As the old joke goes, the way to get to Carnegie Hall is practice, practice, practice. In the clinical research industry, as we constantly struggle to improve work processes widely known for their inefficiency, it is very fashionable to talk about “best practices”: if we can learn how the best pianists play their instrument, and copy them, we can be great pianists too. Entire businesses are built around selling best practices to biopharmaceutical researchers. I object. We are falling for best practices instead of learning more about our own.

The concept of best practices is based on the assumption that in any particular field, many organizations do the same tasks, and make similar mistakes, and can learn from these successes and mistakes with varying degrees of benefit. The assumption goes further, that one can derive the “best” practices by surveying how all organizations that do a similar process perform.

While learning from others is a great idea, too many clinical research executives have fallen in love with the best practices concept without examining it very carefully. There are several flaws in the best practice concept:

– that performance is a constant continuum, and better performance must mean best practice
– that what is best practice for the pianist is best practice for the violinist
– that we can recognize a best practice when we see one.
– There are two further problems:
– a practice is only “best” if it fits with your business strategy, and not all biopharmas have the same operational or commercial strategies
– and most importantly, that being enraptured with best practice takes our eyes off what we should be looking at: how to improve our own practices.

Your Performance is My Rehearsal
Best practices are usually claimed on the basis of some achievement a rapid database lock, a significant cost savings, a reduction in headcount, a speedy drug approval. Such achievements are rightly applauded, but their relevance to your company is nearly non-existent, unless you know how closely the circumstances of that company©ös past performance match those of your upcoming project. And worse yet, a company©ös “best” database lock may not even be better than yours, when the circumstances underlying the performance are examined.

The main problem with best practices as applied in biopharma is the huge variability amongst the organizational, resource and process parameters in each clinical research department. The pseudo-scientific assertions of best practices and benchmarks cannot hold up under the scrutiny we would apply to clinical trials results: are the comparators controlled, are we using common denominators, are we even using the same definitions? The answers are all “no”.

If a company reports that they can lock a database, using traditional paper processes, in a week, is that a best practice, or excellence in working overtime? If a company says they saved millions of dollars using a new technology, but did so only because they were using expensive contractors to do the work, and you don©öt use contractors, will you reap the same savings following this best practice? If a company claims best practice in regulatory approval strategy by achieving simultaneous multi-country registrations, is any of that relevant to your drug, in its particular therapeutic area, at the time it attempts market entry vis-?-vis its competitors? The variables are endless.

This is not to say we don©öt have much to learn from others. The challenge is in obtaining reliable (truthful or accurate) information from others, and then knowing ourselves well enough to recognize if what we are hearing from others is applicable to our situation. Self-ignorance undermines any meaningful learning from best practices, assuming there are such things.

A Better Practice
I propose a different, more useful definition of best practice: “A best practice is a process which enables a group to meet its employer’s properly defined business objective.” In other words, a best practice is not a universal truth. What is best is what fits your business strategy, not someone else©ös, and you can find best practices if you look within your own relatively homogeneous operational circumstances.

Knowing how long it took you to register a first-to-market oncology drug in three prime markets is very relevant to the second time you seek to register a first-to-market oncology drug in three prime markets. If you beat your previous time, and controlled for any other variables, you have achieved a best practice one to measure yourself against the third time you try it. Similarly, if you can review retrospectively and accurately the database lock times on a series of trials whose dozens of parameters (number of data fields and edit checks, process and tools used, hours worked, quality of sites and time to reconcile adverse events, etc., etc.) are nearly identical, you can establish your best practice, and know what target to aim for to beat it.

An Example
Let’s take one simple example. Company A is examining how it organizes and uses its in-house monitoring staff. At an industry conference, Company B claims it has developed a best practice in organizing monitors, based on regionalization plus an expanded in-house documentation staff. Every one on the conference panel applauds and says Company B did a great job. The idea that this is a best practice is endorsed. Consultant X then writes a White Paper based on Company B©ös experience, and the solution is officially canonized. Company A, suitably impressed, moves quickly to adopt the same organizational structure and process.

What can wrong? Lots of things. Company B could have more resources than Company A and therefore afford a more efficient geographic distribution of monitors. Company B could have already established better knowledge of high performing investigators. Company B could have different personnel policies and pay scales that allow the efficient build up of low-cost in-house workers. Company B©ös regulatory SOPs may be more amenable to this particular division of labor. And so on, ad infinitum. This best practice is just a practice; what is “best” is in the heart and head of each of us.

The answer to this situation is for executives to stop coveting their competitors©ö processes and work much harder on understanding their own. Every biopharma already has best practices (and worst practices), waiting to be uncovered, analyzed and learned from.

Truly understanding how your own company works is the first step to the Carnegie Hall of clinical development performance. Refining your own best practice — the way you play the piano, not how your colleague plays it will determine whether your clinical research will deserve a standing ovation.