How to identify and manage risks in clinical trial supplies
Running a successful clinical trial relies heavily on the management of risks within the supply chain. Risk management is an essential part of clinical trials to ensure you can generate a clear return on investment without disruptions. It’s a complex process of identification and management depending on a number of factors that can impact the effectiveness of the trial. There is no one size fits all approach. Each clinical trial has its own complexities based on the comparator, data, stock shortages which can delay timelines and increase costs. Mistakes can prove very expensive and more importantly, put patient safety at risk.
Successful clinical trials need effective supply chain management procedures to make sure risks are identified and managed in a timely manner so the required medication is available at the site when needed. Taking a holistic approach to assessing and managing risks makes sure you can prevent things that will impact the trial and the data generated. There needs to be a robust methodology in place for identifying, evaluating, and proactively managing the risks involved in clinical trials.
So, what are the risks involved in clinical trial supplies and how can you manage these risks to ensure a successful clinical trial?
Looking at the different phases of the study and the complexities each one encompasses is a great way to identify where risks may arise.
Phase 1 is characterised by a small group of subjects, short-duration and limited distribution. Within this phase, the amount of investigational medicinal product (IMP) can vary depending on the dosing scheme, with a possible increase of up to two or three times more than the original by adding just another subject for example. The product shelf life is still up for review and data will confirm this as it becomes available throughout the study. Costs and duration tend to be lower in this phase than the others due to limited scope and therefore limited resources are required to manage clinical supplies.
Phase 2 is made up of hundreds of subjects and studies can last over months or years. The study can expand into a number of regions and sites which introduces treatment arms that bring with them their own challenges. In this phase, an Interactive Response Technologies (IRT) platform is used to look after randomising and dispensing. Packaging campaigns are also needed to account for country-specific labels in the local language. At a trial in this phase, risk management must be prioritised to ensure costs and timelines are aligned.
Phase 3 involves hundreds and even thousands of subjects with a study duration lasting up to four years. Trials are held at clinical sites across the world spanning multiple regions and countries. The phase 2 challenges still stand in phase 3 but are exaggerated because of the scale of the study. With global studies, differences in how the trials are conducted and managed require more thought. Particularly into the required documentation that differs from countries and continents. At CSI, we run studies with 35+ different medications in many countries. To ensure successful delivery, we spend significant time planning and evaluating supplies.
The risk management process can be carried out in six clear steps from identification to reporting. While there may be some additional actions taken within the process such as time and resources, the benefit of having detailed risk management ensures your costs and data can be protected.
Knowing which risks to identify before conducting clinical trials is the first step in risk management. Specific characteristics of the trial design and drugs can lead to different risks that make the process complex. This requires critical thinking from team members to understand where risks can occur, the severity of the risks and the controls involved. Specific comparators are studied in terms of availability, shelf life, handling conditions, distribution requirements and paperwork.
The risks should be evaluated to ensure they’re prioritised effectively. Look at how likely the risk is to occur in this specific trial and what level of risk it poses to the success of the trial. The risks that are likely to occur and would have a moderate or high impact on trial success should be acted on first and foremost. Using a risk impact matrix is a useful tool to achieve this. Place the risks on a likelihood scale from rare to almost certain, with consequences ranging from insignificant to catastrophic. You could categorise them as low, medium or high risk to decide which risks must be controlled as a matter of priority. At CSI we always develop contingency plans and critically evaluate comparator sourcing related risks.
Putting control procedures in place will ensure the trial risks don’t turn into issues. Risks must be controlled to prevent them from occurring and having consequences on the trial itself. How you decide to control the risks involved depends on the design of the trial and the drugs used. Think about if you will be using an IRT, if the study is blinded, what resupplies will be needed, is there enough internal resource available at each trial stage? These are the types of questions that should be addressed to put actions into place at the right stages of the trial.
An aligned team is essential to ensure trial risks can be identified, monitored and managed effectively. Communicating internally will make sure everyone understands the elements of the trial, the risks involved and the controls that are in place to prevent them. Communicating externally is essential too; sponsors, vendors and stakeholders must have the relevant risk information to track the progress and conduct of the study. We appreciate that nobody likes surprises that can impact study timelines. When medicines are unavailable, we scan the entire global market to provide timely solutions.
The risk management plan should be updated in line with the trial to track changes to the known risks and if any new risks arise during conduct. Look closely at whether the control measures put in place are working effectively and if the risks that had a high likelihood of occurring are being prevented. If they’re not, what else can be done to make sure they don’t occur? This requires resources on hand to document the mitigation’s during the conduct of the trial to make sure critical thinking isn’t overlooked.
The final stage is reporting on the trial and its process. What were the objectives of the study, what was the design of the trial, who was involved internally and externally? Based on these factors, what were the risks that had a likelihood of occurring and what was the consequence of the trial if they happened? If the risks weren’t mitigated by the control measures and the issues occurred, what impact did it have on the trial and data validity?
The key to effective risk management is being proactive. Using critical thinking to identify risks involved in clinical trial supplies and evaluating the impact they could have on the trial if not controlled. Managing risks ensures they don’t become expensive problems and that high quality, valid data can be gathered throughout the trial. Reviewing and reporting on the conduct of the trial and the risk management process ensures you’re best positioned to achieve your trial outcomes.
Contact CSI to discuss how we can deliver a detailed, zero-tolerance risk management approach for your clinical trial supplies.
The advantages of biosimilars vs branded products in clinical trials
The growth in the biosimilar market since 2006 has been significant.