“Progressive improvement beats delayed perfection”. – Mark Twain

Churning and Aligning Instead of Doing: Operational Inefficiency in Clinical Development

Steve Shevel, Senior Associate at Waife & Associates, Inc. writes…

Just the other day I was talking with an old friend and the conversation came around to the question of why people involved in clinical development are so busy all of the time?   We went back and forth on some of the usual theories, such as, too many meetings, too many conflicting initiatives and working within the confines of a regulated environment.  But, after much discussion and debate, my friend proposed a very simple but insightful theory which consisted of two principal observations of corporate life:

• We are different people.
• We almost never do anything alone.

This may be self-evident, but the implications are often overlooked and undervalued in addressing the inefficiencies and churn encountered in moving along the clinical development timeline.

My friend gave me a very salient example to illustrate his point:  His company has been discussing the use, and implementation of, Real Word Data (RWD).  After numerous phone calls and meetings, aligning everyone simply on the definitionof Real World Data was still elusive.  We discussed many possible reasons for this churn (and delay in forward progress).  I wondered whether our analytical natures (so integral to drug development), combined with our egos, intellect, need for affirmation, and etc., actually impede operational efficiency and progress.  We rely on these very same qualities to spur innovation, and yet they may be the culprits that prevent us from effectively executingon that innovation.

When reflecting back on my time working in the corporate world and my time consulting to it, it becomes apparent to me that what takes up the most time in any initiative is not the “physicalscience” (the action itself) but rather the “socialscience” (the act of engaging your colleagues and peers in deciding what action to take).

For example:

• Consensus, or at least a mutual agreement on how to proceed, is a paramount value in biopharma organizations.
• Interactions with our colleagues and peers are often influenced more by allegiances and biases then by what is best for our company.
• The circuitous trap that there may be multiple answers to any given question and wanting to explore all available options before deciding on the “best” one.

Clinical Development is complex and the companies that work within this field are filled with intelligent, passionate and innovative people, all with their own ideas, opinions and agendas.  But we should ask ourselves if we are making the operational aspects of clinical development so complex for the right and necessary reasons?

Drug development is, by nature, a slow process and that protracted timeline has contributed to our lack of urgency and our willingness to tolerate delay since the negative feedback for that delay is not immediate. Some may suggest that because we are impacting the health and lives of people, this level of caution and re-thinking is warranted. This is a valid argument for the science, but maybe not so much for the operational aspects of how we execute on the science.   The reason why managers’ calendars are so crowded is because they are spending most of their time talking to, convincing, and aligning people on how to move initiatives forward.

Interpersonal inefficiencies are not something AI or any new information technology will completely solve, as those innovations are more likely to disrupt only the transactional tasks as opposed to the social paradigms, while creating new, as yet unknown, consequences. And yet industry attention is always attracted to the impersonal (and therefore easier to contemplate) promise of technical progress.

We continue to lag behind the pace of physical science with concomitant innovation in the social science of our workplace and processes. We will need both to truly innovate and improve drug development.