Is That an Edsel or a Porsche that Just Pulled Up?

Does everyone remember the Edsel, the big-nosed, problem-plagued Ford named after the company chairman’s son? While we would never mistake such a car for the latest Porsche 911, many of us live in fear that we cannot tell which best represents the clinical information technology that just pulled into our driveway for a test drive. This is more than an amusing metaphor: it stands between us and the future of more efficient clinical trials. The choice is not so simple when shouldering the responsibility of processing the data upon which your company’s future may rest.

What’s the Problem?

Technology innovation is proceeding at least twice as fast as the clinical research industry is adopting it. Is that a problem? For the vendors, yes. For the sponsor who wants to be innovative, possibly. For the industry as a whole, not necessarily. Innovative sponsors must understand that the technology they saw at the wireless Internet tradeshow yesterday is not available as a clinical research product today. Cautious sponsors must understand that vendors, by their nature, will pursue the latest technological advance. Vendors must understand that the clinical research industry, by its nature, will take its time in changing its ways. Quite a dilemma.

Your old car (paper-based clinical trials) isn’t necessarily a bad car. It gets you where you want to go. When you put enough mechanics on it, you can lock a database in 48 hours. You can “get there” (choosing effective investigators, keeping track of trial progress, storing the program data, preparing submissions) well enough. And if not well enough, well, the pain you know is not worse than the perceived pain of change.

On the other hand, the Porsche sure is pretty out there in the driveway — why not buy it now? Well, for one thing, the technology seems to change weekly; the best solution may be just around the corner. And anyway, there are too many vendors, too many choices, all nearly the same. Plus, you don’t have the resources to evaluate what’s out there, understand your internal status quo, or manage the project. If that weren’t bad enough, you don’t have the budget, or even understand how the Porsche should be paid for.

So, fine, why not keep the old car? For several important reasons. You know you can do better. You’ve got much farther to travel, much faster, with more passengers, than the ol’ buggy can handle. Your staff don’t want to drive it anymore (or don’t know how). Your mechanic won’t fix it anymore; the dealer closed. Your competitor bought the Porsche, and then he moved to a better neighborhood.

Why should a clinical research organization adopt leading-edge IT? Because you probably have:

the need for high-throughput capacity

the need to retain your employees

the need to stay competitive.

Besides, the Porsche is a better car. It has many usability and efficiency advantages. It enables you to do things you could never do before. It leads to better, exciting uses of technology, by providing a platform for information integration, and therefore higher usefulness of that information. Great, but we usually feel we cannot afford to be wrong — we can’t risk that Porsche turning into a latter-day Edsel.

Control Over Risk

Sponsors, properly, want control over risk. But they do not have enough resources in IT or clinical operations to handle change management, work process change, project management, IT infrastructure issues, metrics, SOPs, and all the other requirements for successful application implementation. What is the answer? There are several possibilities.

One answer is to “stage” innovation. Think carefully about all the choices in front of you. Which is more important – your CDMS or your Data Warehouse? Which is more important — study startup or data cleaning?

Another answer is to use Metrics, and use them properly. Sponsors too often apply old technology or paper metrics to electronic processes. The result is that metrics targets are set unreasonably, out of context with a baseline (because the baseline is unknown!). Knowing your current performance (through Metrics) is essential to knowing where the innovation is worth the pain of implementation.

Another answer often assumed to be clever is to offload much of the difficulties onto the Vendor. Here you need to be careful: are you creating an unhealthy dependency or a controlled one? This strategy does provide opportunity for flexibility, if properly controlled. This comes back to the issue of internal resources. Perhaps a third-party can help by “being you”, virtually.

Understanding Vendors

The more enlightened and savvy vendors in the clinical IT marketplace understand many of the dilemmas you face, to a certain extent. An answer to control over risk which they have come up with is the “rent” or “lease” business model, which in a way puts them in a role sponsors feel they can recognize — a CRO-like model, where the vendor does everything and “just” delivers the data or information. This may be acceptable to you, but it can also be dangerous: it permits you to avoid real process change, so the real benefits of innovation are not achieved. It also leaves the vendors in a potentially fragile position, where they can be tossed aside at any moment. And yet vendors are very interested in this model. In today’s marketplace, where all vendors need to attract funding from investors, bankers or the public markets, they need to have both growing current income (usually at unrealistic rates), plus recurring revenue of some significance. The rent/lease model is the result.

Does It Matter?

Over the next 5 years, maybe we shouldn’t care so much about the strategic adoption of clinical IT. Perhaps it is sufficient for individual “champions” within sponsors to get their projects to use innovative IT-based processes, and succeed or fail individually, while core functions remain “safe” in (increasingly) old technologies and processes. Once the road is “clear”, you can crystallize operations around the proven path. But will it ever be clear, or do we instead have to learn to be ever-changing?

The pressures on clinical development are likely to overcome this “safe choice”. The pace of clinical IT change is very different from that of drug technology change, or the pace of change in how your company markets its products. You can’t stay isolated even if you wanted to: the lines are blurring between Development and Discovery, and between Development and Marketing, and you in clinical research can’t be pushing paper around in the middle.

What Should We Do?

We need to accept that business life means constantly changing (and investing in) technology. Learn to live with it: create a change management culture in your company. Control risks through knowledge — especially of yourself: your costs, your strengths and weaknesses. Understand that process change is the more important critical success factor — more important than the technology platform or the vendor choice.

So is that an Edsel or a Porsche in the driveway? You can’t wait to find out, because by the time you know for sure, there will already be a better car idling outside. In the end, you have to get out there and drive. Worst case, if it turns out to be an Edsel, it’s still faster than walking. In the best case, you will have created a stimulating, more efficient, more competitive, and more attractive work environment for clinical research in your company.