5 Clinical Research Trends Emerge at ACRP 2018

ACRP 2018 Attendees Discuss Emerging Trends in Clinical Research

ACRP 2018 Attendees Discuss Emerging Trends in Clinical Research

Whether it was during a session, a specialized workshop, or a networking break, several interesting themes dominated the Association of Clinical Research Professionals (ACRP) 2018 annual conference held at the Gaylord National Resort & Convention Center in National Harbor, Md., in April. Here’s a closer look at five key takeaways.

#1—Professional Competency is Gaining Traction as it Moves from Theory to Practice

Don’t get burned by relying on tenure when making new hires, said Jill Matzat, RN, BSN, CCRA, owner of Medical Research Management and CRA Solutions, Inc.

“I tell sponsors it’s not about one-to-two years of experience, it’s about a skillset,” she said during her session on “Smart Monitoring: Is My Monitoring Adequate?” Good monitoring requires “critical thinking” and must be about more than source documentation, Matzat added.

What does Matzat look for when hiring? “Competency training, Good Clinical Practice knowledge,” and good old-fashioned organization and time-management smarts. It’s important for a clinical research associate (CRA) to have a real-world sense of how long a given task will take and set their priorities accordingly, she said.

The demonstrable value of competency is obvious to the leadership at Duke University Medical Center. The innovative practice has organized some 180 formerly sprawling and sometimes vague job descriptions and honed them down to a dozen, based on professional competencies and clearly stated expectations. All told, Duke mapped more than 700 people.

“I think we owe it to our patients to be very transparent about who’s doing what, how they’re doing it, [and to be able to demonstrate] that we have the most qualified people working in clinical research,” said Denise Snyder, MS, RD, LDN, associate dean for Clinical Research at Duke and a member of ACRP’s Workforce Innovation Steering Committee (WISC).

There are many benefits when hewing actual competency to specific roles, starting with recruitment and retention. Doing so also provides a clearer career path, Snyder said.

On the corporate side, AstraZeneca is actively leveraging new core competencies to better train, retain, and inspire clinical trial practitioners to new levels of quality in every aspect of its clinical trials, said Doug Schantz, MICP, BA, executive director for clinical operations.

Rejecting the current model of tenure-driven career advancement, Schantz said core competencies are giving members of AstraZeneca’s growing trial workforce new opportunities to develop career paths that will maximize their skills and professional opportunities. “It must be frustrating and dissatisfying to have to wait two years” when you know you are already fully prepared to take the next step in your career, he noted.

Over the past year or so, AstraZeneca has been bringing its clinical research coordinators (CRCs) in-house, and plans to bring in some 20 monitors in 2018. It will use standards-based competencies to assess the performance of new team members, Shantz explained. Competencies make it much easier to onboard college graduates or other entrants new to the industry, he said. “It’s a great framework,” he added.

However, competencies are not about identifying professional failures, ACRP Workforce Innovation Officer Beth Harper told attendees. “They are about identifying gaps” and helping CRCs find the right kind of training that will help them learn the new skills and, if it’s their goal, move on to the next level in their career path, she said.

With established competencies, “you learn what you need to do to prepare for the future,” Schantz added, also stressing that competency-levels are about advancing careers and not punishing anyone for knowledge gaps. “I wish I’d had this list of competencies years ago when I entered the field to help me identify what I needed to learn,” he noted.

“Being paid to learn is a big inducement for our newly emerging talent coming into professional careers” when trying to entice the best of the best in the workforce, said Jennifer Byrne, former CEO of PMG Research and cofounder of Greater Gift. “ACRP has made a commitment to these competencies,” she added.

The point is clear: Competency, not tenure, should be the litmus test for clinical trial professionals, a growing number of experts agree. The challenge is developing and promulgating such standards. That’s where the Joint Task Force for Clinical Trial Competency (JTF) comes in.

In today’s clinical workforce, people are “hired or promoted based on whether they’ve had two years of experience, as opposed to how competent they are,” noted Stephen A. Sonstein, PhD, director of clinical research administration at Eastern Michigan University and one of the leaders of the JTF. The JTF is a driving force to change that dynamic.

#2—There is a Growing Desire for Industry Collaboration

Better communication between sites, sponsors, and contract research organizations (CROs) can improve clinical trial quality “from start to finish,” said Jeff Kingsley, DO, MBA, CPI, FACRP, chief executive officer at IACT Health, immediate past chair of the Association Board of Trustees for ACRP, and a panelist for the ACRP-Avoca Quality Consortium’s 2018 Quality Congress, a full-day program held in conjunction with ACRP 2018.

For example: Many potential protocol design problems can be nipped in the bud with a healthy dialogue. Kingsley recently had to address a “protocol violation” because an EKG reading had been done on a trial patient before the lab draw. “Most [protocols] don’t even specify the order [of tests] because it’s irrelevant,” Kingsley said. On the relatively rare occasions when it is spelled out, it’s for the opposite order: lab draw, then EKG.

In this case, better communication between site and sponsor would have prevented that unnecessary, time-wasting setback. However, in some cases, Kingsley and his team are not even able to get the sponsor’s contact information because the CRO wants to discourage direct communication. Part of the problem, Kingsley believes, is the “sentiment” that CROs feel like they need to be the “buffer” between sites and sponsors. “I understand why they think that, but it’s unnecessary,” he said.

Unfortunately, these relatively minor, and often avoidable, protocol violations generate “noisy” data that can give the U.S. Food and Drug Administration the mistaken impression that a trial is having significant problems, Kingsley said.

Each trial player can and should share their expertise with each other, Kingsley stressed. For example, he was involved in a trial of a therapy for a kidney condition in which the sponsor extended the age criteria for participants in the hopes of improving its pool. The problem? They were unable to find older patients with healthy enough kidneys to qualify, wasting time on an ultimately ineffectual strategy.

“They have no clinical experience,” Kingsley said of some sponsors. An experienced clinician would likely have recognized the problem before it got very far.

Kingsley’s final analysis? “Communication would have fixed it all.”

“I can’t tell you how many times professionals representing each part of the clinical trial process have told me they wanted to foster closer relationships with their colleagues,” added ACRP Executive Director Jim Kremidas, who also participated in the 2018 Quality Congress.

#3—The Workforce is Hungry for Career Mapping and Standardization of Roles/Onboarding/Training

A lack of CRC job title consistency “blurs” the equation on both sides of the interview and hiring process, said Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC, a strategy executive with Medix Clinical Research, member of the WISC for ACRP, and speaker at ACRP 2018.

In today’s clinical trial landscape, “sites are often left to themselves” to interpret various job titles without much confidence that the title reflects any actual skillset, Downhour said. She recalled her experience at a site trying to recruit and maintain the best staff, noting “We had to be creative with titles to compete with others” going after the same talent pool.

The result? Titles can become almost meaningless and arbitrary. That doesn’t do anyone any good, Downhour said.

For example, while many CRCs are nurses, they often aren’t trained for their role in clinical trials. “Nursing research is very different from clinical research,” Downhour said. Unfortunately, that contributes to a “lack of awareness” among nurses when it comes to a clear career path in the clinical trial industry.

“Whether the time is right…is really about determining what is right for you,” said Marian Fisher, RN, CCRC, a senior CRA with Boston Scientific, who co-presented at ACRP 2018 on “Career Progression in Clinical Research: Transitioning from Site CRC to Sponsor CRA.” “I would not say moving from [a CRC to CRA position] is necessarily a progression…but a shifting,” she added. Noting that most employers are looking for at least two years of relevant research experience as a qualification for a CRA position, she added, “The key is you need to be good where you’re at [first].”

Fisher’s co-presenter, Thomas Boothby, a CRA II with Boston Scientific, agreed, saying, “You have to know the regulations to know what a coordinator does before you can take the next step” to a CRA role. Making that move is not “a given,” or something that everyone is entitled to, he explained.

It’s also important for CRCs who are considering becoming CRAs to recognize the different types of monitoring being done in the drug and device development industry, the presenters said. Beyond traditional onsite monitoring by making visits to study sites, the nuances of risk-based and central monitoring vs. remote monitoring and in-house CRA activities can be difficult for people not already in those roles to understand.

A perceived lack of professional advancement and career development opportunities are the two biggest factors driving clinical trial professionals to seek employment elsewhere, according to a new survey by SCORR Marketing and Applied Clinical Trials. With a little more than 40% of respondents reporting they were currently looking for a new job, nearly half said a dearth of professional advancement was the single biggest factor beckoning them out the door. Interestingly, inadequate salary was cited by a bit more than 20%, suggesting that job satisfaction, fueled by a clear career path, is more important when trying to reduce churn in a competitive market.

Nearly 60% of respondents to the survey were members of an industry association or organization; ACRP was the top-ranked organization, with about one-third of those respondents saying they were members.

#4—The Clinical Trial Workforce of 2028 Will Look A Lot Different than It Does Today

Buckle up, because the clinical trial industry is on the cusp of seismic change that will “have a huge and profound impact on all of you and the work that you do,” Kenneth Getz, MBA, director of sponsored research programs and a research associate professor at the Tufts Center for the Study of Drug Development, told attendees of the ACRP 2018 meeting.

The days of process driving clinical trials are just about over, Getz said. “We are undergoing a course correction in the way we develop drugs and the way we conduct clinical trials,” he explained. “We’re moving away from this process-oriented approach to supporting clinical research, and more to a data-oriented approach with the patient at the core. We have spent the last 30 or 40 years thinking about the clinical trial as a process to be managed, and now the data [are] actually changing our entire orientation.” The new drivers? Patient data and patient engagement.

Clearly this is not your grandfather’s CRC, other experts chimed in about how roles on clinical trials teams will or should change in the near future.

“It’s time industry adopted a competency structure to reflect the new demands on CRCs,” ACRP’s Harper said.

“We keep talking about the future, but the future is now,” added Susan Romberg, senior vice president for global clinical operations with Premier Research. “We don’t want jobs to be based on tenure anymore. I’m a big fan of what ACRP is doing with the Core Competencies [for different clinical research team roles].” If anything, Romberg said she’d like to see ACRP moving even faster.

Indeed, the CRC role is evolving so rapidly that it’s hard to keep up, Harper noted. For example, ACRP’s CRC mapping found some 114 different tasks a CRC is “likely to have to be proficient in…[but] is that [a] realistic” expectation, Harper said.

ACRP is working with the aforementioned JTF to find ways to train professionals with such disparate skill set demands, Harper said. “Do we need to start thinking differently” about defining roles and responsibilities for CRCs? “The same thing goes for CRAs,” she added. The CRA of the past was involved with data monitoring and field analysis, among many other expectations. “Those are all very different skills.”

In 2013, the JTF developed eight competency domains for creating a professional competency framework for the clinical research enterprise. These competencies are recognized by ACRP and many other groups nationally and internationally and have been used as a guide in preparing professionals for achieving certification in clinical research.

#5—Clinical Care is Already Beginning to Drive Clinical Research

“I think it is a very opportune time for the clinical research community to expand the way we think about the overarching value of clinical research,” said Greater Gift’s Byrne. Her organization offers a specific program whereby a child in a third world country receives a potentially lifesaving vaccine in honor of a volunteer who has participated in a clinical trial. She advocates promoting the concept of clinical trials as another way to further empower patients through the choice of clinical research as a healthcare option

Byrne is clear about drawing some boundaries and applying definitions to the discussion. “When we talk about clinical research as a care option, we’re not advocating that clinical research is about treatment, but rather should be amongst the menu of options for both healthcare providers and patients” she said. Irrespective of treatment outcomes associated with clinical trial participation, in my experience, clinical trial participants receive “white-glove” health care, become more knowledgeable about the specific condition under study and overall more interested and involved in their overall well-being.

Tufts’ Getz agreed. The pharmaceutical industry funds most clinical trials, he said, and that puts it in a great position to drive clinical research into a clinical care environment and facilitate the clinician’s role as a support resource for clinical research activity.

More Highlights from ACRP 2018

 

Friday, April 27

Site Voices Critical to Improving Clinical Trials

Is the CRC Job Structure Falling Behind the Times?

Building a Better Site Budget is Key to Ensuring Trial Success

Catching Up with the Evolving World of Project Management for Trials

Are You Giving Patients a Compelling Reason to Stay in Your Trial?

Saturday, April 28

Industry Leaders Praise Role of CRC in Clinical Trial Improvement

Sponsors Often Judge Sites by How They Treat CRCs

Listening to Patient Voices Will Lead to Better Trial Registries

NIH Promises Stronger Clinical Trial Oversight

Sunday, April 29

Pay Attention to ‘Research Barriers’ When Recruiting from Underrepresented Groups

AstraZeneca Harnesses Core Competencies to Drive Quality, Create Career Paths

Let Skillset, Not Tenure Inform Hiring Decisions

No ‘One Size Fits All’ for PI Compensation

Research Professionals Experience Trials from the Other Side

Monday, April 30

Clinical Trial Professionals Should Wear Their ‘Halo’ Proudly

FDA’s Burrow Offers Insider Inspection Tips

The Lead Monitor Role Steps into the Spotlight