Roche approach and possible industry solution
Roche is taking a leadership role in the industry’s efforts to ensure transparency with its global approach, which is consistent with the information disclosure principles published earlier this year by the European Federation of Pharmaceutical Industry Associations (EFPIA).
The Roche strategy may model an industry-wide solution. Roche would support and participate in a future industry solution that provides a public database in which all companies can publish both national and international protocol information and trial results. Roche would be delighted if this independent solution would lead other pharmaceutical companies to use the CenterWatch repository to register ongoing clinical trials and report results of trials.
CenterWatch is a leader in web design and experienced in the implementation of websites for clinical trial listings and clinical trial results, and already has an established reputation as an independent source that the public trusts for clinical trial listings and results. Having CenterWatch host Roche’s clinical trials databases provides the widest possible exposure, and makes it easy for the public to obtain important information in this area.
Strict adherence to regulations of clinical trials
Roche works to ensure that all its activities are performed in accordance with ethical and regulatory requirements. Moreover, Roche is strongly committed to verifying adherence to compliance policies. Adequate and ongoing peer review is a key prerequisite for maintaining high ethical standards in Roche’s clinical trials and development activities.
In addition, Roche adheres to the “Declaration of Helsinki? a statement developed by the World Medical Association on ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Roche also strictly follows the rules of good clinical practice (GCP), which ensure