Clinical Researcher—February 2018 (Volume 32, Issue 2)
When Katherine Pryor, MPM, CPM, was interviewing for her first job in project management, the hiring manager asked a simple question: “How are you at herding cats?” She laughed, of course, coming from a clinical research background and familiar with how to juggle competing needs and personalities.
Pryor landed the job, but after five years working in project management, including her current role with Atlantic Research Group, she understands the question at a deeper level. In fact, several Association of Clinical Research Professionals (ACRP) members contacted about sharing their experience in project management for this article were familiar with the metaphor. As one put it, “It’s more like herding feral cats.”
Many project managers endure what can be uncomfortable experiences—moments when people behave in wild, untamed, and sometimes brutal ways. How to deal with such situations productively is one reason they gather in professional communities.
The new Project Management Track at ACRP 2018 (the Association’s annual meeting and exposition upcoming in April) will bring together veteran practitioners, people new to the field, and those interested in transitioning into project management to share experiences, strategies, and cat-herding techniques. “I love the fact that project management is getting more attention” at ACRP, Pryor says.
For people who have been successful in study coordinator positions, project management is often the next logical career step. For those new to the field, or people now working in project management who have no formal training, educational programs like the ACRP track deliver the language and concepts of project management, and perspectives on the field from seasoned practitioners.
Best Practices Shared Across Industries
While professional development in project management comes from a variety of sources, there is an advantage to learning directly from colleagues in clinical research. Basic project management frameworks are the same from industry to industry, including in information technology—where the field has its roots—the construction industry and others, says Romiya Barry, Manager of Clinical Operations at AngioDynamics.
“On a high level, best practices can be shared across industries,” Barry says. There is a common body of knowledge that guides all professional project managers. However, when it comes to clinical research, the differences are profound. “We work with patients, not bricks,” Barry explains.
The ACRP project management track is “field specific and career specific,” Barry adds. Considering all the tasks a clinical research coordinator (CRC) handles on a daily basis—logistics for securing global shipments of investigational products, training site personnel, engaging with investigators, etc.—much of what they do involves project management. That’s why they often move into project manager roles.
Too often, however, CRCs advance and are asked to handle tasks with higher levels of complexity and no formal training on what should go into a well-managed project. Many of them may execute well at the site level, but lack the knowledge to implement projects at a larger scale.
Budgets, timelines, invoicing, action items—these words define some of the activities on any given day for a project manager. For most CRCs positioned for advancement into project management, as well as project managers who are new to the field, the methods for managing these tasks are not readily apparent, Pryor says.
Clinical researchers are good at thinking about what’s going on at the site level. To achieve success as a project manager in clinical research, you need both the site awareness and the functional abilities to make sure everything works at that higher level, says Pryor, who went on to earn a master’s degree in project management.
Becoming the “Accidental Project Manager”
Barry, who started her career working in a lab, considers herself an “accidental project manager”—a term that is used frequently in clinical research, she says. It wasn’t the career trajectory she had planned, but it became a good fit based on her science background.
“I was used to the natural order and the process of managing all the steps in a research project,” Barry says. At the bench level, “if you run out of something for your experiment you have to go and get it yourself.”
For many clinical research professionals, the scientific method translates well in a project management setting. For Barry, a science background laid the foundation for roles in regulatory affairs and clinical trial operations, and for her continuing education (she is currently in a doctoral research program at The George Washington University in Washington, D.C.).
As a scientist, you “see the impact of someone else getting their job done and the impact it has on your work,” Barry says. This makes people working as CRCs or in similar roles ideally suited to transition into a project management career.
As new entrants join the field and participate in learning opportunities like the project management track at ACRP 2018, veteran project managers such as Barry and Pryor join these sessions to stay on top of an evolving industry, stay in touch with colleagues who can bring new perspectives, and give back to the professional community.
Economic Efficiency in the Device Industry
Among other topics, the project management track offers a session in protocol development for device studies. For those with a history in drug research, hearing from experts about what’s new in device trials may open new opportunities, especially given the growth in drug-device combination studies.
One trend in the medical device industry is the growing sophistication of research into economic efficiency, according to Victor Chen, Director of Clinical Affairs at Align Technologies. In the past, these efficiency requirements were less rigorous and smaller in scale. Plus, they were more immediate, says Chen, one of the speakers in the ACRP project management track.
Traditionally, the main question addressed in efficiency studies was, “What do I save for you, the doctor, in this procedure,” Chen says. Today, studies of economic efficiency have moved to a different level. “While you’ve always tried to show that you are a better value, now you have to quantify that value with a specific patient outcome,” Chen explains.
In partnership with Christopher Cain, Vice President of Clinical and Regulatory Affairs at Corindus Vascular Robotics, Inc., Chen will present on “Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs” at ACRP 2018. Rather than just proving immediate value, device companies need to show how products will save money over longer periods such as five years.
“The value then was more for the doctor’s sake,” Chen says. “Now it’s more for the hospital system’s sake.”
One of the challenges in measuring the effectiveness of a device is the variety of procedures. In pharmacoeconomic studies of new drugs, there is little variation in terms of drug administration. With a device study, “there is a human involved,” Chens says. “Doctors do things differently. There are different workflows. The way they discharge is different. So overall, the benefit may be localized. Due to differences in standard of care, the measures have to be regionalized. Something that is of value in one region may not be in another.”
Another variable to consider in device economic efficiency studies is the environment in which the study is conducted. A university research team may require more oversight to ensure efficient conduct compared to one operating in a private setting, Chen says. The specific protocols established within universities cause this variability. In recent years, however, standards from site to site have become more universal because of regulations, he adds, lessening the difference between private and public research sites.
In order to meet patient outcome goals, project managers who develop protocols for device or drug-device studies need to account for economic efficiency in new and more innovative ways. Those who understand this protocol development process are better equipped to effectively lead projects and deliver them on time, within budget, and with the required degree of quality.
The movement toward tying device value more closely to patient outcomes is driven by costs, of course; however, it can be considered part of the trend in patient centricity. For most patients, “quality of life” means fewer days spent in the hospital and fewer of their own dollars spent on healthcare. New devices that account for these values support patient desires.
Moving Beyond Patient Centricity to Partnership with Patients
Barry has a more nuanced view of patient centricity. “We are going to stop seeing the term ‘patient centered’ used so frequently,” she predicts. “That is a static view, with the patient in the center and everyone else working around them. That’s the old paradigm.”
Barry sees a future with more clinical studies conducted and framed in full partnership with patients who are viewed as shared stakeholders in the outcomes, rather than simply being approached as a population required to be involved in the research. This change is driven by advocacy organizations that are empowering patients to take a more active role in research.
In the new paradigm, clinical research project managers need to think more about patients’ needs in addition to those of sites and sponsors, Barry says. Asking patients what they think of a draft protocol is “nice,” says Barry. “But you really need to consider aspects of patient care that are outside your primary interest in an endpoint.”
The central question has shifted. As Barry puts it, “It’s no longer ‘how can the patient make the study work for the company?’ It’s ‘does this study fit into the patient’s life?’” Regulatory guidance from groups such as the U.S. Food and Drug Administration’s Patient Engagement Advisory Committee for medical devices are fostering this change in clinical research.
More Coming Down the Tracks…
Patient perspectives, the transition from CRC into project management, economic evaluations of device value. This is just a small sampling of the topics to be discussed in the project management track at ACRP 2018. The six presentations spread over three days all touch on the three primary constraints for every project manager—budget, timelines, and quality. In fact, organizing the session itself has been a small feat of project management.
Pryor uses another metaphor to describe the practice in clinical research. “The project manager is like a train conductor,” she says. “You need all the cars, of course. But also, do you have enough fuel? Are you going in the right direction? What do you do if an avalanche hits and you get rerouted?”
Consider attending ACRP 2018 to explore such questions with attendees from the world of project management, and from many other specialties in the clinical research enterprise, at the Gaylord National Resort & Convention Center just outside Washington, D.C. at National Harbor, Md., April 27–30.
Matthew Harrington is a freelance writer and consultant with Worldwide Clinical Trials.