Insights from Kate Sheeran, Director of Research at Q-Centrix
Effective clinical research is teamwork. The curious who ask the research questions. The logistical minds that design the study and gather the appropriate sample sizes. A partner who understands the data, collects it accurately, and knows how to make it usable.
The challenge of balancing these groups and their requirements in a fast-paced environment are an inherent part of any clinical research project. From regulating demands on their teams, to recruiting the right patients, creating the right trials, and handling data appropriately, it is no wonder so many researchers find the challenges overwhelming.
As Director of Research at Q-Centrix, Kate Sheeran works with clinical researchers across the country to understand the most pressing clinical data management needs in research and build solutions that advance medical knowledge and improve patient outcomes. Here, we begin to explore common challenges through Kate’s perspective, why they exist, and the innovative solutions she’s creating to overcome them.
Key points:
- Clinical research leaders must balance diverse demands, master communication, and embrace a nuanced definition of diversity to navigate the increasing complexity and speed of trials.
- Effective communication bridges gaps between practitioners, patients, and sponsors, providing perspectives that enhance patient enrollment and study design.
- Leveraging enterprise-level clinical data technology empowers researchers to conquer complexity, optimize processes, and revolutionize data management.
The great balancing act: Managing multiple demands
Each trial comes with its unique set of intricacies, compelling coordinators and decision-makers to wield adaptability as their most valuable tool. No two days, or two studies, are the same. This is both the allure and aversion of any research role. But to Kate, the common challenge that unites every study is the struggle for balance.
Clinical research coordinators need to be adept at juggling diverse responsibilities from their practice, the facility they serve, sponsors with high expectations, and patient needs. Effective communication and a nuanced understanding of every role are crucial in this endeavor. Kate shares a recent experience highlighting this reality,
“I spoke with a bench scientist embarking on her first human study of a compound she had developed in her lab. She candidly expressed what many of us already know – research is an immensely challenging experience.
We delved into the hurdles she encountered – the intricacies of communicating with the Institutional Review Board, data collection across siloed areas, and the complexities of assembling the right team.
To succeed, clinical researchers must possess a strong grasp of their protocols and understand their patient population thoroughly. Proper planning, coupled with adaptability and the right set of tools, allows coordinators to manage workloads effectively and find the balance necessary to serve everyone involved in the study.”
Kate supports researchers through conversations such as these frequently, and she’s gained key insights that can help every researcher make progress despite the vastly different work they do: mastering communication, embracing new approaches, and leveraging technology wherever possible.
1. Master communication to gain perspective
Communication is the linchpin that connects practitioners, patients, and sponsors to coordinate an orchestra of tasks. Having served as a research coordinator, nurse practitioner, and now in her current role, Kate has witnessed first-hand the far-reaching impacts of effective communication in addressing research challenges across the board.
Staffing
Establishing communication with team members is crucial for getting an honest perspective about the flexibility required in staffing. Finding the perfect balance of staff and studies is a moving target, but maintaining open communication and understanding individual site needs can optimize resource allocation.
Patient enrollment
Fostering relationships with practitioners, reminding them about ongoing studies and keeping them apprised of study criteria is crucial. Patients come and go every day. Your physicians will need regular communication to ensure their knowledge of the potential treatment adjustments.
This ongoing communication streamlines the process of patient enrollment. In Kate’s words,
“You need to communicate with your providers, reminding them regularly about your open studies. Remind them of the criteria so that as they are seeing patients, as conditions change, or as patients need new therapy, you can get them enrolled. That constant communication can feel excessive, but I promise you it is better to overcommunicate and have consistent enrollment.”
Study perspective
Establishing rapport with monitor personnel, sometimes called site excellence partners, will also provide coordinators with unique insights. The role’s name underscores the collaborative nature. While it can be challenging, building these relationships and engaging in communication that delves into performance across various sites offers a broader perspective that can help further guide coordinators.
This perspective becomes a lens through which you can assess your own strategies and determine if difficulties stem from internal processes, or if the study inherently poses universal challenges.
By tapping into that information, coordinators are better equipped to fine-tune their approach, ensuring that their endeavors are aligned with both sponsor expectations and the evolving dynamics of patient bases and clinical research itself.
“I was always friendly with my sponsor reps because it allowed me to better understand their expectations and how the study was going at other sites. I would ask if other sites were struggling to enroll, and if so, what criteria were most challenging. That perspective allowed us to evaluate our performance objectively and make necessary adjustments to enhance our trial’s success.”
Through open dialogue and a bird’s-eye view of the research landscape, coordinators can cultivate a balanced approach that pushes the study forward while meeting demands. Kate’s insights align with findings from a recent white paper, which highlight the need for open communication channels to overcome barriers and ensure optimal patient participation.
2. Embrace data-driven dialogue on patient pool diversity to guide study options
In the pursuit of advancing medical knowledge, the enthusiasm to contribute can sometimes lead to an inadvertent oversaturation for a specific indication. The consequence? Diluted enrollment rates compromise the potential success of each study.
Kate shares that proper assessment and pre-screening for potential patients is pivotal to fostering productive conversations with study sponsors and internal leaders.
“Before committing to a study, assess the studies you already participate in, compare this to what the new study requires, and then go back to your data. When we work with partners on this, we look in their EMR to filter for eligible patients.
Out of the 40 potential individuals, 25 of them already have taken exclusionary medication. Then, out of the 15 remaining, five of them do not wish to participate. We support this work through our tools and our expertise so that you can bring the data to the sponsor and determine whether that study is right for you and what alternatives better support your patients.”
This data-driven dialogue not only highlights a meticulous approach but aids in making informed decisions that prevent oversaturation. Embracing the diversity of your patient pool and wielding it as a catalyst for expertise enables an intricate understanding of alternative approaches. In turn, each study receives the attention and competence it requires.
Understanding that you cannot say yes to every study is paramount. While the desire to contribute is commendable, strategic selection is essential. By embracing new approaches—for example, observational studies, or variations in BMI criteria—Kate helps researchers identify opportunities to offer studies that cater to specific patient profiles without overwhelming their patient pool.
“As clinical researchers, you connect studies to patients and contribute to groundbreaking discoveries. Having the data to master the art of adaptation and strategic selection makes all the difference, and that is what we are focused on bringing to the industry.”
3. Navigating increasing complexity and speed with tech-powered solutions
The relentless pace of clinical trials, magnified in the aftermath of COVID-19, push coordinators like Kate to find new methods of optimizing processes.
“Since I started research 20+ years ago, the complexity of the labs we are drawing has increased exponentially. The processing can be complicated, and most coordinators must do it all themselves.”
The COVID-19 era showcased the remarkable results of dedicating every resource to a single study, but the truth remains that not all studies can be accelerated in the same manner. Nuanced patient eligibility criteria, study design, and the study disease profoundly affect the feasibility of this breakneck pace. However, the right tools do allow for incremental gains in navigating the complexities of clinical research.
Structuring the unstructured
The intricacies of clinical trials are often compounded by unstructured data—information that is challenging to capture within conventional systems.
“We are being asked to find ways to make data collection easier, more efficient, and more connected. The reality is, most things that “can’t be done”, only appear that way because the information that is required is unstructured. Q-Centrix already has solutions to those tough challenges I faced in my other research roles.”
Emerging solutions like those offered by Q-Centrix strive to structure the unstructured, transforming disparate pieces of information into cohesive datasets. This revolution simplifies the collection process and enhances the quality and completeness of the data gathered.
Conquering complexity in a tech-powered future
From managing data and optimizing enrollment to facilitating communication and bridging gaps between systems, technology offers clinical researchers a solution to confront the dual challenges of complexity and speed.
“My proudest moment in research roles so far was when we integrated a platform to help us collect patient outcomes for orthopedic surgical procedures. I spent a year working with different IT teams to help bridge the gap and build the tools we needed to make it easier for everybody in the practice to connect patients to their surgery outcomes in one centralized location.”
As Kate’s journey exemplifies, understanding and harnessing the potential of technology are essential skills for modern clinical researchers. Organizations like Q-Centrix are paving the way, offering solutions that bridge the gap between clinical expertise and technological prowess.
“We know clinical data better than anyone, and we have a proven track record of building the technological tools clinical data experts need because we speak both IT and clinical data fluently. That is so rare, and it allows us to make the most effective tools available.”
While some aspects of a study’s timeline may be beyond control, clinical researchers can still strive for efficiency. Utilizing advanced technologies, such as enterprise clinical data management tools, can streamline data collection and processing. Above all, researchers must prioritize accuracy and adherence to protocol over rushing through the process, ensuring reliable and valid results.
Kate’s vision for the future of clinical research
According to the 2023 NSI National Healthcare Retention & RN Staffing Report, research roles have one of the highest turnover rates in the industry at 30%. By empowering researchers with the resources they need, Kate hopes to attract and retain more passionate professionals to continue the advancement of medical knowledge and improve patient outcomes.
“Research is challenging, and as a result, many people do not participate long-term. Whether it is a physician who had to do a research project as part of their medical education or a nurse practitioner who did not have great support when they worked as a coordinator – I do not want people to give up on research. By giving them the tools, support, and technology that Q-Centrix offers, and showing them that it is possible to use the data they have, we can make research an even more rewarding field.”
As healthcare facilities endeavor to enhance patient outcomes through clinical trials, aligning perspectives from seasoned experts like Kate and other comprehensive resources will undoubtedly pave the way for innovative and impactful clinical research practices.