Industry Supports Move Towards Increased Clinical Trial Transparency To Help Doctors & Patients To Facilitate Informed Treatment Choices

On the occasion of the International Clinical Trials Day Workshop, organized by the European Clinical Research Infrastructures Network (ECRIN) under the auspices of the European Commission and in collaboration with the WHO, the IFPMA reaffirms its support for enhancing clinical trial transparency, to help provide doctors and patients with useful information.


IFPMA Director General Harvey E. Bale said: "Greater clinical trial transparency serves very important practical purposes. The pharmaceutical industry is committed to making clinical trial information available to facilitate informed treatment choices and participation in clinical studies. To this end, the IFPMA has invested heavily to facilitate public access to clinical trial information available on the Internet."


The first stage of the IFPMA Clinical Trials Portal (ifpma/clinicaltrials) was launched in September 2005. An improved portal, offering a user-friendly, multiple-criteria, advanced search function in English, French, German, Japanese and Spanish, was launched on 22 March 2006. The portal accesses registry information on more than 30,000 ongoing clinical trials and summary results of more than 5,000 completed trials of medicines approved for marketing in at least one country - and the numbers are growing daily.


Prof. Jacques Demotes, Co-ordinator of ECRIN and a clinical researcher in Bordeaux, commented: "I have found that the IFPMA Clinical Trials Portal offers a quick and easy way of finding information about ongoing trials, and helps me inform patients willing to participate in clinical trials."


The IFPMA has worked to realize the objective of increased clinical trials transparency through both policy and practical initiatives. In policy terms, the IFPMA supports public disclosure of information on ongoing clinical trials that are designed to generate useful therapeutic information for patients and other stakeholders. The IFPMA also requires timely publication by its member companies of results of completed trials of approved medicines, as these help further inform physician and patient decision-making about appropriate treatments. The resulting public record also allows trials to be tracked to publication and facilitates wider patient and investigator participation. The IFPMA welcomes the WHO's recent deliberations on recommendations for a global approach to clinical trial registration.


Further dialogue between WHO, industry, regulators and other stakeholders is essential to develop sound policies for the benefit of patients. Industry suggests that flexibility must be incorporated in any final WHO recommendations, to help ensure registration of trials and to avoid inadvertently discouraging innovation. The IFPMA is very concerned that companies may refrain from conducting research and development in certain fields, if they feel they are obliged to provide competitors with sensitive information too early, or are unable to gain necessary legal protection for their innovations.















WHO is urging a standard that requires public registration of early exploratory trials. The potential implications of such a recommendation need to be considered carefully. This standard may slow development or even prevent innovation in certain cases, without providing informational benefit to doctors and patients. It is also important to acknowledge that full information on all clinical studies is always provided to regulatory authorities, ethics committees, investigators and patients who enroll in these studies. The IFPMA therefore urges that the WHO staff consult with regulatory agencies on the scope of trials to be registered, so that the benefits and risks can be assessed.


"The industry, represented at international level by the IFPMA and at EU level by the European Federation of Pharmaceutical Industries and Associations (EFPIA), has already done much to increase clinical trials transparency and stands ready to play a full and active part in discussions with the WHO and other stakeholders. The R&D pharmaceutical industry is convinced that it is vital to arrive at a policy which encourages and promotes trial transparency, without discouraging the development of innovative new therapeutic approaches", noted Dr. Bale.


About the IFPMA


The International Federation of Pharmaceutical Manufacturers & Associations is the global nonprofit NGO representing research-based pharmaceutical, biotech and vaccine companies and national industry associations in developed and developing countries. The industry's R&D pipeline contains hundreds of new medicines and vaccines being developed to address global disease threats, including cancer, heart disease, HIV/AIDS and malaria. The IFPMA Clinical Trials Portal and the IFPMA Health Partnerships Survey help make the industry's activities more transparent. The IFPMA strengthens patient safety by improving risk assessment of medicines and combating their counterfeiting. It also provides the secretariat for the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).


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