The beginning of the year is a perfect time to reflect on your accomplishments and challenges during the previous 12 months.

Looking back on patient recruitment successes and failures reveals some of the most challenging patient recruitment scenarios. Recruitment for special categories such as pediatric rare diseases and elderly populations likely will top the list of challenges for many.

When referring to elderly populations, many different terms are used. A “geriatric patient” is an older person with impaired overall function. There is no set age, but he or she is usually older than 75, with chronic illness(es), physical impairment and/or cognitive impairment. An “elderly patient” is defined by most developed nations as someone 65 years or older who may or may not need specific medical treatment (geriatrics). The term “older patient” or  “older population” refers to both groups.

The volume of older populations is increasing rapidly; as a result, they will need to play a more significant role in clinical research. According to the U.S. Census Bureau’s “middle series” projections, those populations will more than double to 80 million between now and 2050. By that year, as many as one in five Americans could fall into the “elderly or over 65 years old” category. Most of that growth should occur between 2010 and 2030, when the “baby boom” generation enters their elderly years. During that period, the number of elderly will grow by an average of 2.8% annually. By comparison, annual growth will average 1.3% during the preceding 20 years and 0.7% during the following 20 years (see graph).

Many of us assume that participation in clinical research simply will mirror the current population, but there is a gap of underrepresentation. According to a 2015 inVentiv Health global survey, elderly patients top the list of those most under-represented in clinical research. This trend is alarming because older populations use medicine most frequently yet are the most underrepresented group. An evaluation published by the British Medical Journal revealed that elderly patients were part of the exclusion criteria for nearly a third of trial protocols. The most widely used age range for protocols is 18 to 65 years. Elderly patients make up more than a third of the population that ultimately would benefit from the use of those drugs in practice but are excluded most frequently.

It is important to widen the age criteria and understand how medicines work in older populations, but doing so poses other problems. Older patients often have multiple chronic diseases. Between 15% and 20% of people over the age of 65 are “polypharmacy patients” (taking more than 10 different drugs at the same time). That scenario puts the elderly patient at an increased risk of treatment mistakes and side effects, but is also one of the most important reasons to have older populations included in clinical trials in the first place.

The FDA has recognized that lower participation by patients older than 75 is thought to reflect protocol exclusions and has created an “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” The goal is to identify barriers to subgroup enrollment in clinical trials and to employ strategies to encourage greater participation. As more people recognize the disparity in the older patient population and widen the age range, we must adapt patient recruitment strategies to include the elderly.

Recruiting older patient populations may require a different approach. What works well to recruit 30-year-olds does not always transfer to the 70-and-older crowd. For example, digital media campaigns may or may not work; traditional media may have a higher return on investment; call centers become more important and community outreach may work well to recruit older patient populations.

Recruitment should reach the influencers, too. Caregiver influence is a major consideration in recruitment; as patients age, the chances assistance will be needed increase.

Other considerations include adapting the informed consent process to include tools such as flip charts and video primers—videos can provide high-level information that can aid understanding and facilitate discussion. Transportation is another factor and may be a barrier to many older people who would volunteer; simply providing a ride can remove that hurdle. Materials for patient education may be more important for the older population and should be designed for educational purposes and to enhance the study experience for patients and caregivers—the goal of the materials is to provide the fundamentals about the disease state and teach about clinical trial participation.

As more protocols widen the age range, patient recruitment strategies and tactics provided for the trials should be designed to ease communication and complement the physician/patient relationship for success. Different approaches may be required in order to meet recruitment goals in older populations. 

Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently, she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to tointon@icloud.com.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »