The drug development process by its scientific nature is one which is closely controlled, informed with rigor and volumes of data. But there is an interesting bifurcation between the research (in vitro) phase and the clinical (in vivo) phase. We can and must carefully control the first stage, but when we move to administering new drugs to humans, we enter the enduring mystery and variability of biology and environment. In human trials we have to let our discovery go off into the world, like a child sent to college on her own. What happens next we cannot control – we can only observe, record and analyze.

Our business lives and dies on the results of these clinical trials we have so little control over. But there are aspect of this stage which we dohave control over: the processes and infrastructure in support of the trials themselves. An yet most companies ignore or are unaware of this opportunity. Yes, everyone is busy running the current trial; yes, we need to get more patients enrolled more quickly; yes, we need to organize the next investigator meeting; and yes, we need to make sure that documents are being collected and data is being cleaned.   But meanwhile we may be missing a very real opportunity to address the one thing that we can control, and that is the process of how we go about executing any one, or all, of those workstreams. 

Clinical trial process optimization is often recognized as a need but rarely prioritized. Executive management is hesitant to assign resource time and budget to these initiatives in the midst of a clinical trial for fear that staff will be distracted and the trial progress will suffer. Additionally, initiatives for optimization are not milestones that can be advertised to Wall Street as progress, and so they end up being assigned to the “nice to have” category on the priority list.  Middle management may have the vision and energy to spearhead these efforts, but without strong executive support their efforts usually fall short, since the task remains subservient to a multitude of other trial-related needs.  Unfortunately, this lack of priority leads to failure, and with each failure comes a negative psychological bias and associated fatigue around operational improvement which directly impacts any future initiative.

The irony, is that assigning meaningful resource and budget to the process of conducting clinical trials and how the organization is structured to support those trials, is something we can in fact controland those efforts will have a direct downstream impact on the tangible, reportable outcomes, such as:

• Collecting and analyzing data more quickly
• Helping improve enrollment
• Increased productivity
• Avoiding duplication of effort
• Effective scalability and consistency
• …and more.

Often our industry uses the excuse that we work in a highly regulated environment and that this is the reason for our lack of innovation in trial operations or how we adopt new technology.  In the past this may have been understandable, but the regulatory agencies have recognized the importance of streamlining the drug/device/biologic development process and are in fact encouraging companies to become more efficient.  In fact, departing FDA Commissioner Scoot Gottlieb made reference to this point which you can read in the following link: (https://www.fiercebiotech.com/biotech/gottlieb-criticizes-sponsors-continued-reluctance-to-rethink-clinical-trials).

Focusing on how we conduct clinical trials will differentiate one organization from another beyond the science, and perhaps provide that oft sought-after competitive advantage.  Whether you are looking to bring the next CAR-T treatment to market, or the newest gene therapy, or the next Alzheimer’s treatment, once the trials have begun there is very little you can do to influence the success or failure of those experiments scientifically. What you caninfluence is all of the supporting factors that facilitate starting, conducting and completing those trials as quickly as possible, and getting and analyzing the data as expeditiously as possible. Trial results – the culmination of the scientific effort – will make the difference in your clinical, corporate and personal success. Obtaining those results with the appropriate quality and speed are the things you can control, and are worth investing in improving.