The Importance of Checklists in Clinical Trials

What can Clinical Trials learn from the Miracle on the Hudson?

If you have watched the 2016 film, "Sully", detailing the events of US Airways Flight 1549, you will probably remember the scene which depicts the moments after the plane struck a flock of Canadian Geese, approximately two mins after take off from LaGuardia Airport in New York City.

In those crucial seconds, one of the first actions of Captain Chesley 'Sully' Sullenberger, was to instruct his first officer, Jeffrey Skiles, to get out the QRH and check for loss of thrust in both engines.

The QRH, Quick Reference Handbook, is an aircraft?technical document?and quick-access?manual?for?aircraft pilots?that contains all the procedures applicable for non-normal and emergency conditions in an easy-to-use format.

For each scenario in the QRH, the pilot is given a list of procedures to execute in a specific order, to try and recover from the relevant situation.

In flight 1549's case, as the scene continues, you will see First Officer Skiles calling out and trying multiple steps in an attempt to restart the engines.

Commercial airline pilots are highly trained and spend hundreds of hours in simulators, so this raises the question why do they need to go to a checklist in the case of an emergency?

Surely they should be able to rely on their training and expertise? Why do they have to start reading what to do, right when things are going most wrong!

There are clear and simple reasons for this approach and the use of the QRH.

We can learn from this and how it applies to our own work arena.

Checklists are prepared when things are calm

The time when a checklist is needed is not the time to be writing one.

The focus instead should be on following a well defined process, in a steady manner, rather than trying to think of the required steps when you are under pressure or completing a critical task.

Preparing in advance, allows plenty of time to correctly map out all known scenarios.

Eliminating pressure and chaos from the situation, means that each step can be logically examined, tested, revisited and revised.

It also allows a range of people to be involved in the development and review process.

This ensures the maximum amount of expertise and knowledge can feed into the final product.

Checklists support knowledge, but don't replace it

Sometimes we are reluctant to codify tasks and processes into checklists because we fear people will become reliant on them and the connected knowledge and skills will be lost.

However, thinking back to our example of airline pilots, the fact the QRH exists, doesn't mean they can or should be any less well trained or qualified to be flying the plane.

Pilots still have to understand how to fly the plane safely in all conditions. They must know what all the functions of the aircraft are, what all the buttons do and what the screens and dials are telling them.

The function of the checklist is to ensure that, when under extreme pressure, they don't have to think about what to check and when, but instead can focus on executing the steps in a rapid, controlled fashion.

Checklists grow as we learn

As external processes, roles and technologies change, there will be impact to some degree on the tasks we need to perform. They may become more simple or complex.

Regular reviews of checklists, mean that they can be adapted, updated and re-tested to match the latest available information.

As well as developing the content, the users can also feedback on areas that need to be improved for clarity or ease of understanding.

Specific Use Cases of Checklists in Clinical Trials:

• Protocol Compliance: Ensure adherence to study protocols, reducing the risk of data integrity issues.
• Site Initiation and Activation: Streamline the process, minimizing delays and ensuring compliance with regulatory requirements.
• Patient Enrollment and Management: Standardize procedures for patient screening, consent, and follow-up visits.
• Data Management and Analysis: Ensure data accuracy, consistency, and completeness throughout the trial.
• Regulatory Submissions: Guide the preparation of regulatory documents, such as clinical study reports and submissions to regulatory agencies.

Benefits of Checklists in Clinical Trials:

• Improved Efficiency: Streamline processes, reduce errors, and minimize delays.
• Enhanced Data Quality: Ensure data accuracy and consistency, leading to more reliable study results.
• Reduced Risk of Regulatory Non-Compliance: Help organizations adhere to regulatory requirements and avoid penalties.
• Increased Patient Safety: Minimize errors and inconsistencies that could impact patient safety.
• Improved Team Collaboration: Foster a more standardized and coordinated approach among team members.

Challenges and Considerations:

• Resistance to Change: Address potential resistance from team members who may be hesitant to adopt checklists.
• Tailoring Checklists: Ensure checklists are tailored to specific study requirements and are regularly updated as needed.
• Avoiding Overreliance: Emphasize the importance of using checklists as a tool to support, rather than replace, human judgment and expertise.

So, next time you have to complete a complex set of tasks, or deal with a demanding situation, take some time afterward to see if you can write a checklist of all the key steps and watch items.

Record the critical elements or the pieces of the process you found to be more challenging. Remember to include any lessons learned, or specific notes or points of self-advice.

This will put you in a great place to succeed on your next run round!

Thanks for reading