Episode Notes
Resources:
[email protected]: Use this email to let us know what you want to hear about.
Today’s guest is Innovaderm’s Vice-President of Clinical Operations, Kyle Given. He is recognized in the pharmaceutical and clinical research industry, bringing 20 years of experience to the table. His core strengths lie in clinical operations, central data monitoring, clinical trial management, and clinical systems.
We dive into the critical topic of choosing the right clinical research associate (CRA) for your clinical project. Our discussion will revolve around 3 key aspects:
- The evolving role and skill set of CRAs
- The importance of training and specialization
- The significance of site selection and the dynamics of CRA-site relationships
CRAs Essential Skills for Adapting to Evolving Study Designs
In the pharmaceutical industry, it is widely acknowledged that clinical research designs are becoming increasingly complex due to the introduction of new technologies and varied data capture methods. Recently, many studies have begun to incorporate decentralized concepts, where patients are either visited at home or attend auxiliary clinics for certain protocol procedures. This complexity places a significant burden on the clinical research sites, which are partners to the CROs.
In this evolving landscape, CRAs play a crucial role. They need to understand the logistics of each clinical study, a skill set that might not typically be associated with their role. They must consider the patient journey, which involves various procedures, doctor’s office visits, home devices, and medication schedules. To help a site execute and comply with the protocol expectations, CRAs must navigate these various study components effectively.
Consider the analogy of going on a vacation. If you ever traveled with a friend who meticulously planned everything, you would feel confident about reaching each destination on time, without missing any shows or dinner reservations. On the other hand, a less organized friend might lead to constant changes and uncertainty. In a regulated environment like clinical research, everything must be done as expected and defined in the protocol.
The second key skill for CRAs is understanding new technologies and data capture methods. More data is being collected, often outside of the clinic, with patients sent home with mobile devices that capture data. As we consider different types of data and how monitors need to review it, CRAs must understand various data models. It is not just about transferring vital signs from a source record to another system. They are dealing with larger and different types of data, so they need to grasp some statistical elements. While they do not need to be data scientists, they should understand the types of signals that data scientists or central monitors are looking for. This understanding will help them comprehend the implications for the site and assist the site in addressing any issues that may not be going according to plan.
Essential Skills – Critical thinking
The foremost quality a CRA should possess is critical thinking. In the early days of the industry, the CRA’s role was quite routine, primarily checking whether the site had completed specific tasks. However, the landscape has changed significantly with the availability of various types of data reviews.
The focus has shifted towards centralized data monitoring, which involves real-time data analysis using different analytics, trending, and pattern recognition. Before a CRA even visits a site, they need to comprehend all this information and apply it to the specific site’s setting. This process necessitates critical thinking.
CRAs must understand the nature of the data, how it is collected, and where potential system failures might occur. They should be capable of applying a series of mitigation or remediation steps to address problems as they arise. This level of critical thinking is essential. It is no longer sufficient to merely review the data; the goal is to assist sites in improving their performance.
What is the impact of specialized training for CRAs?
Training is a crucial aspect for all roles in the clinical trial industry. Innovaderm takes pride in the significant investment made in the training of CRAs and all other central roles involved in the clinical research process. The medical monitoring team has devoted considerable time to develop a comprehensive 16-part training program focused on dermatology. This program covers various indications, etiology, manifestations, and current treatments, providing our CRAs with a wealth of knowledge.
This knowledge enables our CRAs to act as trusted advisors when they visit sites. It is vital to instill confidence in the sites by providing accurate information. This allows them to adjust their behavior to align with expectations. The term “monitor” has often been used, but it carries a negative connotation, as if they are penalizing the site for every mistake. The goal is to engage sites by providing the right information and knowledge, helping them improve their study conduct.
That trusted advisor model is essential, and it can only be achieved through thorough training and awareness.
What problem Solving and Root Cause Analysis Play in This Process?
When considering the required skills for CRAs, it is crucial for them to adopt a multidimensional approach to any situation at a site. They need to understand the data and be capable of critical thinking. This is all part of equipping them to accurately assess a site’s activities.
A couple of brilliant biostatisticians in the past who always emphasized that most sites do things correctly most of the time; however, when they do make a mistake, they tend to repeat it. This is where the concept of root cause analysis comes into play. It is essential to understand what is really happening. We cannot always resort to simply retraining the site. There might be a technology issue, or there could be an underlying procedural issue at the site. These factors need to be understood in order to apply the correct mitigation strategy to address any risks that might become apparent in the data visualization or operating model.
The process comes full circle: starting with risk awareness, followed by risk observation, identification of the risk’s root cause, and finally, rectification of the identified risk. This comprehensive approach to problem-solving and root cause analysis proves to be essential for CRAs.
How does the CRA’s Knowledge of the Site Performance Play in the Site Selection Process
The role of a CRA’s knowledge in the site selection process is both critical and essential. This knowledge is leveraged in 2 key ways. Firstly, it involves collecting the right data in each study to quantifiably assess performance based on historical work. Given the opportunity to work with many of the same investigators in this therapeutic space across multiple studies, it is crucial to capture the right type of data on their performance in historical studies. This data can range from the number of protocol deviations they have generated in the past to the consistency endpoint data across the individuals administering it at the site. These factors serve as strong indicators of how the site might perform in the future.
However, data only tells part of the story as things can change. The other part comes from the subjective experience of working with the site. Factors such as their responsiveness, their ability to take direction, and their willingness to accept their faults and work to improve them come into play. These subjective elements often emerge more through an anecdotal feedback mechanism.
When entering each study, the site selection team collaborates with clinical operations to present a site list, providing an opportunity to offer constructive feedback. While the aim is not to eliminate sites, it is important to be aware of where a site may need help in the future. This knowledge can then be utilized to start the site off on the right foot if they have had difficulty in a specific area in the past.
Furthermore, sites are requalified for every study to ensure nothing substantial has changed whether that is their facilities or staff turnover. It is always important to consider these factors because historical performance does not always predict future performance. Thus, it is a constant, ongoing process that needs to be facilitated.
Essential Tools for CRAs
Essential tools for CRAs include a clinical trial management system (CTMS) and a trial master file (TMF). The CTMS tracks all the various actions and activities at a site level, such as how much data was reviewed, how many action items are being tracked, and how to address protocol deviations. The TMF, on the other hand, houses all the documentation that serves as evidence of what has been done in any clinical trial.
These tools, while essential, are often manual in nature and require significant effort from the CRAs. As artificial intelligence advances, it may help CRAs in documenting and maintaining data consistency, and in capturing data more effectively. Recently, a new CTMS and electronic TMF (eTMF) were selected, with a focus on building efficiencies into the process. The aim is not just to input data into the systems, but also to extract data for managing the next set of activities.
Another important data visualization tools is Power BI. These tools pull data from various systems and present it in a way that allows a CRA to see the volume of work at each of their sites and identify potential risks. This snapshot view of their world greatly aids in planning for the next site visit.
In this way, the data captured in the CTMS provides feedback that can be used for the next visit, creating a continuous cycle until the end of the study. This cyclical process is an ongoing part of a CRA’s role.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights
