Those who do not know history are doomed to repeat it.

Dogs do it. Frogs do it. Logs do it. (At least as long as they are part of the tree.) Companies do it. Even ones like GM, even if they have to be forced. Moving forward, I mean. Evolving. Keeping things that work and discarding things that don’t. Why don’t we?

Our industry has been running clinical trials the same way for some for 20 years. Or more. Most trials still use paper case report forms (CRFs), and most of us still believe that paper CRFs mean months of lag time in receiving, entering and cleaning the data.

I had a client who didn’t think she needed monitoring guidelines. Another who thought that each therapy area should create its own adverse event CRF. I’ve been to countless presentations at countless conferences that talk about the same topics and the same processes and the same “breakthroughs” that I heard 15 years ago. Or even 25 years ago.

Wheels, Reinvented

Now, don’t get me wrong. These processes and breakthroughs were new to those who presented them. The presenters had a problem, they invented a solution, and then presented it. Therein lies the issue. They invented that solution! Even though someone else had solved the same problem 15 years earlier. Or maybe 50, if we were humble enough to investigate solutions from other industries. So what gives? Why don’t we evolve?

Perhaps it’s because many organizations believe their processes are part of their competitive edge. If they share them at all at conferences, it’s usually in such a sanitized, vague manner as to be useless to anyone else. Mind you, the fact that the industry submits fewer new drug applications, and each costs substantially more than the last, does suggest that the industry's present practices are not monumentally valuable.

Another culprit could be the constant mergers and acquisitions that typically result in the acquired firm's innovations being lost when the acquirer's processes are implemented. Then there are the new companies that are understaffed, with people who lack the broad expertise to develop efficient processes and who are often racing to get a drug approved. Venture capitalists won’t wait forever for a return on their investment.

Real Science

To be fair, processes do genuinely progress in a few clinical trial disciplines. Project management, medical writing, and a few other areas. But the bulk of them—site selection, monitoring, data quality, CRF design, and most other operational functions—just don’t. So what is the difference?

The selected “progressors” have (and continue to update) a public body of knowledge. That knowledge can be referenced and improved. Take project management. There are books on project management. There are “theories du jour” and debates about the best approach, and data to support the debates.

This knowledge is available to anyone who cares to search the web, buy books, subscribe to journals, attend courses or get a certificate. It is continually improved by both professionals (who have the practical side) and academics (who spend time thinking about the theoretical and structural side). Most clinical trials disciplines do not have this body of knowledge, or if they do, it’s hidden behind membership organizations or corporate firewalls, isn’t indexed, and is effectively unavailable. It might as well not exist.

A Black Hole

I have attended dozens of conferences over the last 25 years. Many hundreds more have happened that I did not attend. Over that span, thousands of speakers talked about their issues. They have explored theories and developed solutions.

Where are these presentations, these nuggets of knowledge, these insights into the inner functions (and dysfunctions) of our industry? They are mostly gone. Disappeared. Finito. Never to be heard from again. Even when the conference has the occasional high-impact, highly practical presentation, it's not something that can be accessed or read again. No one can build on them to make incremental improvements. Can you really say that you have ever gone back to look at any of the materials from past conferences? Most of the expertise from conferences, it seems to me, evaporates.

Some are forgettable, and for good reason. Some describe solutions that are no longer relevant. But some would be helpful, and we’ll never know. There is a massive body of knowledge that only exists in forgotten files and people’s heads, especially for presentations that were written before the internet. In many ways, allowing this knowledge to vanish represents a departure from the most fundamental principle of science: sharing methods with colleagues. An industry that fails to adhere to that sacred standard is compromising itself.

Let's Do Better

There are additional factors at play. A few publications, such as the Drug Information Association Journal, contain snippets of this material. But they are seldom publicly indexed or generally available, and unlikely to publish process-oriented papers. Most people involved in process development do not see themselves as authors. When they do step forward, their employers often raise legal hurdles to publishing such knowledge. Rather than the approach of academia, where “publish or perish” is the norm, our industry maintains a "thou shalt not publish" mantra instead, at least with respect to process.

In short, our industry urgently needs to document, publish and share process-related knowledge that is detailed enough to be useful in other organizations. The industry should avoid reinventing the process wheel. Every day spent redeveloping a process from scratch, after all, is a day not spent getting therapies to patients. Our industry has a moral responsibility to get products to market as quickly and efficiently as possible. If that means sharing noncompetitive processes and competing largely on the merits of a treatment instead of speed to market and advertising gimmicks, so be it.

Kit Howard is a consultant specializing in clinical data standards (including CDISC), data quality, and process change. She's based in Ann Arbor, Michigan.