BioPharma studies are as vast as they are pioneering, with many different teams within many different groups across many organizations all playing a part in executing the work.
With such extensive teams working on these trials, not to mention all of the many different vendor teams involved in the various aspects of executing studies, there could be unintentional gaps in ensuring the quality of the study.
Some studies may be deemed a success and some a failure, but all studies are a success if the data quality is high and the study is conclusive.
High quality data means clinical research teams are provided with the true science-based facts they need to be able to ultimately move forward and make the best, most informed decisions for not just the study and molecule but most importantly for the entire patient community. What does this look like in reality? How can such sizeable teams, many of which are working across multiple locations, and many more are working remotely right now, maintain data integrity?
Senior Account Director, Dr. Holly Gratkowski, shares some of the measures that can help ensure entire teams keep quality at the forefront of their mind.
Understand your Contribution to the Bigger Picture
With such vast teams working on trials, it can be difficult for all team members to see where they fit alongside their colleagues and visualize how their actions are contributing to the end goal.
It’s not uncommon for people to be task-orientated when they are behind the scenes and setting up study data or performing an individual element of an analysis. But the actions they make on a daily basis do go hand-in-hand with influencing the overall objectives of the study and impacting quality. Not only is it important for the individual to understand how that work contributes to the success of the study, but it also inspires the type of passion and motivation that encourages breakthroughs in thinking.
If we take Key Risk Indicators (KRIs) as an example, we can appreciate just how crucial data can be. KRIs offer a prioritized, risk-based approach to monitoring trials, as advocated by the FDA and ICH. As such, when it comes to programming KRIs and inputting the data it is vital that the team member not only understands the data that is entered but also how it is collected, in addition to the goals and reasons behind the KRI. Being cognizant of the wider impact of what the data actually means and having a constant focus on the importance of quality data for the overall study and real-world impact leads to better quality data overall. Being mindful of the end goal is key – it is not a task in isolation but a contribution to a potential ground-breaking medical study. Quality is critical – it is THE most important factor in clinical studies.
Notice the Anomalies, and Act on Them
Risk-Based monitoring allows organizations to identify where there might be inconsistencies or quality issues. Being able to identify those risks is an important first step. Understanding of what has or is causing this risk to occur is crucial in determining appropriate actions. The actions come from a true understanding of being able to relate the anomaly in the data to the root cause while considering what will have the most impact on the quality of the study data. This again reinforces the need for all participants across the clinical study spectrum to understand how the individual’s piece fits into the bigger picture. Empowering individuals to critically think about what is in front of them and not just an individual goal is key to identifying the appropriate actions.
This ties in with team members understanding their contribution to the bigger picture and recognizing that they are feeding into something that’s much larger and geared towards helping people.
Regularly Communicate with Each Other
It’s important teams have regular conversations with each other and communicate key milestones that are about to be reached or have been reached within studies. For instance, it could be as simple as letting everybody know the first patient is in.
These updates can be shared on Slack, instant messaging or via other comms channels. The key is that everybody’s kept informed of what’s happening when it’s happening. Sharing key milestones can help generate excitement around studies and make everybody more engaged with their work overall. The excitement drives passion and the passion drives motivation and the motivation drives inspiration for new ideas.
Give all Team Members a Voice
In addition to sharing updates, it’s essential regular team meetings are held, especially now, when it’s not so easy for people to meet face-to-face because they’re working remotely.
These meetings should be used to allow team members, who are working at all levels, let everybody know what they are doing. The person who’s doing the actual role is going to be the most knowledgeable, so having a conversation about what they are seeing and what they doing in the study and how their role relates to the end goal is incredibly important. (A quick note about virtual meetings: make sure everybody attends them and that they are fully engaged, i.e. their cameras are on and they aren’t multi-tasking).
Here at CluePoints, we see the value of making sure everybody clearly understands their role and how they contribute to the bigger picture. Our team members proactively contribute and interact and everybody’s thoughts and comments are welcomed and shared at every level. Inspiration comes from everyone, and everyone can and does make a difference.
Individual Understanding + Big Picture Thinking = High Quality
Quality data is the key to successful clinical studies. Encouraging teams to work with integrity and adopt a quality-first mindset, as well as recognising the gap in which they’re filling within the overall jigsaw puzzle, is crucial to achieving success and enabling groups to further build upon it.