All drug development programs are not created equal, and rarely are they the same within a single therapeutic area. A project manager on a drug development team needs to optimize the team network available. He also needs to use gained experience since a program can take many paths.
As I make my initial assessment of a program, I ponder Robert Frost’s poem, The Road Not Taken. The poem begins “Two roads diverged in a yellow wood, and sorry I could not travel both.”
The path’s divergence is a decision point or crisis that needed resolution. Drug development is never standard, and broad experience is difficult to come by. As a result, project managers are often forced to take the less traveled path when developing a clinical program. This is because of the many unknowns that exist until the definition of the program and approval for execution.
Many times a team has to take the road less traveled (scenario planning). This aids in understanding all the implications of the early development decisions. What separates stellar project managers from the rest in the industry? Thinking out of the box and proactive creativity in aligning the development with the marketing strategy.
Managing Complex Clinical Trials
Managing timelines, scope, and cost are usually not enough to understand the intricacies of a complex clinical trial. The PM needs to be the eyes that let the team see the individual trees, instead of the whole forest, or vice versa. The hard work begins with the proposition of a clinical trial.
There are four critical functions that need to come together quickly:
- the clinical scientist
- the trial operations manager
- the CMC scientist
- the statistician
As the collaborations begin, the clinical scientist outlines the endpoints that need completion. These include dose efficacy, safety fold margins, dosing paradigm, etc. The statistician works with the team to understand the make-up of the study arms to power the studies for success.
Understanding probability and variability of meeting the endpoint is critical in designing a study for achieving proof of concept. If the test sample of a few subjects is too small, the possibility of error is very real. This can lead the team to believe the project is going to fail. Achieving results of false negative or positive PK/PD guides the team incorrectly. The statistician will outline the smallest number of subjects to ensure enough data can be collected and evaluated with high probability of success for achieving proof of concept, or maybe a decision for early discontinuation. This saves money and resources for other projects.
With the presentation of statistics, the team knows the requirements for the number of study arms and subjects. They can now begin to identify the number of countries, sites, and subject/patient enrollment ratios.
The team works with the PM to outline the timeline based on the true time and scope of the project. The PM can now use these numbers to outline a few different development plans using various enrollment figures and subject numbers.
The PM works to align the data with related risks. It is important to remember, that cost is usually associated with cost/patient and clinical drug supply, and therefore presented for a governance decision. Aligning team strategy, scenario planning, and controlling risks is valuable, resulting in better management of time, scope, and cost of a program.
“Two roads diverged in a wood, and I took the one less traveled by, and that has made all the difference.” If you read into the poem, the fork in the road is a decision point that needs addressing. Therefore, getting caught up in analysis paralysis will only cause delays for the program.