Switzerland’s Roche has announced plans to establish what it calls a clinical trial protocol registry, which will contain information about its new Phase II to Phase IV studies, as well as a database that it says will show “key results” from completed trials.
The firm claims that with the registry and results database it would be possible to better coordinate the data it publishes, adding that the process will ensure that “ultimately, there is one global source for all Roche-sponsored clinical trial data.” The two new systems, which will be hosted by an as-yet unnamed “independent, neutral entity,” should be available to the public by the end of the first quarter of 2005.
Explaining the rationale of the move, Ed Holdener, head of global pharma development, noted: “Transparency on the results of its clinical studies has always been important to Roche,” adding: “At the same time, it is important that we protect the safety and the rights of patients, and secure the quality and integrity of the data and related conclusions.” He concluded by stating: “This clear and transparent approach is in the best interest of all parties involved.”
The announcement comes after the world’s pharmaceutical companies, through their respective international associations, recently promised to make results from clinical trials of new drugs publicly available, regardless of the outcome [[07/01/05a]]. Other companies have publicly stated that individually they will publish trial data, notably Merck & Co [[06/09/04e]], GlaxoSmithKline [[02/09/04a]] and Eli Lilly [[04/08/04b]].
However, high-profile critics, such as the British Medical Journal, have been less than impressed by the voluntary nature of these firms’ proposals [[17/01/05e]], and cynics have argued that the moves are little more than a knee-jerk reaction to criticism of the US Food and Drug Administration about the safety over certain drugs. Roche itself had a recent run-in with the agency over its controversial acne drug, Accutane (isotretinoin) [[24/11/04f]].