German doctors press for a national trial register

A task force of German epidemiologists, doctors, and consumer protection campaigners is pressing for the swifter establishment of a national register of clinical trials.

At a press conference last week in Berlin the group said that it was in the interests of patients and medical science that Germany set up a register. The task force also published an appeal in the German Medical Journal Deutsches Ärzteblatt (www.aerzteblatt.de/v4/archiv/artikel.asp?id=47551).

The initiative is supported by an alliance of German medical organisations, including medical faculties, ethics committees, medical societies, the Science Council, and the German Medical Council. The German science ministry will fund the register, which is expected to be set up in the next three years. A final decision on where the register is to be based will be taken next year.

It is estimated that every year several thousand clinical trials are started in Germany, but most of them remain unknown to patients, doctors, and the scientific community until their results are published.

Only a few German studies are currently registered on the United Kingdom based International Standard Randomised Controlled Trial Number Register (www.controlled-trials.com) and the US ClinicalTrials.gov (www.clinicaltrials.gov).

“Many scientists and doctors in Germany are not aware of the fact that they will not be able to publish their studies in the main international medical journals unless they register the trials beforehand,” said Gerd Antes, head of the German Cochrane Centre at Freiburg University.

The main purpose of the German initiative is to make clinical trials transparent to patients, doctors, and scientists. It is hoped that mandatory registration will prevent unnecessary studies and the suppression of studies that produce negative results.

However, the German Association of Research-Based Pharmaceutical Companies, based in Berlin, condemned the initiative. Cornela Yzer, executive director of the association, said national registers lead to a lack of transparency, because they caused data to be split between different registers. She favoured the registration of all clinical trials on the international registers.

Dr Antes disagreed. He said, “International registers with unlimited access to all trials will satisfy research purposes. But they are not easily accessible to patients and general practitioners in Germany.”

He was also sceptical about the openness of international registers to all trials, because of the need to register a trial at its inception and because of the amount of information that the registers require.