Stardate 2004 (by Joe Anderson)

The Star Trek TV series promised to boldly take us “where no man has gone before.” And did it ever. Its three-year run on television exploded into a string of syndications, blockbuster movies, sequel series, and a fanatical cult following. The show did indeed introduce its viewers to a new universe that enthralled and fascinated.

Over the last five years, the pharma industry has adopted numerous technologies to take CRAs where they have never gone before. The modest steps in this direction from the early ’90s have now developed into a plethora of software and processes that impact the monitoring task. CRAs at many companies now find themselves using multiple electronic tools, both in the office and on the road. Let’s examine how to both cope and prosper in this environment.

“It’s Logical”

Among the Star Trek cast, Spock continually exasperated the emotional Dr. McCoy with the inevitability of his cool logic. McCoy’s frequent refusal to accept the facts as they were was countered by Spock’s acknowledgement of and measured response to the current situation. A similar response is now required of the clinical research professional. The accepted prognosis for our industry foresees the continued penetration of computers and software into virtually every aspect of the clinical trial process. This movement has an inevitability to it, that all CRAs must acknowledge and prepare for.

Even if your particular company is currently a “lagging” adopter of such trends, the advantages and efficiencies to be gained through such well-implemented tools are clear. It is only a matter of time until your turn comes – the trend is moving in one direction only, irrevocably forward. Even when software tools are of suboptimal quality or not well implemented, and monitor users suffer because of it, the consistent response from the monitors themselves is “fix it,” not “take back the computer.” Why? Because in today’s working world, including clinical research, it’s logical.

Recognizing the Future

A first step in preparing is to learn the nomenclature of the technologies and to understand where they intersect with the monitoring task. Everyone reading this journal should recognize these acronyms: CDMS, CTMS, EDC, EPD, AES, CATD, eSub. If not, you have a lot of learning to catch up on. It is by no means acceptable in 2004 for you to think this is the province of clinical data management or your IT department and that you already have too much to learn.

Today’s CRA should be familiar with each of these terms and where that tool fits in the overall clinical development process. Most of these categories have two or three leading products on the market in terms of market share. Their advertisements can be found in the industry literature and most of these vendors exhibit at industry meetings. A small investment in time will make you familiar and conversant in what is out there, how it is used and where it is going.

Preparing by Learning the Basics

Numerous conversations with experienced CRAs and technical support personnel suggest that the best adopters of technology within the monitoring profession have grounded themselves in at least three areas of basic computer knowledge. (This is in addition to the tool-specific training that every CRA should expect and receive.) Mastery of these three will prepare you for maximizing the benefit derived from the new tools.

1. Yes, we do Windows. In one Star Trek movie, Scotty travels back to the 20th century and encounters a “personal computer.” Needing information, he announces his request and waits impatiently for the computer to answer. Prompted by his 20th-century host to “use the mouse,” Scotty picks it up like a microphone and repeats the request. Changing tactics, his host suggests using the other input device, to which Scotty exclaims, “Ah look! A keyboard. How quaint!”

Given the ubiquitous presence of computers in our lives, companies can and are expecting monitors to understand the basic components of their computers. Technical support should be and is usually available, but those good folks will ask you “to open the Control Panel” or “plug the cable into the USB port.” Your ability to understand this response, and even the ability solve simple problems yourself by understanding computer basics, will save you innumerable hours and much frustration in the future.

2. Beam me up. With Internet access entering our homes, offices, airports, bookstores and coffee shops(!), being online is an enabling technology that is changing almost every part of our lives. This is not lost on technology vendors, who are busy offering access to almost any clinical data from almost every location. While the advantages to this are clear and the challenges (security, e.g.) are being worked out, the CRA is being asked to connect, to connect and to connect again, both to clinical data and to study metadata, from a variety of locations.

Understanding the rudiments of telecommunications (like knowing the difference between your modem and your IP address, or your Cat-5 cable from your proxy server) will rescue your precious time at the site or your evening of work in the hotel when the connection “doesn’t work like it is supposed to.” Access to data online is great, but not if you haven’t learned how to get to it.

3. I know Google. A common feature of clinical tools is the ability to ask questions of the data they contain. “How many out of range visit dates are there?”, “How many eCRFs have I gotten since Monday?” and “Are there any male Caucasians without a rash?” are ways of resolving, cleaning, and completing clinical information. Any CRA that can create simple queries directly, without asking the Data Management group for a report and then waiting days to get it, will see a dramatic leap in personal productivity.

The good news is that you are already doing this. Anyone who has searched for “FDA and GCP” on Google or clicked the “In the Last 30 Days” button while searching the CNN site is already creating queries to complete information. Using the Advanced Search options on these sites is even better. Your Data Management colleagues may call it “SQL” or “Boolean logic,” but the goal is the same: to learn the basic ways of combining elements in searches to find the desired results. It’s not just for the techie anymore.

Consider How You Work

New Yorkers were treated to a rare sight in the fall of 2003 when they looked out at the East River and saw a supersonic Concorde moving upstream at 5 MPH. On its way to a local museum for display, the Concorde made little use of its overwhelming power and speed to get there and took several hours to make the journey from JFK airport.

We often encounter similar states of technology utilization as we work throughout the industry. It is still possible to find laptops out in the field, brimming with clinical data, query tools, direct E-mail contact with sites and other technology enablers, while, at the same time, the monitor herself continues to follow a process that has not changed in many years. Data is still not reviewed until the next site visit, items are hand-copied between the EDC tool and the monitoring reports (which are still written in Microsoft Word) and study enrollment is hidden in the monitor’s personal spreadsheet on the laptop’s “E:” drive.

Technology implementations require a rethinking of how people work. CRAs can and should serve as an invaluable resource in doing such rethinking with respect to clinical tools. But often, they are the last to be asked and, when asked, they say they have never thought about it and probably don’t have time to. No company can derive ultimate payback from its investment in clinical technology until these end users and domain experts have been invited (and required) to describe what difference the tool can really make.

Stardates: Bridging the Present and Future of Clinical Research

The original Star Trek series was placed in the 23rd century. But Trekkies know that the series itself dated its own episodes in terms of “Stardates.” Such things are necessary, of course, when the universe of the possible has expanded, and it no longer works to see things only in terms of the Sun (or paper). Most Star Trek characters, however, could still work in both modes, as evidenced by the numerous episodes that traveled back to the 20th century. The ability to continue to work with paper-based trials, while preparing for, coping with, and anticipating the electronic future is a skill set that every CRA must cultivate today. Doing so will produce an experience and a career for the CRA that truly is (as Spock always said), “Fascinating.”