Risk identification in clinical trials is a proactive and ongoing process of systematically detecting, documenting, and assessing potential threats that could hinder the progress, integrity, or outcomes of a trial, setting the foundation for subsequent risk management activities.
For clinical trial managers and clinical quality assurance managers, risk management is not just an optional add-on but a critical necessity. It enhances the safety and efficiency of clinical trials, ensuring regulatory compliance and protecting the reputation of the organisation.
In this blog post, we’ll explore five common pitfalls in risk identification and provide insights on how to avoid them. But first let’s understand it in the context of vendor management.
Risk Identification in Vendor Management
When outsourcing to vendors in clinical trials, risk identification is the initial step in developing a robust risk management framework. Given the complex relationships between sponsors and vendors, it’s crucial to pinpoint potential issues that could arise during the trial.
These risks could relate to data integrity, patient safety, compliance with regulatory guidelines, or even reputational hazards. Understanding these potential risks helps inform the development of risk mitigation strategies, improving the overall efficiency and reliability of the clinical trial.
By properly identifying risks, sponsors can ensure a smoother relationship with their vendors, ultimately improving trial outcomes and maintaining high standards of quality and safety.
Pitfall 1: Subjectivity
Subjectivity, is when personal biases shape our understanding of risk severity or likelihood. This issue can lead to significant threats being overlooked or minor risks being exaggerated.
Consider a Clinical Trial Manager (CTM) who has had a great experience with a specific vendor. Their personal bias might understate the real risks of outsourcing to this vendor.
Conversely, a team member with a bad experience with the same vendor might overstate the potential risks. This subjective view can compromise the effectiveness of the risk identification process.
How to Avoid
Utilise structured processes, tools, and techniques to identify risks. This could include systematic interviews, brainstorming sessions, or utilising risk identification software. These methods provide an objective framework that can reduce personal biases and ensure a comprehensive approach to risk identification.
Pitfall 2: Lack of Depth
Lack of depth, is where risk assessments skim the surface without delving into the root causes. This tends to occur when the focus lies solely on apparent risk symptoms, neglecting the underlying issues.
For instance, a Clinical Quality Assurance Manager might notice delays in data submission from a vendor. The immediate reaction might be to identify the risk as “vendor delay.” However, this does not examine the root cause of these delays.
Are the delays due to poor vendor management, lack of training, inadequate tools, or something else? Failing to delve deeper into the issue means the identified risks will be symptoms rather than the root causes.
How to Avoid
Thorough risk identification should involve a deep dive into each potential risk. This will enable the creation of robust mitigation plans that target the root causes and not just the symptoms.
Implement a root cause analysis technique, such as the ‘5 Whys’ technique. This approach forces teams to dive deeper into risk factors and helps uncover underlying issues that might not be apparent at first glance. Addressing these root causes can significantly enhance the effectiveness of your risk mitigation strategies.
Pitfall 3: Misunderstanding of Roles in the Clinical Trial
Misunderstanding roles within the clinical trial process and how they relate to potential risks. Every role, from the principal investigator to the clinical trial manager and sponsor, comes with unique responsibilities and associated risks.
Consider a scenario where a Clinical Trial Manager is focusing solely on their domain and doesn’t consider the risks linked to other roles. For instance, if a data discrepancy arises during the trial, they may attribute it to a data management issue without considering other potential sources of risk, such as protocol non-compliance by investigators.
This siloed approach can lead to incomplete risk identification. It’s crucial to understand that risks in clinical trials are interdependent and cross-functional. Misunderstanding roles and their associated risks could lead to oversight and mismanagement, potentially jeopardising the trial’s success.
How to Avoid
Clear definition and understanding of roles and responsibilities within the clinical trial team and all stakeholders involved in trial delivery. Create a detailed risk identification statement structure that includes all relevant roles and their associated risks. This promotes accountability and helps ensure that all risk factors related to specific roles are identified and addressed.
Pitfall 4: Lack of Structured Process
Lack of a structured process for risk identification. Without a formalised approach, risk identification can become inconsistent, potentially allowing significant risks to slip through the cracks.
Imagine a scenario where the risk identification process is mainly reactive, triggered only when an issue arises during a clinical trial. In this case, the team tends to respond to symptoms of problems rather than anticipate and mitigate the risks proactively. This reactive approach leads to constant firefighting, ultimately affecting the trial’s timelines, costs, and data integrity.
How to Avoid
Develop a structured risk identification process. This should include risk categorisation, focusing on patient impact, data impact, reputational impact, and regulatory impact. A structured process ensures consistency and comprehensiveness in risk identification, allowing your team to anticipate and prepare for all potential risks.
Pitfall 5: Lack of Ongoing Review
Lack of ongoing review in risk identification, in many organisations, unfortunately, view risk identification as a one-time activity at the initiation stage of the clinical trial, a misconception that can lead to unforeseen complications later on.
Think of a scenario where a vendor initially had a strong track record but begins to show signs of quality issues partway through the clinical trial. If the risk identification was conducted only once at the start and never revisited, these emerging issues would not be flagged as potential risks until they have already caused significant disruption.
Risks are dynamic and continually evolving as the clinical trial progresses, with new threats emerging and existing risks changing in severity. Therefore, ongoing review, often referred to as ‘continuous risk assessment,’ is crucial to ensure all potential risks are identified and managed promptly. This includes routinely revisiting and updating the risk identification process, allowing for the timely discovery and management of any new or escalating risks.
How to Avoid
Regularly review and update your risk identification processes. Establish scheduled risk review sessions and use these opportunities to reassess your risk landscape, update your risk register, and adjust your risk mitigation strategies accordingly.
Risk Identification Statement
A Risk Identification Statement should succinctly encapsulate the identified risk, its potential impact, and the context in which it could occur. This statement might follow a structure like this:
In the context of [specific situation], there is a risk that [risk event] could occur, which could result in [consequences], this means that [impact]
E.g.
“In the context of data management by an external vendor, there is a risk that improper handling of sensitive patient data could occur, which could result in a breach of patient confidentiality and potential regulatory non-compliance, leading to delays in the trial and potential regulatory action for Data Protection Breaches”
This structure provides clear, concise information that allows for the appropriate prioritisation and management of the identified risk.
Wrapping up
Avoiding these common pitfalls in risk identification in clinical trials can result in significant benefits. An effective risk identification process can reduce uncertainties, improve patient safety, enhance data quality, protect your reputation, and ensure regulatory compliance.
It’s worth investing in identifying risks early and managing them proactively, ensuring your clinical trial runs smoothly. After all, a clinical trial’s goal is to improve patient health outcomes, and effective risk management is a vital component of achieving this goal.
