National Study Register obstructs transparency instead of promoting it

 

"Isolated national solutions in registering clinical trials won't create transparency for physicians, patients and the health care system but obstruct it, because they fragment the information. Those who wish to make the latest findings on each pharmaceutical available must rely on international databases," Cornelia Yzer, director general of the German Association of Research-based Pharmaceutical Companies (VFA), replied to today's demand for a national study register lodged by the Study Registration Initiative of the German Cochrane Center.

"Knowledge of pharmaceuticals is gained internationally, not domestically. The same pharmaceutical is tested in many countries worldwide, often in studies that extend across national borders. Efficient study registers must represent this fact instead of the small cross-section of activities within one's own national borders."

There are good reasons for publicly registering clinical trials with patients from the start and making their results publicly available at a later date, regardless of their success. This way, physicians could base their prescription decisions on all available information on a pharmaceutical. It is for this reason that the international pharmaceutical association IFPMA recommended to its members to register and publicize clinical trials. Most of the companies organized in the VFA already do so and others will soon follow. The companies have always created international online access to their information. They had good reasons for doing so: "The fact that studies initiated by companies would have to be re-register nationally whenever German medical institutions are involved will create neither more transparency nor increase pharmaceutical safety for anybody," Yzer said.

"Based on the good intention to create more transparency, many institutions have already created chaos in clinical study information," Yzer said with regret. There are already about 20 databases of studies in Germany, which are operated by various medical associations. "If every country on Earth now also gets its own register, the 'curtain of opacity' would be complete." It would be better, if the initiators of studies - including those for non-medication therapy - were immediately asked to register and publicize their studies in internationally established databases such as ClinicalTrials.gov.

Transparency with regard to pharmaceuticals and other therapeutic options could only mean that a search of a few databases would suffice for a complete overview, Yzer explained. As a result, the international pharmaceutical association IFPMA will open an Internet portal with search function for the public that will combine information about ongoing studies and results from completed studies on a given disease from various international databases. Furthermore, the VFA will continue to advocate that certain data fields from the existing EudraCT study register be transferred into the publicly accessible pharmaceutical database Europharm to be developed by the European Medicines Agency EMEA. Yzer concluded by saying: "Why reinvent the wheel if you only have to take it out of the garage?"

The German Association of Research-based Pharmaceutical Companies (VFA) is the trade association of the research-based pharmaceutical companies in Germany. It represents the interests of 39 globally leading research-based pharmaceutical companies and almost 100 subsidiaries and affiliated companies in the areas of health, research and economic policy. The VFA member companies make up about two-thirds of the German pharmaceutical market and employ approx. 85,000 people in Germany, including 14,500 in research and development.

Stand: 12.07.2005