Every decision makes sense on its own, and the whole still goes nowhere. That's what happens when we stop navigating by what we're actually here to do.
You have probably seen at least one of these this year.
- The company process for audit trail review, meant to protect data integrity, explodes into an administration and bookkeeping exercise of its own.
- The new CRF standard, agreed after months of workshops, is quietly not complied with. Study by study, for good individual reasons.
- Global IT rolls out a great new technology. Well built, well tested, well communicated. Nobody uses it.
- The recruitment strategy on the pivotal trial changes. Again.
- The outsourcing model that should result in less in-house work results in more: oversight, reconciliation, rework and meetings about meetings.
None of these happen because someone is lazy or incompetent. Each one is a sensible decision made by capable people. That is exactly the problem.
Somewhere along the way we lose track of what we are actually here to achieve, and of the fundamental principles for how we do it. We lose track of what executing clinical development is all about.
Complexity is the enemy of execution
Clinical development is complex. Protocols, regulations, vendors, systems, countries, sites, patients, timelines, budgets. Complexity is the enemy of execution: it makes the work hard to do, and it makes it hard to deliver what we are here to deliver.
So simplifying is good. Breaking a big problem into smaller pieces, giving each function a clear scope, letting a team own its part, that is how complex things get done.
But there is a difference between simplifying and isolating. When we simplify by cutting a piece loose from its context, from the programme, the patient, the overall direction, we don't remove complexity. We just move it somewhere we can't see it.
Small decisions, net negative
Isolated simplification produces small, isolated decisions. Each one is the easy way out locally. Each one is defensible in its own meeting. Add them up and the net effect is negative. Sometimes we don't reach the goal at all. We go in circles, and we don't see the forest, or the way out of it, for all the trees.
Think of a compass. Hold it next to a piece of iron and it still points confidently, just in the wrong direction. Every function, trial and initiative carries its own piece of iron: its KPI, its budget line, its timeline, its agenda. Close enough, it pulls the needle.
And the needle never looks wrong. That is what makes it dangerous.
The symptoms are easy to recognize:
- A list of urgent fixes rather than a coherent plan.
- Pivoting, and pivoting back.
- Priorities that change faster than the work can be finished.
- Changes that get implemented, but whose benefits are never realized.
What we need to do
Not more initiatives. Fewer, connected ones. The answer is not to stop simplifying, it is to simplify with the whole in view. And the whole has a centre.
We do clinical trials. That is the job: generating the evidence that brings treatment to the people who need it, and yes, doing it profitably. Everything else is an enabler. IT, procurement, process management, quality assurance, standards, AI, necessary and valuable, but enablers. We don't do any of them for the sake of it. Every process, standard and tool has to answer one question: how does this help us run better trials?
But the trial is not the whole either. A trial run in isolation is just another piece of iron next to the compass.
Take the CRF standard. A study team deviates, for good individual reasons. A different visit structure, a customized form, a faster build. Defensible in that meeting. But a trial is rarely the end product. Its data will be pooled with other trials for the integrated safety and efficacy analyses in the submission. Every deviation becomes a mapping exercise later, or, at worst, data that cannot be pooled at all. The work and the risk didn't disappear. They moved downstream: to data management, statistical programming, the submission team and the next trial that inherits the setup.
Good individual reasons are not good enough.
Every trial-level decision has to be weighed against the programme around it: what does this mean for the other trials, for pooling and submission, and for everyone downstream? The same goes for the recruitment strategy on the pivotal trial, the outsourcing model and the audit trail process. That takes two things: people who keep checking the compass, and an organization built so the compass stays readable.
What you can do
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Go back to the fundamentals.
Why do we review audit trails? Why a CRF standard? Why that oversight model? We don't do things for the sake of it, we do them to achieve something. If you can't explain the why, find out. -
Step back, in small and large.
Before the next decision, look at it holistically: what are we actually trying to achieve, and does this get us closer? Look one step up, to the programme, and one step downstream, to whoever inherits your decision. -
Raise your hand.
Hopefully your company culture welcomes it. If it doesn't, you still have a responsibility; find a way. -
Leave ego behind.
The right answer may not be your preference, your function's preference or your idea. It is still the right answer. -
Ask for help.
Seeking input and support is not a weakness, it is how you see beyond your own piece.
What companies can do
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Put leaders in leadership roles.
Leadership and management is a discipline of its own: structure, planning, leading people, creating coherence and a common direction. It needs SMEs in leadership and management, not SMEs in SME-ing, and not SMEs in climbing the ladder. -
Own the operating model.
Build strong, common structures for managing processes, standards and technology, how we do things, and why. This is not a side hustle, and it cannot be run in isolation: not in core functions, not in support functions, not in individual projects or trials. It takes serious management and serious effort. -
Remember what business you are in.
Clinical trials, bringing treatment to people who need it, profitably. Steer and measure every enabling function by how well it serves the trials, and every trial by how well it serves the programme. -
Make the why count.
Embed the how and the why in company objectives, personal objectives and appraisals, and hold on to them. Don't let the portfolio trump them every time.
Bottom line
Clinical development will never be simple. But it can be coherent. We do clinical trials, and no trial stands alone.
The compass is still there, we just need to step away from the iron and look at it again. Together.
The views expressed are the author's own and should not be read as an interpretation of regulatory guidance.
