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August 29th, 2018

Why Age Diversity Matters in Clinical Trials

Age diversity

Too many clinical trials exclude older patients because of difficult recruitment processes or comorbid conditions. But digital marketing can help round out this critical patient segment.

The fundamental assumption behind clinical trials is that a relatively small sample of patients can accurately represent the larger patient population. A well-managed trial allows sponsors and CROs to project the effects of a given treatment onto the public. However, if the demographics aren’t representative of the patient population, the assumption of parity becomes extremely flawed.

Unfortunately, that’s exactly what’s happening with older portions of the population. According to a 2011 study, 20% of trials prevent patients over a certain age from enrolling. Another study from last year found that over half of drug trials for heart disease, a problem that largely affects older people, exclude elderly patients.

The Catch-22 of Patient Exclusion

Clinical trials aren’t shutting out older patients for no good reason. Often, sponsors and CROs have good intentions when setting upper age limits. For one, clinical trials never want to place at-risk populations in harm’s way by administering them an untested drug. These sensitive populations include pregnant women, children, patients who have comorbid diseases, and the elderly.

As a result, these populations are frequently left out of studies. The reasoning for these omissions seems sound, but they can sometimes create major blind spots and ultimately result in tragedy. In the 1950s and 60s, for example, the drug thalidomide was frequently prescribed to pregnant women to treat morning sickness. Sadly, the drug was later linked to severe birth defects, a finding not observed in the original study because it excluded pregnant women.

On the other hand, this tragic scenario also demonstrates the risks of including sensitive populations in trials. Had pregnant women been included in the original trial, that smaller number of women would still have had to face the same terrible consequences. It’s easy to imagine how something similar could occur among older patients, too, creating a difficult catch-22 for clinical trials.

Similarly, trials wish to avoid confounding variables when testing new drugs, so they usually don’t include patients who are taking other medications. Because many older people take daily medications, this rule acts as another barrier between clinical trials and the elderly population. It’s understandable that trials would want to eliminate added variables, but these trials frequently fail to collect data on how different medications react with the treatment they’re testing. This make physicians hesitant to prescribe the new treatment to patients who are already taking other medications.

How to Include Older Patients with Minimal Risk

While it can certainly be tricky to include older patients in clinical trials, there are ways to do so without presenting great risks to their wellbeing or the integrity of data collection. CROs and sponsors should make every possible effort to do so in order to understand their treatments’ effects on every segment of the population.

The best way to safely include elderly patients is to accept them into the trial on a case-by-case basis. This allows investigator sites to determine which older patients are healthy enough to participate, minimizing risk without setting an upper age limit.

A case-by-case approach to senior patient recruitment requires active enrollment efforts, which many trials fear will be a huge investment of time and money. However, digital marketing strategies can make it very affordable to quickly reach a large number of older patients. 63.7% of Baby Boomers over the age of 66 are active internet users, according to eMarketer. Additionally, Pew reports that more than 50% of those over the age of 50 use social media on a regular basis, representing a 57% increase since 2009.

According to AdWeek, older generations are just as likely as their younger counterparts to share content on Facebook, and they actually consume more digital content than younger generations. A large portion of this content is health-related; 58% of those 65 and older currently use the internet for exactly this purpose, making health searches the number-one reason that they go online.

Thanks to older patients’ strong internet usage, search and social media ads are a cost-effective way to reach new patient populations. Facebook boasts an audience of 21.1 million users over 65, and often contains 100% representation of a given condition. Trials can use precise demographic targeting tools to reach older people who might be interested in clinical trials, as well as their caregivers. Meanwhile, search ads offer an opportunity to reach patients who are actively looking for treatment options.

With the technology available for patient recruitment, there’s no reason to neglect older patients as part of a clinical trial. With the right digital marketing strategy, sponsors and CROs can ensure that their study is more representative of a larger patient population.