Facing TMF Bias: My Role is Not Entry Level PART THREE

Part Three: We begin with the end in mind.

I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. This need not be the reality. There is no revolving door where I work. My team has left their TMF bias behind. Where I work, a TMF analyst is not considered a filing clerk or administrative assistant. It is not a “step down” to leave a CRA or project specialist role to pursue management of the TMF.

Most importantly, my team knows my job is not entry level. As an experienced TMF professional, I draw on knowledge gained from hundreds of TMFs to bring a new level of expertise and quality to each clinical trial I am assigned. In this blog series, I’ve examined what key attributes seasoned TMF professionals employ to have the greatest impact on their team and organization. In this, the final post, I’ll discuss the most powerful distinguishing characteristic of an experienced TMF professionals: the perspective to proactively shape the narrative within the TMF.

We understand the drug development lifecycle.

Those of us who are passionate about the TMF are generally attracted to its complexity. Each TMF tells the story of an epic battle between brave patients and disease. Despite the immensity of each TMF, however, a TMF and the clinical trial data it supports might only be a small part of a regulatory submission. For this reason, the most talented TMF professionals know how to take a step back and appreciate how one clinical trial fits in the larger world of the drug development lifecycle.

Understanding the challenges and successes a certain investigational drug may have experienced (even before the first clinical trial) can give great insight into a specific trial’s purpose. This context greatly informs how the TMF should be structured and managed in response. Out of hundreds or thousands of therapeutic candidates, one promising contender has been given the chance to shine. An experienced TMF professional ensures every clinical program lives up to a new drug’s potential.

We begin with the end in mind.

Anyone who has worked as part of a clinical trial has experienced a TMF that feels convoluted, opaque, and aimless. Remediating a TMF that possesses these qualities can be a challenge, mostly because the information within isn’t structured in a way that is accessible. While a host of factors endanger TMF health, perhaps the most common factor is the failure of TMF stakeholders to identify and mitigate the aspects of a clinical trial that will not conform to existing processes. The result of this failure is TMF stakeholders who are confused from the start and are therefore prone to making systematic errors.

Standardization, such as the TMF reference model, can ensure every document has a clear place and purpose in the TMF. Standardization boosts efficiency, reduces errors, and allows for the allocation of TMF expertise across teams and organizations. Standardization, however, must be deployed wisely and with full understanding of a trial’s objectives. An experienced TMF specialist knows how to achieve balance between standardization and customization. A TMF specialist can skillfully adapt tools like the TMF reference model to anticipate study-specific needs while working within real-world constraints. All of this means that a trial’s TMF begins with a clear direction and ends having achieved success.

I hope that showcasing the flexibility, tenacity, and informed perspective of an experienced TMF professional inspires you to reimagine the potential of the people that come together to create the TMF. Simply put, it’s time to reconsider our outmoded concepts of TMF work and look to the future. When I think of all ways the astounding and unexpected ways TMF change has improved clinical operations in the past decade, I can’t help but be excited for the next decade. We’ve already accomplished so much weighed down by TMF bias. Imagine what we can accomplish without it.