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Subject Matter Experts: Why you want one on your CRO team

August 4, 2016

It’s not hard to see that the relationship between sponsors and contract research organizations has evolved. Less obvious is the unexpected impact the changes have had on the way clinical trials are being run and the people running them.

Take subject matter experts. They used to be the ones working behind the scenes of a clinical trial, usually hired directly by the sponsor, who normally had no more than a few drugs in development.

Now that sponsors are outsourcing trials, subject matter experts are more likely to be found on the team of a CRO, pooling their expertise with that of others. PRC Clinical CRO

The transition is important because, as part of a CRO, they are exposed to dozens if not hundreds of different trials, approaches, drugs, geographic perspectives and sponsors, according to John Lewis, senior vice president of policy and public affairs at the Association of Clinical Research Organizations.

“There’s been a big shift,” Lewis said.

That can pay off in smarter trial design and knowing where to look for participants, he said. “It’s a higher level of service.”

What’s in a name?

That’s why Lewis calls them “the talent.”

And yet sometimes it’s hard to know just what a subject matter expert is — or isn’t.

As the title would imply, they have a specific expertise in a subject. After that, the distinctions get messier.

There’s a generic use for SMEs who speak on panels or consult on studies. A search of the phrase “subject matter expert” on the PubMed database returned 427 results, most if not all fitting into this broad definition. This version helped improve post-surgery care and the understanding of addiction among long-term opioid users. They suggested the U.S. military issue stylish protective eyewear to soldiers in Iraq and the rate of eye injuries dropped.

Just to make things more confusing, sometimes a key opinion leader (KOL) is called a subject matter expert. The crossover is easy to understand. After all, KOLs do have specialized expertise in a particular field, such as oncology. But there is a distinction, the main one being that key opinion leaders are there for their ability to sway the industry.

They are prominent figures in their field, like doctors or academics who have published widely. So when a KOL accepts, or rejects, a new treatment, others are apt to follow their lead, said Terri Hinkley, deputy executive director of the Association of Clinical Research Professionals. They bring legitimacy to the endeavor, she said. “By gaining their buy-in, companies hope to be able to influence practice.”

SMEs also bring a combination of education and experience to the table. They too might have been an academic or had a private medical practice and are now on the research side. But, unlike KOLs, subject matter experts are on board to run a trial, look at results and move the trial forward, Lewis said. They’re job is not to influence a trial, he said. “That’s not their role or their interest.”

The nuance is captured in this description about their role vetting protocols.

“Reviews by subject matter experts should be conducted to reduce the potential risk in the initial development of the study protocol, particularly in the area of question development.”

They’re also important at subsequent phases in a trial, not just during the study design, Hinkley said. At the leadership level, at a minimum, they will guide and direct the work being done by the team, she explained, adding that not everyone that works on a clinical trial will be an SME. But, she said, “they play a large role in clinical trial oversight and are critical to their success.”

 

 

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