April 25th, 2018 Why Are We Leaving Older Adults Out of Clinical Trials? Clinical trials often exclude patients over 70 years old from participating. Why has this become a trend, and what does it mean for the efficacy of clinical research? Patient recruitment is often an obstacle to achieving the right demographic breakdown in clinical trials. Unfortunately, issues with recruitment and other obstacles have led to certain populations being excluded from clinical trials altogether. The New York Times recently published a piece titled “The Clinical Trial Is Open. The Elderly Need Not Apply.” According to the article, a prominent CDC study that sought to understand Americans’ salt intake – an issue with particular relevance to older patients who may suffer from high blood pressure, swelling, and heart disease – purposefully excluded those who were 70 years and older. In its defense, the CDC explained that older patients were less likely to participate in the study as it was designed – it required 24-hour urine collection – which would have risked creating a skewed sample. However, the idea that older patients are either unfit to participate in clinical trials or unaware of what they involve, or even how to enroll, reflects wider misunderstandings on the part of sponsors and CROs – misunderstandings that need to be corrected. Age Discrimination in Clinical Trials The recruitment limitations exhibited in the CDC study are not uncommon in the clinical trial industry. In 2011, experts from the University of Michigan reviewed over 100 clinical trials published in respected journals and found that 20 percent set an upper age limit for participation. While this is an improvement over an earlier review of trials published between 1994 and 2006 that found that nearly 40 percent prevented people 65 years and older from enrolling, it still shows that 1 in 5 studies discriminate based on age. Unfortunately, many of these trials are researching diseases that have specific relevance for elderly patients. Dr. Florence Bourgeois of Harvard Medical School conducted a study of clinical trials for heart disease medication, a study that ultimately found that 53% of such trials actively excluded participants based on age. Further, Dr. Bourgeois and her team noted that little over 10 percent of patients were 75 and older. For an area of medicine that affects elderly patients so consistently – the CDC reports that heart disease is the leading cause of death among Americans 65 years and older – exclusion based on age has negative ramifications for people in need of cutting-edge care and clinical trials alike. Without studies on how medications and novel treatments affect the elderly, we’re missing out on important medical information that could prolong or even save lives. How Sponsors and CROs Can Enroll Older Patients While age caps in clinical trials may be less frequent than they were two decades ago, sponsors and CROs still need to develop effective strategies to enroll older participants if they want to produce research that’s widely applicable to patients in need. To do so, trials can leverage digital marketing to reach out to potential patients in their 60s, 70s, and beyond. In fact, 66 percent of adults over the age of 65 use the internet regularly, meaning that investigator sites have every tool at their disposal to recruit the right patients. For example, Facebook offers trials the option of serving content to users who fit their ideal demographic. By prioritizing users who are 70 years and older, and who have liked pages related to treatment of specific chronic conditions, trials can appeal directly to those who might be able to gain the most from participating. However sponsors and CROs choose to reach out to potential patients, it’s vital that age discrimination isn’t a factor. By conducting research with participants from across the demographic spectrum, clinical trials can produce results that stand to benefit everyone – not just a select few.
Clinical trials often exclude patients over 70 years old from participating. Why has this become a trend, and what does it mean for the efficacy of clinical research? Patient recruitment is often an obstacle to achieving the right demographic breakdown in clinical trials. Unfortunately, issues with recruitment and other obstacles have led to certain populations being excluded from clinical trials altogether. The New York Times recently published a piece titled “The Clinical Trial Is Open. The Elderly Need Not Apply.” According to the article, a prominent CDC study that sought to understand Americans’ salt intake – an issue with particular relevance to older patients who may suffer from high blood pressure, swelling, and heart disease – purposefully excluded those who were 70 years and older. In its defense, the CDC explained that older patients were less likely to participate in the study as it was designed – it required 24-hour urine collection – which would have risked creating a skewed sample. However, the idea that older patients are either unfit to participate in clinical trials or unaware of what they involve, or even how to enroll, reflects wider misunderstandings on the part of sponsors and CROs – misunderstandings that need to be corrected. Age Discrimination in Clinical Trials The recruitment limitations exhibited in the CDC study are not uncommon in the clinical trial industry. In 2011, experts from the University of Michigan reviewed over 100 clinical trials published in respected journals and found that 20 percent set an upper age limit for participation. While this is an improvement over an earlier review of trials published between 1994 and 2006 that found that nearly 40 percent prevented people 65 years and older from enrolling, it still shows that 1 in 5 studies discriminate based on age. Unfortunately, many of these trials are researching diseases that have specific relevance for elderly patients. Dr. Florence Bourgeois of Harvard Medical School conducted a study of clinical trials for heart disease medication, a study that ultimately found that 53% of such trials actively excluded participants based on age. Further, Dr. Bourgeois and her team noted that little over 10 percent of patients were 75 and older. For an area of medicine that affects elderly patients so consistently – the CDC reports that heart disease is the leading cause of death among Americans 65 years and older – exclusion based on age has negative ramifications for people in need of cutting-edge care and clinical trials alike. Without studies on how medications and novel treatments affect the elderly, we’re missing out on important medical information that could prolong or even save lives. How Sponsors and CROs Can Enroll Older Patients While age caps in clinical trials may be less frequent than they were two decades ago, sponsors and CROs still need to develop effective strategies to enroll older participants if they want to produce research that’s widely applicable to patients in need. To do so, trials can leverage digital marketing to reach out to potential patients in their 60s, 70s, and beyond. In fact, 66 percent of adults over the age of 65 use the internet regularly, meaning that investigator sites have every tool at their disposal to recruit the right patients. For example, Facebook offers trials the option of serving content to users who fit their ideal demographic. By prioritizing users who are 70 years and older, and who have liked pages related to treatment of specific chronic conditions, trials can appeal directly to those who might be able to gain the most from participating. However sponsors and CROs choose to reach out to potential patients, it’s vital that age discrimination isn’t a factor. By conducting research with participants from across the demographic spectrum, clinical trials can produce results that stand to benefit everyone – not just a select few.
