Patient adherence critical to accuracy, FDA approval of clinical trials

Marketing in clinical trials is often relegated to the last moments before a product hits market release. After all, researchers are only focused on test results or the diagnostic performance of medical devices. To a general observer, it would seem that marketing - a business-driven concept - has no place in clinical trials until the very last phases.

However, the alarming rate of failed drugs and ever-present regulations from the U.S. Food and Drug Administration have changed how marketing is being used by clinicians across the country. As more trials struggle with low patient adherence rates, everything from the validity of tests to enrollment numbers may be in jeopardy, but multi-channel marketing strategies that communicate with patients in a familiar and accessible register may be an incredibly beneficial tool as trials approach FDA approval.

Patient adherence rates lag
A recent study conducted by the National Community Pharmacists Association looked at 1,020 adults over the age of 40 who had been prescribed medication for a chronic condition - ideal candidates for many clinical trials. Representing 30 percent of the overall adult population, this group received a "C+" grade average from the NCPA for its patient adherence competency. 

More concerning for clinical researchers is the fact that 15 percent of participants - roughly 10 million potential trial participants - received an "F" rating.

Patients who cannot regularly adhere to a medication regimen threaten clinical trials in multiple ways. Researchers are likely on the lookout for poor adherence rates, and patients who continually refuse to stay faithful to their prescriptions cannot be trusted to deliver accurate results in tests. This threatens the validity of the entire trial and the FDA will almost certainly notice inaccurate results during the approval process. Alternatively, removing these patients from the trial lowers enrollment, and too few patients could be similarly damaging.

Multi-channel marketing makes waves
A 2004 study by researchers at the University of California, Riverside found that self-reporting in clinical trials actually had a negative effect on patient adherence rates. Instead of trusting study participants to follow instructions on their own, multi-channel marketing that creates a meaningful link with subjects can help researchers avoid the pitfalls of patient adherence. 

To combat patients' apathy or indifference to their own conditions, it is vitally important to frame educational materials in language and media that they are familiar with. This includes accessible writing and distilled medical information, as well as a campaign that leverages both physical and digital advertising to create a personalized context for each individual's unique situation.

There are so many ways that clinical trials can go wrong. Reach out to a marketing agency to make sure patient adherence is not one of them.