During the past decades, the innovations in ophthalmology have been a highlight in all of medicine. The development of modern techniques for cataract removal and IOL implantation, new vitreoretinal surgical and medical therapies, the evolution of refractive surgery—both corneal and intraocular—and more recently, corneal collagen cross-linking and new surgical approaches to glaucoma are promoting ophthalmology to a higher level than ever before.
THE PROCESS OF INNOVATION
Innovation has a process. First, a creative idea and a creator capable of transforming it into a real application are needed. Next, the idea has to be put into action. Eventually, a clinical trial should demonstrate (or not) that the new method works for the purpose for which it has been created, and the trial should investigate the potential limitations, complications, or insufficiencies of the treatment for the control of the disease or anomaly for which it has been created.
Traditionally, the United States has been considered a relatively hostile or at least difficult environment for medical innovators due to the many limitations that are imposed by the FDA. When I lived in the United States during my training, I witnessed the difficulties involved in the process of transforming an idea into a real application and the huge costs involved. For these reasons, many clinical innovations have gone outside the United States for further development.
HOW IT WORKS IN EUROPE
In Europe, with a more reasonable medicolegal environment and an open approach to the application of new therapeutic techniques, innovations have been fostered, and investigators have played key roles in the development and application of many of them.
The advantages regarding innovation in Europe are clear: regulations foster new ideas, and people are more open to participating in advances. There are disadvantages in Europe as well, such as a lack of focus on vision research. I believe the concept of vision research needs an independent body to drive it in the European Union (EU), similar to the US National Eye Institute. Translational research suffers from a lack of active innovative laboratory research and a lack of an organized, well-funded, uniform policy for clinical research. Fragmentation in the EU and the lack of integrated research create a limitation for clinical trials, which counterbalances the advantages in some countries.
Despite these limitations, the EU offers a positive environment for clinical trials. Patients want to included in clinical trials, and they have a positive attitude toward medical research in general. One of the key factors in the present and future development of clinical research in Europe is the EVICR or European Vision Institute Clinical Research Network (www.EVICR.net). The EVICR. net, led by José Cunha-Vaz, MD, in Coimbra, Portugal, was created about a decade ago to bring together clinical centers in Europe interested and active in integrated clinical research. The goal is to create uniform standard operating procedures and certification in clinical research to qualify investigators, to certify processes related to the use of special technologies and therapies, to train researchers, and to assist in clinical investigations. This unique network is being reproduced in the United States.
As I am involved in the creation of the EVICR.net project, I have observed the evolution of the concept and its importance in global ophthalmic research. Studies are performed according to the expertise and the capabilities of each center, and various centers have different areas of specialization and focus. All of the participating centers are certified for clinical research and monitored by the general organization.
In general, Europe provides an opportunity for clinical research. Different countries may have different attitudes and laws, but an innovative company might find real opportunities to develop ideas into practice through the EVICR.net. More flexible and tolerant laws, although strict enough in terms of ethics and scientific merit, offer opportunities for clinical research in the EU. Europe will remain an area of preference for the development of innovations in the future, as the professional and scientific standards, strict adherence to the protocols, and patients’ compliance are inherent in the European patients’ culture and the doctors’ education.
Jorge L. Alió, MD, PhD, FEBO, is a professor and the chairman of ophthalmology at the Miguel Hernandez University, Alicante, Spain, and the medical director of Vissum Corporación in Spain. Dr. Alió may be reached at +34 96 515 00 25; email@example.com.