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Millennials accelerate seismic shift in clinical operations

Saturday, April 1, 2017

As the largest age demographic in the U.S., Millennials are dramatically reshaping the clinical research industry. Millennials have high expectations about technology, convenience and data transparency—traits that are catalyzing a trend toward decentralization and prompting industry leaders to carve out new roles in clinical trial management.

“I think the most dramatic characteristic of the Millennial demographic is their willingness to embrace tech,” said David Blume, managing director, Edgemont Capital. Wearable technology, remote patient engagement tools and mobile apps are already emerging as major themes in clinical research, and shifting demographics will dramatically accelerate adoption, he added.

“There is a drive by the pharmaceutical industry as a whole toward patient centricity, and for millennials, technology will be the cornerstone of achieving this,” said Tim Davis, VP, Digital Patient Solutions, ERT. “The challenge for industry will not be the introduction of technology itself, but the ability to continually integrate new technologies as they become adopted in the real world,” Davis said.

There are more than 75 million Millennials in the U.S., surpassing even the Baby Boomer population. Although there is no universal definition, Millennials are typically described as people ages 20 to 36 in 2017. As they age, this group is increasingly entering the research industry—both as patients and as part of the workforce.

As patients, Millennials are more likely to expect their participation in clinical research to be convenient and meaningful. They also expect technology to be intuitive, and that any data gleaned from a trial will be shared at its conclusion. If a trial does not meet those criteria, they are likely to “shop around” for other options, unlike older generations who are more likely to accept trial criteria at face value, said Jane Shen, Pharm.D, senior director of Innovation, PMG Research.

Because Millennials grew up with the internet, they have a “culture of triangulating the truth,” meaning they consult multiple online sources before making an important decision, explained Tushar Jain, chief operating officer, ePatientFinder.

Millennials are not only changing the industry as patients—they are also increasingly entering the workforce as researchers, site coordinators and clinicians. In these roles, Millennials will accelerate the changes already taking place within the industry. They are less likely to accept inefficiencies around data collection and management, and are more likely to advocate for decentralized clinical trials. They may even re-shape traditional management roles, carving out new job descriptions for specific data management and technology needs.

Great expectations

All Millennials—from patients entering a trial to employees entering the workforce—have high technology expectations. The industry is facing massive pressure to not only develop apps and other mobile technologies, but to fundamentally re-think trial design around a “decentralized” or “networked” model.

Traditionally, the organizational structure of clinical trials has been based at large academic centers, but Millennials might turn that tradition on its head. Compared to Baby Boomers, “Millennials will be less tolerant of old school workflows,” said Jain, adding that for Millennials, having the latest technology “is almost linked to the credibility of the institution.”

“The growth of Millennials in key clinical research roles will have a huge impact on the way trials are delivered and managed,” said Davis. “It will no longer be acceptable for clinical systems to stand alone, with outdated user interface/user experience. Ideally, site visits will become a thing of the past or at least significantly reduced, and the Internet of Medical Things will enable all kinds of data to be collected by apps, wearables and sensors to provide proactive feedback to all parties involved in the clinical process.”

Millennials will be “champions to getting more digital and remote,” agreed Shen. “You will probably see more decentralized and remote trials, which will dramatically impact how the research is being conducted.”

The new model will look more like a “networked organization” in which patients will answer survey questions remotely, communicate with coordinators via email or Skype and perhaps even make use of Amazon Prime Air, a drone delivery service, to send and receive tangible items such as wearable devices, said Matthew Howes, executive vice president, Strategy & Growth, PALIO, an inVentiv Health company.

Another trend Millennials are likely to embrace is crowdsourcing clinical trial protocols, said Howes. Crowdsourcing in other industries has proven itself to be “a quick way to get smart ideas,” and crowdsourcing a protocol would “change the culture of how people think about collaborating” on protocol design.

Sharing and altruism

Millennials are altruistic, according to multiple surveys demonstrating that their top career priorities are a sense of purpose or meaning rather than income or status. When it comes to their participation in clinical research, Millennials want to know that their contribution is really making a difference, and they want to be able to share that information with their peers.

Millennials want to “make sure they’re having an impact, and that they are not just a guinea pig,” said Howes. Millennials may have a more negative impression of clinical research, with 42% reporting that participation amounts to “gambling with their health,” compared to only 33% of people ages 55 to 64 who feel that way, according a 2015 survey by the Center for Information and Study on Clinical Research Participation (CISCRP).

To better engage Millennials, PMG  Research’s Shen said sponsors should “provide real-time data that matters to patients, and foster the connection within their care community, such as their providers, family and caregivers.”

During a trial, “technology will be used for so much more than data capture or medication reminders,” said ERT’s Davis. It will also “allow patients to access information on the trial, their progress and their condition,” he said.

Over the last several years, there also has been a “big push for study results to be shared with patients,” said Tony Taricco, president, COO, PRC Clinical. “Millennials are inherently collaborative, they are used to sharing information and they want feedback.”

Not only do Millennials want more data transparency, but they also want to be able to easily share results with their peers and social communities, said Shen. They also want to be able to rate their experience with a clinical trial—along the lines of Yelp for clinical research.

Recruitment challenges

Only 24% of young people ages 18 to 34 reported feeling “very willing” to participate in clinical research, compared to 47% of people ages 55 to 64, according to CISCRP.

Now that society has “turned a corner technologically, everyone is wondering how to improve recruitment and retention” in clinical trials, said Taricco.

A traditional bus stop advertisement is going to strike Millennials as “wrong place, wrong time,” said Howes. Instead, sponsors should try to recruit Millennials in the same place they are searching for information—Google or social media.

Recruitment will need to take place almost exclusively on social media, agreed Paula Brown Stafford, adjunct professor, University of North Carolina at Chapel Hill and former president of clinical development for Quintiles. Because Millennials are relatively young, they are less likely to suffer from common chronic conditions. Instead, they are more likely to belong to a tight-knit online social network of peers who might share their specific diagnosis.

Millennials are also accustomed to cross referencing information shared by sponsors with online resources, physicians and peers. “Trust is a key component of recruitment because patients really want to know that they’re going to be taken care of,” said ePatientFinder’s Jain.

Another trust issue: Young people are less confident that clinical research is safe compared to older people, according to CISCRP. In addition, once enrolled, young people were more likely to drop out of studies, and 53% reported their trial experience to be “somewhat stressful” compared to only 13% of people older than 55 who felt that way.

To overcome these challenges, sponsors should look to build trusted patient networking communities, and also improve data transparency during and after a clinical trial so that patients understand exactly how their participation contributed to a greater good.

Carving out new roles

Over the next several years, the research industry will need to create new roles to address the increasing technological sophistication of clinical trials.

A totally decentralized trial—in which patients never visit a central site—is hard to imagine, but the industry is moving in that direction. The trend will change the current roles and culture of clinical trials, said PALIO’s Howes. To adapt, the industry needs to carve out new roles to manage the digital infrastructure needed for remote operations, Howes added.

According to PMG Research’s Shen, one of these new roles will be a “research technologist,” which she describes as a navigator who understands clinical research as well as the technology that will connect patients to a site. It’s almost a hybrid position between a research coordinator and an IT person, Shen said.

Luckily, more and more universities are offering specific training in the regulatory sciences, so Millennials are graduating with the training they will need to hit the ground running, said University of North Carolina’s Brown Stafford.

“Millennials today have an opportunity for a more direct educational experience to prepare them for these roles,” said Brown Stafford. “I think the quality of clinical trials will improve because people are going to be trained more specifically toward regulatory sciences.”

Questioning the status quo

As Millennials enter the research industry as patients and workers, they challenge current processes they consider outdated or inefficient.

When it comes to recruitment, industry sponsors need to shift their efforts to include a combination of social media and online advertisement. Researchers should try to build trusted online communities that facilitate peer-to-peer sharing. To build trust, sponsors need to be more transparent with results both during and after a trial’s completion.

Sponsors need to consider providing remote patient monitoring options to improve trial convenience. Shifting demographics will inevitably accelerate the existing movement toward trial decentralization, and sponsors who embrace this trend are more likely to see buy-in from younger demographics.

As doctors, nurses and site coordinators, Millennials are more likely to enter the industry with advanced training, freeing up time to think creatively about how to streamline trial operations. They may carve out new roles, recognizing that technology and data management requires a unique set of skills.

Overall, current trends of decentralization, technological sophistication and increased transparency will accelerate as more Millennials enter the clinical research industry. “I think, ultimately, it will be millennials who push through change in the way the industry addresses clinical trials,” ERT’s Davis said. 

 

Sony Salzman is a freelance journalist reporting on healthcare and medicine. She earned her Master’s degree from Boston University’s Science Journalism program, and has won multiple awards for narrative writing and radio journalism. Email  sonysalz@gmail.com or tweet @sonysalz.

This article was reprinted from Volume 24, Issue 04, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>

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