Updated: Feb 17
This is the first in a series of blogs devoted to practical Risk Management tools. Practical exercises you can quickly and easily lift, adapt and use in your organization.
Clinical trials are based on assumptions. It’s inherent in the process because teams have to plan without complete or perfect information. Teams therefore make assumptions about a whole range of things including tasks, activities, patients, sites, partners, and risks.
But making assumptions can be dangerous. If the assumptions are based on faulty information, or just completely wrong, the trial will inevitably fail. If the person or team making the assumptions have biases, or are under pressure from external parties, they can make assumptions based on what they’d like to see happen rather than what they expect to see.
And the longer assumptions go unchecked the greater the danger that they can become accepted as ‘fact’. Testing assumptions right at the start adds rigour and significantly improves the planning process.
The objective for this exercise is to identify and test all assumptions created and used in the planning process.
In relation to RBQM, we’re referring to the assumptions made when identifying critical processes and data (ICH E6(R2) Quality Management 5.01) and identifying risks (5.02). This includes identifying assumptions that have been made ‘unintentionally’ (“that’s what we’ve always done”), and assumptions made about other data sources such as previous clinical trials (ICH E8(R1)).
Each assumption will be tested for its validity. If an assumption is found to be invalid or irrelevant it will be discarded, and the plan adjusted accordingly.
Setting up the exercise for success
For this exercise to be successful, it should be free from bias. That means picking a neutral facilitator, ideally, one familiar with the clinical trial process, but with no specific involvement with the planned trial. Even better if they are from outside the company. You’ll need to include a wide range of people from all areas touching on the clinical trial to ensure that no gaps or areas are overlooked.
This is not a quick exercise because you need to ensure everyone has had their say. Schedule a whole day for the exercise. If it takes less time then great, people can have some of their day back to do other things, but if you rush it, you run the risk of missing something important.
A week before the meeting send all the participants the plan and a list of all the assumptions so they can familiarize themselves with the content and come prepared to ask questions. It can be helpful to group the assumptions into categories or business areas, but there should be a reference back to the plan so people can quickly and easily move to the right page in the plan.
Running the exercise
Depending on how many people are in the meeting, you may need to split them into groups. Seven is ideal, but no more than 10 to ensure everyone has time to talk. If you are going to be working in groups, the facilitator needs to ensure that no individual or area dominates a group discussion and over-rules any questioning or challenge.
Start the meeting by ensuring everyone knows everyone else and their role. We’ve all been in those cringe-worthy meetings where you have to go round the room introducing yourself. But knowing who everyone is, and their potential contribution to the exercise, is important. Good facilitators will know games, tips, and tricks to make this exercise more fun and engaging, but it shouldn’t be missed.
Next should be a short (5 minute?) introduction to the plan by one of the team. It doesn’t need to be a read-through of every line, but it should set the context and the objectives so that everyone is on the same page.
Now it’s time for the hard work. You need to go through each assumption and stress-test it. That means asking pointed questions, like: why is this a valid assumption? What data is it based on? Who made the assumption? Is there any evidence or past experience that it’s valid? Are there a range of possible outcomes rather than just one option? What do we know from the rest of the organization, competitors, partners or regulatory authorities? Are there any biases influencing the assumption? Are there other external factors we need to take into consideration?
The point of asking all those questions is not to assess assumptions as “right” or “wrong”, what you want to know is whether this is a reasonable assumption given all that we know at this point.
If an assumption is found to be invalid or irrelevant then it needs to be discarded or amended, and the plan adjusted accordingly. Ideally, you’d do this in the session while you have the right people in the room, but it may need to be time-capped or taken outside the meeting given the volume of work to get through.
You may use some, all, or none of the questions above, but when you start to consider them, you can see why the exercise can take a lot of time. The facilitator also needs to be very careful about how the questions are phrased and asked. It’s easy for people to feel threatened or beaten (even bullied) by questioners. That is most definitely not the outcome you want.
Running a critical factors assumptions review is not quick, cheap, or easy. But it can save you from making big, expensive, dangerous, and avoidable mistakes. That makes it worth the time an effort and why it should be part of your RBMQ toolkit.
And you’ll get better and faster at it the more you do. If people see and understand that challenge and discussion is part of the process, you’ll be a long way toward the quality culture that supports open dialogue as is being promoted in ICH E8(R1).