58%), dining out (40%), or housing needs (40%).
- 53% of respondents reported needing $200-$1000 per month to compensate for trial-related expenses.
When you speak with a trial coordinator to learn more about a specific trial, they will be able to provide you with details on what your financial responsibility will be for participating in that trial. It may be beneficial to provide supporting information to your insurance company to help justify any related expenses, and this could include data or study results from a similar trial/treatment and/or a letter from your oncologist providing proof of medical necessity for your participation in the trial.
There are some general rules and procedures in place depending on the source of your health insurance as described below.
Individual, Marketplace, and Employer-Sponsored Health Plans
Routine costs (labs, imaging, office visits, etc.) related to participation in a clinical trial must be covered by these types of insurance plans based on Affordable Care Act provisions from 2014.
"Under the Patient Protection and Affordable Care Act (ACA), most health plans must pay routine health care costs for patients who participate in clinical trials for to prevent, detect or treat cancer and other life-threatening conditions. Routine costs include services that the health insurer would cover for a person not in a clinical trial, such as:
- Visits to your doctors' offices
- Laboratory tests
- Drugs associated with standard treatment or supportive care
Health plans are not required to cover visits to out-of-network providers, nor are they required to cover the cost of investigational or experimental treatments (usually provided by the study when you participate in a clinical trial)." (source)
Learn more:
Medicare
Medicare will cover routine costs related to participation in a covered clinical trial,
"For certain qualifying clinical research studies, Medicare Part A (Hospital Insurance) and/or Medicare Part B (Medical Insurance) cover some costs, like office visits and tests." (source)
Learn more:
https://www.medicare.gov/Pubs/pdf/02226-medicare-and-clinical-research-studies.pdf
https://www.medicare.gov/coverage/clinical-research-studies
Medicaid
As of January 2022, Medicaid will cover routine costs related to participation in a clinical trial, whether the trial is in-state or out-of-state, and in-network and out-of-network. You'll want to refer to your state's Medicaid rules for more information.
Learn more:
https://www.medicaid.gov/state-overviews/state-profiles/index.html
https://www.medicaid.gov/federal-policy-guidance/downloads/smd21005.pdf
Tricare
Tricare will reimburse patients for medical costs related to participation in a cancer clinical trials sponsored by the NCI (National Cancer Institute).
"TRICARE covers the costs for screening tests to determine eligibility for the clinical trial and the costs of participating in the cancer clinical trials.
- If enrolled in a clinical trial taking place at a military hospital or clinic, all outpatient care is provided free of charge.
- If referred to a civilian TRICARE-authorized provider, you are responsible for the same costs as for other TRICARE-covered services.
These costs vary depending on who you are and what plan you are using." (source)
Learn more:
https://www.tricare.mil/Plans/SpecialPrograms/CancerClinicalTrials.aspx
https://www.tricare.mil/CoveredServices/IsItCovered/CancerClinicalTrials
Department of Veterans Affairs
The VA allows participation in clinical trials that are held at VA Medical Centers and sponsored by the NCI (National Cancer Institute).
Learn more:
https://www.research.va.gov/programs/csp/participation.cfm
https://www.research.va.gov/for_veterans/default.cfm
https://www.research.va.gov/for_veterans/volunteering-faq.cfm
Resources on Clinical Trial Costs
Who Pays for Clinical Trials? (National Cancer Institute)
https://www.cancer.gov/research/participate/clinical-trials/paying#
Health Insurance Coverage of Clinical Trials (Cancer.net/ASCO)
Health Insurance and Clinical Trials (Fred Hutch Cancer Center)
https://www.fredhutch.org/en/research/clinical-trials/guide-clinical-trials/health-insurance.html
Non-Medical Costs Associated with Clinical Trials Continue to be Barrier to Diverse Participation (American Cancer Society Cnacer Action Network)
Understanding the financial cost of cancer clinical trial participation (Williams, Courtney P et al. Cancer medicine vol. 13,8 (2024): e7185. doi:10.1002/cam4.7185)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11022148/
How Louisiana cancer patients navigate the ‘hidden’ costs of participating in clinical trials (PBS)
