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GUEST EDITORIAL |
9 Bennington Road, Morristown, NJ 07960, USA
KEY WORDS: Technology transfer • clinical trials • periodontitis
How much and what type of information do we need to make a decision? This question came to me while I was sitting in a restaurant during a recent visit to London. I was situated such that I was able to watch people's behavior as they came up to the door and inspected the menu posted adjacent to it. Being mostly tourists, they were clearly unfamiliar with this particular establishment—some perused the menu briefly and then went to check out the restaurants across the street, others consulted with their companions, and still others pondered the menu for what seemed to be a prolonged period while, at least figuratively, scratching their heads. Ultimately, several of these individuals came in and enjoyed dinner. Since a menu usually contains only a limited amount of information, it would be interesting to speculate on the factors leading to the decisions made.
When it comes to the incorporation of new technologies into clinical practice, similar types of questions might be asked. How much information and what kind of information does the average practitioner require to decide to utilize a new technology or treatment modality? What are our roles as investigators, educators, and marketers in providing such information? Given the differences in knowledge and experience between the investigator/producer of a product and the practitioners expected to utilize the product, to what extent do we anticipate and satisfy the practitioners' needs? And what impact will the answers to these questions have on the ultimate success of new technologies in the marketplace?
Many companies have experienced frustration in not being able to market successfully new pharmaceuticals for the treatment of oral diseases, for example, for conditions such as periodontitis. I've heard this ascribed to the fact that "dentists aren't yet ready to accept pharmaceutical therapies". While it is true that some degree of education and preparation is necessary in this regard, perhaps part of the difficulty relates to the type of information about a product's efficacy which is provided to the practitioner at the time of product launch and the degree to which those data are compelling arguments for utilizing the product. And herein lies the crux of the problem. Companies investing in the development of new technologies understandably want to get their product to market as quickly as possible, to begin to recoup costs and, ultimately, make a profit. Studies demonstrating a product's effectiveness are generally done on the most inclusive patient populations, to allow for the broadest possible indications and marketing claims. Results are generally expressed as means of the patient groups studied and therefore may not be adequately informative about a product's true potential. In the case of periodontitis products, for example, because of the nature of the distribution of severely involved and lesser involved sites, the differences between the new technology and controls may not be overly impressive, often in the range of tenths of millimeters. However, it is likely that the new technology could have greater effectiveness in certain subsets of patients or sites. Thus, information concerning specific patient populations for which the technology is especially indicated and/or the proper place for incorporating the technology in the course of therapy would not only be more persuasive but also result in a higher probability of successful outcomes when the product is actually used in practice. The paradox is that while studies providing such information could be instrumental in helping to ensure the ultimate success of the product, there are frequently cost and time inhibitions which preclude their being conducted prior to product launch. As a result, potentially effective products can be commercial failures because practitioners are not provided with information which will help ensure beneficial therapeutic outcomes.
Over and above this, one must consider the question of clinical (vs. statistical) significance. This is a question which is also not readily resolved and which is the subject of much debate and even Talmudic reasoning. Yet, practitioners should be given a compelling reason for adopting a new technology which relates to demonstrably more favorable outcomes in their management of oral disease. Again, what is persuasive to those conducting cutting-edge research in a field might not be terribly compelling to the practicing dentist. For example, during a recent discussion, a periodontist colleague argued that a periodontitis product could be useful in practice because it "stabilizes" or "arrests" the disease, preventing it from progressing. Interestingly, periodic scaling and root planing and even periodic reinforcement in plaque control have also been shown to prevent disease progression. Therefore, while the concept of arresting disease may be of interest to an individual expert in the subtleties of pathogenesis and treatment of the various forms of periodontitis, is this rationale for using a new technology really compelling enough to the average practitioner, who is likely to have expectations of greater improvement? If an anti-hypertensive medication were promoted on the basis that it "stabilizes" the condition, thereby preventing a patient with a blood pressure of 170/100 from getting worse, would anyone prescribe this drug? Although in this discussion I have used periodontitis as an example, the concepts could also be applied to other oral conditions and technologies.
To return to our original questions, the successful introduction of new technologies into routine clinical practice would appear to require not only effective products, but also the appropriate data and educational underpinnings to underscore their usefulness to the average practitioner. The ability to generate this kind of information, however, can be at odds with the economics of product development and marketing. To bring our basic research findings effectively to the clinic and advance the practice of dentistry, we should seek ways to resolve these paradoxes and dilemmas by bringing together viewpoints and ideas from investigators, practitioners, and representatives from industry, NIDCR, and FDA. Perhaps this will lead to new, innovative study designs and/or methods of data analysis. This is something in which we all have a stake. The IADR/AADR could have a role in facilitating this process!
Received June 18, 2001; Last revision August 3, 2001; Accepted September 7, 2001
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