Navigating the clinical research process:
Experiences and opportunities
Clinical research plays a vital role in advancing medical knowledge, improving patient outcomes, and driving innovation in healthcare. Through clinical trials, healthcare facilities can identify new treatment options that improve patient outcomes.
However, some challenges pose barriers to participation. Hospitals and health systems may struggle to identify and enroll enough patients that meet study criteria, searching through disparate information systems to find relevant patient data can be time-intensive, and clinical staff may lack the time to devote to facilitating research when patient care is their top priority. Further, many racial and ethnic groups are underrepresented in clinical research, highlighting a need to recruit a more diverse group of clinical trial participants.
This white paper shares experiences and insights about the clinical research process, drawing from discussions Q-Centrix held with an associate director of clinical research operations and a research nurse coordinator, who both facilitate research at a multistate health system based in Pennsylvania; and a chief scientist at Burkhart Research Institute for Orthopaedics (BRIO), an academic research center and clinical research site based in San Antonio. This white paper also discusses the benefits and challenges associated with clinical research and shares recommendations for how hospitals and health systems can facilitate meaningful clinical research most effectively.
Benefits of conducting clinical research
Determining a study’s feasibility involves many considerations.
Research teams must consider whether the study is relevant to the facility’s priorities and whether the facility can meet the needs of the trial. This includes having sufficient staff to take on the study and having a patient population that matches the trial’s needs.
Enrollment varies widely from study to study.
An associate director of clinical research operations shared that she starts with a goal of recruiting one to two patients per month, then adjusts this number depending on the study and other factors. Minimal risk studies with short interventions are much easier to enroll patients in than higher-risk interventional studies. Depending on the study, recruitment volumes may range anywhere from recruiting 20 patients over five years to recruiting more than 1,000 patients over two years.
Data savviness is a valuable skill for navigating data-related roadblocks.
Given the challenges of relying on disparate data sources, data management skills are essential for research coordinators or other staff tasked with pulling the data required for research needs. “Having some data savviness definitely helps smooth things along,” Dr. Proffitt explained. “I think the things you can accomplish by being a little bit data savvy can really have huge gains, as opposed to doing individual chart chasing.” Dr. Proffitt said that being able to write custom queries and pull data through their EMR’s backend enables his team to obtain data much more efficiently than through manual searches.
“Having some data savviness definitely helps smooth things along.”
In a typical year, research teams may work on a dozen or more clinical trials.
The research facilitators Q-Centrix spoke with noted that their teams work on anywhere from 12 to 25 clinical trials per year. As a research nurse coordinator stated, these are typically a mix of different types of studies at different phases in the study life cycle: “For us to support the staff that we have, we should typically be actively enrolling in about five trials. We should be having about five trials that are maybe closed to enrollment but still have patients in follow-up. And then we should have about five that are on the horizon that we’re considering or being considered for.”
Study timelines can be impacted by a variety of different factors.
These include sponsor cooperation, the contracting process, a research coordinator’s level of availability, screening difficulties for complex protocols, patient interest in the study, and the perceived benefits of participation. “Make sure you understand that it can take half a year just to get [the study] on board,” said an associate director of clinical research operations. To that end, Dr. Proffitt advised that realistic timelines are key. “Have realistic benchmarks and timelines for getting contracts turned around and getting them executed,” he said.
Research teams may work on anywhere from 12 to 25 clinical trials per year.
Opportunities and recommendations
Participate in a research network.
Research networks help organizations conduct research effectively by connecting hospitals and health systems to industry-sponsored research opportunities and providing tools and services that help research teams facilitate clinical research. By joining a research network, healthcare facilities can connect with industry-sponsored prospective clinical trials matched to their needs, gain access to a broader pool of deidentified patient data, receive funded services for patient screening, use tools to assess study feasibility and identify relevant patients in real-time, rely on qualified data experts who can curate clinical data and complete data quality checks, and more. Additionally, the utilization of registry data within research networks can be advantageous, as it often overlaps up to 80 percent with primary data sets used in clinical trials, thereby significantly reducing resource burdens. This holistic approach to data integration and collaboration is precisely why Q-Centrix has launched a research network dedicated to providing healthcare organizations with these comprehensive services and opportunities.
Plan for a rotation of trials in different phases.
Maintaining a varied roster of trials six to twelve months in advance enables research teams to accommodate the different levels of time and effort these studies require and ensure a consistent and feasible stream of work. The research facilitators Q-Centrix spoke with simultaneously work on a variety of clinical trials at different stages of development, including enrollment, follow-up, and studies they are evaluating for participation.
Work closely with providers to get buy-in and assistance with patient enrollment.
This may involve participating in providers’ rounds, having monthly meetings about trials, and communicating with them in the way that is most convenient. One research nurse coordinator Q-Centrix spoke with uses her health system EMR’s secure chat function to communicate with providers about patients, as it is very accessible to providers and places less demand on their busy schedules than other forms of communication.
Make it as easy as possible for clinical staff to participate.
A research nurse coordinator mentioned that her department has a daily 15-minute meeting each morning to discuss clinical information, staffing, and research needs, providing an ongoing opportunity for research and clinical teams to keep one another informed about research efforts. Similarly, Dr. Proffitt shared that being cognizant of others’ clinical duties can help clinical staff maintain a balanced workload. “I try to be mindful of what’s going on with the research coordinator’s clinical load,” he said.
Develop a workflow.
Establishing a system for where to begin when identifying patients for a study can help streamline the process. Rather than relying solely on the protocol to understand the study specifications, an associate director of clinical research operations uses the protocol to inform conversations with study sponsors and investigators. “If you talk to the people who wrote the protocol, they will tell you where to begin,” she said. She shared that she typically begins by reviewing the protocol, then speaking with the principal investigator, and then speaking with the sponsor.
Foster a culture that centers on communication.
Facilitating clinical trials is a complex process, and questions are likely to arise on the job. Research teams should foster an environment that emphasizes communication and transparency. “Part of that culture is having mutual trust and respect, having regular touchpoints, and having transparency with what’s going on,” said Dr. Proffitt. An associate director of clinical research operations also emphasized the need for effective communication: “Having that open, honest communication is huge,” she said.
Clinical trials are instrumental in shaping the future of medicine, leading to exciting developments that continue to transform patient care and treatment outcomes. The ever-growing number of registered studies which increased by 67 percent in the last five years—suggests that many more innovations are on the way. Moreover, the FDA’s recent draft guidance on good clinical practices hints at forthcoming changes to modernize trial design and help researchers conduct clinical trials more effectively.
In the meantime, hospitals and health systems can act now to further their involvement in clinical research. Partnering with research networks, planning strategically, and prioritizing collaboration and communication are key to overcoming common barriers and facilitating research successfully. By taking these steps, healthcare facilities can drive innovation, improve patient care, and make a meaningful contribution to the broader medical community.