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Paper-free clinical trials may not ever happen-but many of its advantages are already available.
Paper-free clinical trials may not ever happen-but many of its advantages are already available.
We are nowhere near the nirvana of a completely paperless office. Yet the value of word processing, spreadsheets, and email is simply indisputable. Similarly, the vision of a completely paperless clinical trial from concept to submission is still on the distant horizon. Nevertheless, the industry has begun the steady elimination of paper in the management of clinical data and documents, from patient diaries to eCRFs to fully electronic submissions, and is reaping significant benefits. To understand this, let's look at the paperless office.
Office automation began taking the world by storm back in the days of the electric typewriter, made by IBM. The office progressed rapidly in the adoption of technology from the office copier (invented 1938, first practical commercial version 1959, both by Xerox), the fax machine (invented 1843(!), first practical commercial version 1966 by Xerox), to the dedicated word processing machine (invented in 1964, first practical commercial version 1969, both by IBM). A watershed event was the introduction of the IBM personal computer in 1981 with its "killer application." Many think that this "killer app" was the word processor, but actually it was considered to be the spreadsheet, invented by Dan Bricklin (a wonderful description of this can be found by visiting http://www.bricklin.com/history/saiidea.htm).
In these early days, many predicted the demise of paper in the office. The noted futurist Alvin Toffler said in 1970 that "making paper copies of anything is a primitive use of machines and violates their human spirit." The vision was of a paperless office, where all documents are outlined, created, reviewed, communicated, commented upon, and read online. There would be no reason, so we were told, to ever print paper. This future would be bright, cheerful, and efficient. Nobody would ever have to search for a document, as they would all be available at one's voice command. Viewed more than 30 years later, this vision is almost laughable.
The facts are even more shocking. The use of paper in offices, from the printing of emails and Web pages, is growing at 6-8% per year, with the average employee printing 33 Internet pages per day. Paper usage doubled from 1981 (the introduction of the PC) to 1995, and most people feel swamped with paper in many forms. We still print out our documents to read and review, keep paper to-do lists, and get our industry news in printed magazines.
Don't misunderstand my point here-the digital revolution has changed the world in profound and mostly positive ways. And newer add-on technologies continue to add organizational and efficiency benefits. For example, OnFolio is a product that integrates with your Web browser and allows you to "file" Web pages, emails, Word documents, PDFs, and other documents in tidy folders available at a moment's notice.
But the paperless office is simply a myth today, and will remain so for the remainder of our lifetime. And this isn't a bad thing. Why is paper so stubbornly resistant to extinction? First of all, paper is just a wonderful thing to use. It is easy on the eyes, nice to hold, carry, and about as portable as an information technology can be. It is relatively inexpensive and reasonably well made-paper can last centuries. Aside from writing on the paper, there is a world of additional information that can be obtained from it-the quality of the paper, whether it is wrinkled or not, even the presence of coffee stains. Paper is comfortable for us to read, wherever we go.
If we get all this from paper, what is the real value of an electronic office, anyway? Let's look at some of the value that can be realized nowadays, without the "all-wired" process in place.
The most important value of electronic document management in today's office is access to data and information. We are currently at a conceptual juncture in this regard. There are two basic ways to look at data/information access. The first is the organized filing of electronic documents, a task that requires some discipline up front. People who are good at this also have very neat paper files. Computers make this task very easy; they automatically alphabetize, structure, back up, and maintain data. Think about the automated organization of the Palm Pilot or the soon- to-be-ubiquitous Blackberry compared with the Filofax paper organizer. The electronic organizers don't have crossed-out or illegible entries, and are backed up with a touch of a button.
The filing metaphor can yield very valuable tools for organizing data and documents. OnFolio works well with this structured approach to document management. The tool leverages a key value of electronic document management, right on the desktop.
The second paradigm of data/document access is the harvesting of unstructured data. Many of us have too much data to manage in nice, neat folders, or too little time to do so. Our email inbox is cluttered, and our documents have proliferated in many different folders. Digital technology has a solution for this as well. One of Microsoft's most recent acquisitions is a two-person company making a product called LookOut, a cleverly named Outlook plug-in. This tool searches Outlook email, attachments, and desktop documents lightning fast (Microsoft no doubt plans to add this to the next version of Outlook and/or Windows, to replace its current sluggish and limited search engines. Until then, it had decided to stop distributing the LookOut tool. The result was uproar from the army of users who discovered it by word of mouth. It is now available for anyone to download and install: http://sandbox.msn.com/). The LookOut tool is one of several tools that work within the search paradigm of unstructured or partially structured data.
Electronic documents also have an internal structure that is unique-the hyperlink. The lowly and common hyperlink is the fundamental development that caused the "Internet Revolution." First brought to commercial life by Apple in a little program called Hypercard, the hyperlink allows you to reference and cross-reference within and between documents. Another less structured version of internal information organization within a document, the eXtensible Markup Language (XML), allows unstructured content within a document to be explicitly tagged for later retrieval/repurposing.
One benefit of electronic documents over paper is the ability to facilitate collaboration in a group setting. Software developers are well aware of the importance of check-in/check-out functionality in the management of code development. Document management software with this capability, ranging from source code management products to enterprise document management solutions, uses check-in/check-out to ensure that each document has a single "thread" and all modifications occur only to that thread, and not "branches" of documents. The thread can only be owned by one person at a time, and any changes made by that person can be tracked explicitly. Again, this is a structured paradigm of collaboration.
Microsoft Office (especially Word) has a less structured form of collaboration, whereby anybody can review, comment, and modify a document. The owners of the document can integrate these modifications and comments into a single final document under their own control, choosing to include them if so desired. Thus, the Word collaborative review is a group process that is less structured, but paradoxically requires more discipline to use.
Electronic documents can be used in large scale very differently from paper. Electronic documents can be shared in great numbers by email, ftp, Web site postings, and other innovative methods. Major advances in physics are available to the community weeks to months before they are published; this method of peer communication and review has become incorporated in the very fabric of academic communities. The "blog" phenomenon of personal Web page commentary has created a new form of journalism so influential that bloggers were awarded press entry into the U.S.'s recent Democratic and Republican Conventions.
These benefits of electronic documents-data access, group collaboration, and scalability-are the compelling value behind the universally adopted electronic office. Have they eliminated paper? Certainly not. Is there much, much more that can be added to make the process truly paperless? Certainly. The more relevant question is, should we wait for these things to happen before we replace a fully paper-based process with a fully electronic one? The answer, apparent to anyone with a pulse nowadays, is that the world has already adopted an imperfect and incomplete electronic paradigm.
Paperless clinical trials
As mentioned at the beginning of this column, some look at the advances of clinical trial technology and point to the missing pieces-fully electronic source, integration with health care records, streamlined regulatory document workflow, and complete integration of the document and data flow from protocol concept to submission. All of these are very interesting and valuable goals for electronic clinical trials. If they can be fully implemented, it may even be possible to completely eliminate paper from the clinical development process. This complete vision is unlikely to be implemented by any pharmaceutical or vendor company for some years. But failure to achieve this laudable vision shouldn't deter anyone from embracing the existing technology and moving forward. Why? Because the current electronic clinical trial technology has compelling value, just like the imperfect electronic office does.
In fact, the values are parallel to those already discussed-data/information access, group collaboration, and scalability. By centralizing the collection, management, review, and submission process of clinical trial data and documents, co-workers around the globe have immediate and robust access to critical information. Information access can protect patient safety in clinical trials and speed the process of data review, document review and regulatory submission. These groups work together through increasingly distributed but connected applications in a group collaborative process. These distributed applications are being designed for the scale needed to perform the largest, most complex tasks in clinical development.
If there is compelling value of electronic management of data and information in clinical development, why has the pace of adoption not been that of the electronic office? Many have speculated about industry conservatism, the regulated environment, and other industry-specific factors. Another important factor is the difference in individual and group decision-making versus enterprise decision-making. Components of the electronic office were adopted and could be used individually. However, most of the technologies that automate the data/document process in clinical trials can only be used in groups or enterprise-wide. The decision process is more complex, and the stakes of success are higher.
As with the paperless office vision, there will always be those who suggest that the real value of clinical trial technology is in the complete elimination of paper. This vision threatens the very real value that is available today.