Written by: Beth Dougherty
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Clinical trials assess new medicines to ensure they are safe and effective and to find out which patients they are most likely to benefit.
However, clinical trials often enroll few people of color for a constellation of reasons related to historical marginalization of certain groups. Systemic marginalization can result in lower levels of income, fewer resources for support, less access to medical care, and higher rates of chronic disease, all of which can affect access to clinical trials.
As a result, the findings from clinical trials may only reflect the experiences of a limited portion of the population. What works in one part of the population might not work the same or as well in another.
As a result, it’s important to increase the diversity of patients who participate in clinical trials. At Dana-Farber, many efforts are underway to improve access to clinical trials. Those efforts are being led by Erica Mayer, MD, MPH, director of clinical research in the Breast Oncology Program, and breast oncologist Rachel Freedman, MD, MPH, who is co-chair of Dana-Farber’s Clinical Trial Access Committee.
“We really need to work as hard as we can to create clinical trials that include a diverse population of patients and that are accessible and available to anyone who wants to participate, so that the results of trials apply to the entire population and not a limited group,” says Mayer.
Their efforts can be grouped into three categories:
Attention to details
Clinical trials can be extremely involved. The details of the trial’s design, communication materials, and operations matter to the participants and to the science. With careful attention to details, investigators can reduce barriers to entry into a clinical for many patients.
Dana-Farber breast cancer investigators are paying close attention to the details of clinical trials to make sure that all trials are as open and inclusive as possible while still being safe and scientifically sound.
For example, in many cases, to be eligible for a trial, the health metrics a patient needs to enroll are very stringent. In these cases, the required health metrics may unintentionally exclude people with certain conditions, such as kidney or heart disease.
Now, at Dana-Farber and elsewhere, new policies aim to expand eligibility criteria as much as possible, so that metrics are in place to assure safety but also to broaden the reach of clinical trial access. “At Dana-Farber, an investigator should think about and justify every single lab value specified for eligibility,” says Freedman. “If you’re going to exclude people with a chronic kidney condition, for example, you should have a strong rationale for why it is important.”
Other details that affect inclusion include:
- Language considerations: Many patients in the U.S. predominantly speak languages other than English. They need native-language materials to understand and consent to participate in a clinical trial. Dana-Farber’s Clinical Trial Access Committee is finding ways to support translation of materials for patients, such as informed consent and surveys, into more languages so that more patients can participate.
- Support for visits: Patients who enroll in clinical trials typically will have more frequent clinic visits that can be time consuming. These requirements can exclude people who do not have flexible employment hours, have families that need their attention, or who might struggle to afford transportation, parking, or meals out. The Clinical Trials Access Committee is also finding ways to provide financial assistance for patients in need who enroll in clinical trials to cover transportation, meals during long appointments, and other assistance that could make participation easier to manage.
- Patient navigation: The breast oncology team at Dana-Farber will be initiating a pilot study where a breast cancer research navigator will be hired to help patients navigate resources and services during their time participating in a clinical trial.
Reaching patients locally
It is impossible for a patient to enroll in a clinical trial if they don’t know what one is and if they don’t know one might be available to them. Dana-Farber’s breast oncologists are working with patient advocates and with colleagues to help bridge this gap.
- Information and patient testimonials about clinical trials will be shared in Dana-Farber waiting rooms and on Dana-Farber social media channels to help more patients learn from the experiences of others. Much of this work is led by the Dana-Farber Breast Cancer Patient Advocate team.
- Dana-Farber is increasing the number of clinical trials available at its community-based locations, so that more people in the region can participate without a trip to the main locations in Boston and Chestnut Hill.
Reaching patients broadly
Dana-Farber is known for excellence in the design and execution of clinical trials. Outreach beyond the local area will help more patients participate.
- Dana-Farber’s breast oncology clinical investigators partner with major cancer centers to run multi-center clinical trials in places with diverse populations to reach more people of color and of diverse backgrounds.
- Dana-Farber’s Cancer Care Collaborative, which is a consortium of institutions around New England and beyond, is partnering to open Dana-Farber clinical trials at their sites, expanding access to trials into a wider set of communities.
“Increasing diversity in clinical trials is a nationwide problem,” says Freedman. “But groups that run trials all over the US are improving their community engagement and opening clinical trials in community and rural settings on a much grander scale. There’s momentum both here and across the U.S. to make this better.”
Learn more about Dana-Farber clinical trials.
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- Source: https://blog.dana-farber.org/insight/2024/05/dana-farbers-focus-on-equity-in-breast-cancer-clinical-research/