How Precision Medicine is Changing Clinical Trial Recruitment

By Elizabeth Whittington, LunaDNA Contributor

When President Barack Obama introduced “precision medicine” in his 2015 State of the Union, many in the medical field were already familiar with the term. But for the general public, the Precision Medicine Initiative sparked a new way of thinking about disease treatment and prevention; one that takes into account an individual’s genes, environment, and lifestyle. 

In just a few years, precision medicine has changed not only the way we treat and prevent diseases, it has also changed the way research scientists think about drug development and clinical trials. By diving into the causes of certain diseases, scientists have found that many are multifactorial. A one-size-fits-all treatment approach rarely works. The age of blockbuster drugs has been replaced with targeted therapies. And clinical trials that test these new types of treatments are getting an overhaul too. 

The precision problem in clinical trial recruitment

The traditional clinical trial process follows a lengthy and expensive path, from preclinical laboratory work to increasingly larger clinical trial phases that may study treatment safety, dosage, and effectiveness. But as common diseases are stratified into more narrow subpopulations, that model is becoming unrealistic. 

Clinical trial participation in the U.S. has traditionally been very low. Current figures estimate that less than 5 percent of cancer patients enroll in clinical trials. So it’s not surprising that about 40 percent of cancer clinical trials are believed to close before completion merely because researchers cannot accrue enough participants. 

In the age of precision medicine, clinical trial participants must meet a precise list of requirements, such as having a certain subtype of disease or a specific genetic mutation.

To overcome these challenges, the research field is now looking at clinical trial recruitment proactively. Instead of recruiting for patients after a lengthy study design, researchers are directly asking the public to provide their health data as clinical trials roll out. 

Partnering with advocacy groups

It’s a strategy Sharon Terry is already very familiar with. In the 1990s, when her two children were diagnosed with a rare genetic disorder that doctors knew little about, she conducted her own research to discover the genetic cause, and subsequently developed diagnostic testing, clinical trials, and a biorepository to hold biological samples.

Today some organizations, such as the Cystic Fibrosis Foundation, maintain biorepositories, in which scientists can query the data to find new discoveries. These nonprofits may also allow researchers to recruit clinical trial participants from their communities with approval.

“This allows the individuals themselves to raise their hands to be involved in research,” says Terry, who now heads Genetic Alliance, an advocacy organization that hosts patient communities and a biobank to aid in medical research.

Clinical trial recruitment creativity

Pharmaceutical companies, study investigators, and medical research institutions are now reaching out to nonprofit and advocacy organizations in unique ways to recruit for highly specialized clinical trials. 

“I think the common conditions have the opportunity to learn a lot from us rare diseases because we’ve always dealt with small populations,” Terry says, especially when a non-profit group is filled with empowered patients who want to advance medical research.   

Nonprofit organizations were founded on the goals of providing resources and emotional support, and raising awareness of a particular disease to the general public, especially rare diseases. Many quickly evolved into activism, lobbying, and research funding. The next evolution is having a direct impact in medical research through education on precision medicine, research funding, and recruiting for clinical trials.

Earlier this year, LunaDNA announced a partnership with the Genetic Alliance. By linking the participant and patient communities of the Genetic Alliance to LunaDNA’s research platform, individuals will have more resources to share their health data for medical research and to understand their options for clinical trials.

Industry-advocacy partnerships will continue to evolve, but it may not be from necessity, but from a shared mission.

“[They] say that finding people for clinical trials is like looking for a needle in the haystack,” Terry describes. “But basically, no, it’s not. The haystack is made out of needles.

“In this case, every single one of us is useful to a clinical trial somewhere. My goal and the goal of LunaDNA is to bring as many people as possible into the system, and then they’re ready for a clinical trial.” 

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