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How Precision Medicine Will Revolutionize Trial Recruitment


Clinical trials for precision therapies will require a healthy dose of education, collaboration, and data-driven decision-making from everyone involved in the process―not to mention a dedication to digital technology. Justin Grossman reports.

It’s been called the death of the “one size fits many” care model. Indeed, precision medicine―the rapidly developing approach to disease prevention and treatment that leverages individuals’ specific genetic, environmental, and lifestyle parameters―is a meaningful shift for pharma marketers.

Driven by the skyrocketing costs of trial-and-error treatments and powered by vast scientific and technological advances in the fields of genomics and big data, precision healthcare is boosting consumers’ engagement with their medical treatment plans. While physicians are still referring individuals in certain disease states for drug trial participation, patients are beginning to request participation in specific trials; the availability of health monitoring wearables, mass-market genetic screening, and a wealth of digital information give patients a more individualized picture of their health than ever before, enabling them to determine their eligibility for trials and potential treatments.

In order to succeed, clinical trials for precision therapies will require a healthy dose of education, collaboration, and data-driven decision-making from everyone involved in the process―not to mention a dedication to digital technology.

Here’s how those involved in trial recruitment can get ahead of the game now.

The shift: From one-size-fits-all to targeted trial recruitment

“Every day, millions of people are taking medications that will not help them,” writes Nicholas Schork, Ph.D, a professor at the Translational Genomics Research Institute (TGen) in Phoenix. Thanks to recent advances in pharmacogenetics, precision medicine can now pair particular treatments with patients with specific biomarkers. It’s no surprise that this brave new world of pharmaceutical treatment also requires a vast adjustment in the way trial recruitment is approached.

The success of precision medical trials will increasingly depend upon patients self-identifying their fitness for specific treatments.

The challenge: Reaching the right patients

There are a number of roadblocks to finding the right populations for a precision medicine clinical trial. They include:

●      Awareness: Providers and patients may not yet be cognizant of the available trial options, or the specific tests required to uncover biomarker data.

●      Misconceptions: Caregivers and consumers often inaccurately believe that clinical trials are only a treatment of last resort after all other options have been exhausted, instead of a very viable first line of treatment.

●      Outreach: Many trial administrators find it difficult to recruit patients with specific biomarkers via the traditional referral process.

●      Experience: While clinical researchers are often on point to the nuances of precision medicine, physicians may not yet be trained in patient identification, testing, and recommendation.

●      Privacy: The channels by which patients can learn about screening and trial opportunities are often limited due to patient privacy regulations. Even if the patient has genotyping done, the screening service cannot directly suggest the patient seek trial participation. Only the provider can steer patients toward screening by the CRO which can sometimes be a laborious process and is dependant on the fact that the provider is informed of the potential for trial participation.

How marketers can overcome the hurdles of precision medicine trials

While the intricacies of promoting precision medicine trials can undoubtedly seem complex, there are best practices for successfully reaching target populations. It’s crucial for pharma marketers to adjust their strategies in four key areas.

●      Inform providers: HCPs can’t refer patients to a trial if they don’t know it’s happening. Marketers must keep their networks informed of the latest tests available for specific populations in order to gain the right referrals. Unlike with traditional trials, marketers need to educate providers about the unique tests (identifying selective biomarkers, revealing family history and genealogy, etc) needed to determine eligibility for precision trials.

●      Partner for success: Pharma marketers are increasingly finding target trial candidates by getting involved with specialized healthcare advocacy groups such as the Michael J. Fox Foundation. Pairing up with the growing number of organizations dedicated to precision medicine trial recruitment is another resourceful method of outreach, since they target the right population and provide education about eligibility and testing requirements.

●      Develop patient relationships: With an eye toward boosting patient outcomes, pharmaceutical companies are increasingly taking the word to the streets and communicating directly with consumers. In fact, in a recent study 72 percent of Americans agreed that they would choose drugs from a pharma company engaged in their outcome versus one that is not. Directly providing support and educational resources helps build relationships with patients who may qualify for precision treatment trials and may not learn of the opportunities through their provider.

●      Creating patient-facing websites: Sharing information with disease education and awareness sites, and even integrating trial recruitment efforts into paid media, PR, and SEO strategies has helped pharma marketers significantly move the needle for precision medicine outreach. Unlike with traditional trials, this process needs to start much earlier and should focus on education and awareness of patients, not just providers.

The steps: Key considerations for launching a precision medicine trial

The bottom line is this: A revolutionary approach to medicine requires an equally revolutionary approach to trial recruitment.

Unlike traditional drug trials, attracting the target population for precision medicine requires supplementing your outreach plan from the get-go. Awareness and education efforts are crucial to a viable trial. The wrong audience equals the wrong data, which diminishes the chance of drug effectiveness and approval.

Success also depends on mobilizing your entire trial launch team. Marketing investment in patient outreach strategies at an early stage can help you build a pipeline of the right patients, faster. Doing so speeds up the trial process and is more far more cost effective.

There’s no doubt that the time for some out-of-the-box thinking is now. With life-saving treatments at hand and the global precision medicine market set to reach $216.75 billion by 2028, no one wants to get left behind.

Justin Grossman is Managing Partner, meltmedia.

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