“We will not make progress without clinical trials. It’s wrong and unfair to deny patients access to clinical trials.” —Richard Klausner
What Are the Benefits of Clinical Trials?
After researchers have successfully studied a new cancer therapy with the required laboratory and animal studies, investigators develop a clinical trial protocol to begin testing in people, to evaluate the therapy’s safety and efficacy. Such testing is required by the Food and Drug Administration before a cancer drug is approved for use by the public.
The clinical trial process is therefore crucial for advancing cancer science. Understanding the following is necessary to develop novel agents that can lead to enhanced outcomes for patients:
- How the mechanisms regarding how cancer cells develop, proliferate, and spread
- How the environment surrounding the tumor (microenvironment) affects the development and proliferation of cancer cells
- How novel therapies may be used to enhance the body’s immune response to cancer
An increasingly enhanced understanding of tumor biology continues to enable the discovery of novel molecular targets in cancer cells and the development of novel targeted drug therapies.
What Are the Barriers to Clinical Trial Participation?
Only an estimated 3% of adult cancer patients who are eligible for clinical trials actually participate. Multiple studies have identified barriers that may prevent cancer patients from enrolling. All of the following have been found to be barriers, but this list focuses on breast cancer (BC) patients and is by no means all-inclusive.
- BC patients may not realize how necessary obtaining their medical records is for participating in clinical trials. Without them, it isn’t possible to determine whether the patient meets inclusion and exclusion criteria.
- BC is a complex disease that includes multiple molecular tumor subtypes, as well as grades and stages. Not all BC patients are aware of their cancer’s stage, grade, and subtype, yet obtaining such information is crucial in determining appropriate standard treatments and clinical trial eligibility. BC patients need to understand the importance of obtaining pathology reports following a biopsy, breast-conserving surgery, and unilateral or bilateral surgery. Pathology reports provide key information, including estrogen-receptor, progesterone-receptor, and HER2 status, all playing crucial roles in treatment decisions.
- After receiving a cancer diagnosis, patients often don’t know what questions to ask and where to begin to get such information. Some assume that it will be easy to obtain their records and that they’re kept indefinitely, while others become overwhelmed by the very thought of getting all their records. Furthermore, a patient’s physicians may use different electronic health records and not have access to all patient records from other providers.
The result? Cancer patients, most of whom see multiple specialists, may have tremendous difficulty obtaining all their records, potentially causing repeat testing, increased potential harms (e.g., due to repeated imaging), and treatment delays that could impact therapeutic efficacy and increase the risk of cancer recurrence.
Additional frequent barriers to BC trial participation include the following:
- Financial and logistical obstacles of clinical trial participation, such as lost work time, traveling to study visits, and missed time with family
- Lack of information given by oncologists to cancer patients regarding available clinical trials
An ongoing barrier is restrictive eligibility criteria, resulting in the exclusion of specific patient populations, including those with certain comorbidities (e.g., diabetes, cardiovascular disease, etc.) and those with metastatic breast cancer (MBC). The latter are often the most willing to participate due to a lack of effective treatment options. Most MBC patients, particularly those who have initially responded to one treatment, eventually develop resistance to that therapy and are then moved on to the next possible efficacious agent. Most are acutely aware that they have limited treatment options. Thus, patients with MBC should be considered good trial candidates. Unfortunately, restrictive criteria often exclude those who have received extensive “pretreatment” or who have metastasis to the brain.
Breast Cancer Clinical Trials: Breaking Barriers
For patients who would like to be part of breast cancer clinical trials, what steps can they take, and how can they break barriers that frequently prevent their participation?
- It’s crucial to understand the importance of immediately developing an organized approach to obtaining and maintaining all medical records related to your diagnosis and throughout your treatment.
- Ask your oncology nurse or cancer patient navigator how to most easily and efficiently take the necessary steps to achieve medical record management. Also, ask how long your medical records, tumor tissue, and slides will be kept. Note that you’re dedicated to participating in breast cancer clinical trials, breaking barriers that may have prevented BC patients from doing so in the past.
- Ask your oncologist about BC research trials that may be appropriate for you. Unless directly asked, your oncologist may not provide you with such information.
- Use Ciitizen, a free, innovative service that helps cancer patients efficiently organize their health records, find better treatment options, and empower them to obtain the information needed to participate in clinical trials that are optimal for them.
Ciitizen’s CEO, Anil Sethi, built Ciitizen in honor of his younger sister, Tania. During the last months of her life, they crisscrossed the country, visiting countless specialists and institutions where no one had Tania’s full medical records and history. After her death from MBC in 2017, Anila learned that there was much in her medical data that could have extended her life. In the days before her death, Anil promised Tania that he would do everything possible to kill cancer in our lifetime and put control of patients’ health information in their own hands. He left his role as Apple’s director of health records and kept his promise, starting Ciitizen.
Ciitizen provides a free clinical trial matching service for advanced and MBC patients. Ciitizen and its many partners are dedicated to successfully matching this traditionally underserved, much-vested patient population with appropriate clinical trials.
Ciitizen’s blog serves as an ongoing resource for helpful information, interesting topics of relevance to members of the Ciitizen’s community, and moving personal stories that will strongly resonate with anyone affected by BC.
Ciitizen is a free service that helps patients get more out of their health records. Our platform enables patients to find better treatment options and gives them the opportunity to advance the research for cures. Ready to control all of your medical records in one place? Sign up today in less than 5 minutes!