Age discrimination must end in cancer clinical trials

Cancer pain More elderly More than any other age group. In fact, more than half of the cancers diagnosed in the United States occur in cancers over the age of 65.That number is expected to reach 70 percent by 2030As the population experiences an unprecedented boom in the elderly. More and more targeted cancer treatments and immunotherapies are available today, but older people often do not have access to these options. High risk of dying From their illness. Also, even with the latest medications available, these treatments, such as multiple myeloma, may not work well in ethnic minority groups, especially older patients. This gap in the care of some older people is even greater due to racial, economic and geographical barriers.

Age is “Just a number, “What is preventing older people from receiving quality cancer treatment? One factor is the lack of evidence of clinical trials to help oncologists make informed decisions about the best possible treatment options. Historically, clinical trials haven’t taught us much about how cancer treatments in the elderly work. This problem primarily results from the continued underestimation of the elderly in clinical trials.Studies show Cancer patients over 65 years old Only about 40 percent of new cancer treatment enrollment trial enrollees. Such trials are used to determine the benefits and safety of potential new therapies and are an important step towards obtaining approval from the US Food and Drug Administration. This imbalance is even more serious for people over the age of 80, who make up only 4 percent of what is included in the registration exam. As a result, treatment strategies are often based on data from young people.

Cancer associations, advocacy groups, and regulatory agencies have made some recommendations to address this growing problem. These include various recommendations from regulatory bodies and industry organizations, including: FDA And that American Society of Clinical Oncology (ASCO) For leveraging research design to generate evidence from older people with cancer and empowering the FDA to request studies involving older people. Despite these steps, older people are still underestimated. A Recent analysis Of the 302 industry- and non-industry-sponsored clinical trials, overall, the median age of participants was shown to be approximately 6.5 years. Years younger than the median age of sick people To the general public. Median age is even lower in industry-sponsored trials, further demonstrating the important role the pharmaceutical industry plays in accurately representing older people in future clinical trials.

Co-authored three papers focused on improving the diversity of clinical trials published in. cancer, National Cancer Center JournalWhen Hematology oncology.. They propose a set of recommendations to ensure that the age and ethnicity of patients in clinical trials reflects the age and ethnicity of people suffering from this disease in the real world. Here are some recommendations:

• Reassess Criteria for Clinical Trial Registration-Criteria for excluding people, especially based on age. This could be one of the main reasons for the lack of expression we see today. Alternative eligibility criteria In particular, excluding patients based on factors such as functional status, organ function, and comorbidity contributes to underestimation. In the healthcare industry, we need to consider establishing an internal task force to support clinical trial teams and promote age diversity. For example, we established Pfizer’s Diversity Inclinical Trial Center of Excellence. It facilitates enrollment that reflects the actual population and provides demographic data to help you choose the right trial location early in the research design process. Sponsors need to rely on early-stage data, real-world evidence, and translational research to ensure that clinical trials are designed for ethnic minority groups and older patients. We also work with geriatric oncology experts, community-based physicians, patient representatives, and caregivers at various stages of study design to ensure that appropriate study eligibility and criteria are used. Must be.
• Includes research endpoints suitable for the elderly Then use the geriatric evaluation tool in the exam to enroll people in this age group. Most cancer trial goals focus on survival, but by adding specific endpoints and patient-reported elderly outcomes, we can better understand how treatment affects this group. You can draw accurately. Geriatric assessment data such as exercise, brain function, weakness measurements, nutritional status, and comorbidities collected during the study measure the benefits and risks of treatment in the elderly and may lead to worsening illness and death. It also helps to identify certain predictors more accurately.
• Raise awareness and access to clinical trials Among the elderly living with cancer.Beyond strict eligibility criteria, studies analyzing perceptions among academic and regional oncologists have shown that older people are usually not considered to participate in clinical trials as a result. Prejudice or unfounded health concerns..Elderly patients Lack of information About the exams they have available. This is a problem. The adoption of digital and virtual tools brought about by the COVID-19 pandemic has been used to improve the diversity of clinical trial participants, including in rural areas and areas with restricted access to research institutes. Should be. In areas where physicians, researchers and patients face communication barriers, sponsors need to provide soft skill training programs and communication tools with appropriate messages for age and ethnic minority groups.
• Build trust through customized education. Maximizing trial participation among older and ethnic minority people requires broader patient involvement. Sponsors should be led by community health educators and use appropriate tools to design and implement community-led programs. These programs can reach the elderly through channels they already trust. Communication needs to address issues such as the fear of experimentation resulting from historical exploitation in medical research.
• Report data specific to the elderly and ethnic groups It can be used to help oncologists make more appropriate treatment decisions. One of the approaches my colleagues and I have taken in breast cancer research is to use pooled analysis from several trials to generate and report efficacy and safety results in a larger group of older people. is.

My hope is that behavior in these key areas will improve the inclusion of older people, including those with ethnic minority backgrounds, in future clinical oncology studies. Pfizer further supports efforts to address health care, policy and social barriers that impede the best care of the elderly. This lives with cancer Called an “online community”As we get older“Especially for sharing resources and tools with people over the age of 65 who have cancer.

Throughout the healthcare community, we are responsible for improving the quality of care all Patience. Changing the way older people express themselves in cancer research is the first step in the right direction.

This is an opinion and analysis article, not necessarily the views expressed by the author or multiple authors. Scientific American.