A review of the NIDCR/FDA Dental, Oral, and Craniofacial Technology Forum

As new discoveries emerge from the laboratory, clinical trials are crucial to develop these discoveries into the next generation of products. Successful clinical trials require effective collaboration between the NIDCR, the Food and Drug Administration (FDA), and industry. To promote this interaction, NIDCR and the FDA hosted the second Dental, Oral and Craniofacial Technology Forum, December 11-13, 2001 on the NIH campus. Organized by Drs. Bernard Janicki from the NIDCR and Edward F. Rossomando from the University of Connecticut School of Dental Medicine, and Dr. M. Susan Runner from the FDA, the forum was attended by more than 60 people, including representatives from Federal agencies, industry, professional and scientific societies, advocacy groups, and educational associations.

Following opening remarks by Lawrence A. Tabak, NIDCR Director, and David W. Feigal, Jr., director of FDA's Center for Devices and Radiological Health, Dr. Franklin G. Miller, Department of Clinical Bioethics, National Institute on Mental Health, delivered the keynote address. Dr. Miller spoke about "The Ethics of Randomized Clinical Trials," focusing on the importance of informed consent. A panel discussion of issues critical to the success of clinical trials then followed, led by Drs. Linda Niessen, Jorgen Slots, George Taylor, Thomas Van Dyke, and Alex White. The panel discussions served as a prelude to a unique interactive case study session in which attendees joined a team to study one of seven cases. This format helped highlight and clarify issues that need to be considered and solved to successfully perform clinical trials. Among the topics discussed were issues related to off-label use; surrogate end points, and drug/device combination products. Other topics included ethical issues when using human subjects, special statistical problems in dental clinical trials, and financial considerations in clinical trials.

Several outcomes related to clinical trial design emerged. In the regulatory domain, the complexity involved in obtaining FDA approval of technologies that are both devices and drugs was initially seen as a problem. But several teams presented strategies for addressing this issue. The emphasis on early "informal" contact with FDA was uniformly welcomed and supported. In addition, all teams emphasized the need for new well-defined guidelines for products that may require multi-center reviews. In the economic area, the magnitude of the costs of clinical trials was a major theme. The return on investment was discussed relative to the size of the dental market. One team focused on financial issues faced by small companies attempting to form an alliance to perform clinical trials on a new product.

In their reports, each team reiterated the need to evaluate market potential, production costs, and competitive advantage prior to initiating an expensive clinical trial. They also stressed that FDA and NIDCR should continue to work with industry representatives to facilitate clinical trials by standardizing criteria such that results are acceptable to both agencies and costly repetition is avoided.

Overall, the presentations emphasized that successful clinical trials are critical to launch new products and that NIDCR should explore novel mechanisms to partner with industry to encourage industry investment in development of new clinical products.

For a report of the Forum please contact Dr. Edward F. Rossomando at [email protected]