The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has teamed up with its Swedish member association, LIF (Läkemedelsindustriföreningen, the Swedish Association of the Pharmaceutical Industry), to introduce a new integrated search facility for clinical trial data.
The technology platform, which is being pioneered through the FASS medicines information website operated by LIF, enables visitors to country-specific websites to search in their own language for online clinical trial information using the IFPMA Clinical Trials Portal search engine.
Launched in September 2005, the IFPMA portal already provides search facilities in English, French, German, Spanish and Japanese. With its new technology package, said director-general Dr Harvey Bale, the Association could help other health information websites – including those run by medical and patient organisations – to offer a similar search capability to the FASS site in any languages covered by the MedDRA or MeSH medical dictionaries.
Searches in Swedish
FASS site users now have access to a local clinical trials search interface that allows them to enter multiple search criteria in Swedish. The search is then executed by the IFPMA Clinical Trials Portal, which will generate short summaries and links to relevant trial information. While the summaries are usually available only in English, the new platform will help Swedish visitors to understand them by providing Swedish-language explanations for a wide range of key medical terms.
Speaking at a press briefing in Geneva to launch the Clinical Trials Portal interface, Per Manell, director of information systems at LIF, said the FASS website was one of the largest of its kind in Sweden, receiving four to five million visitors a month. Of these, 40% were from the general public and the rest were healthcare professionals.
The integration of the IFPMA Clinical Trials Portal represented the third stage of a programme whose overarching goal was to make trial information as accessible as possible in as many languages as possible, explained Bale. The process kicked off in January 2005, when the main R&D-based industry associations agreed a platform for more systematic exposure of clinical trial data to the general public.
This included a registry with confirmatory details of ongoing studies, plus summary results of completed trials when a medicine was first approved. The associations also reserved the right to delay publication of data that might be commercially sensitive.
The IFPMA portal launched in 2005 was developed in conjunction with information technology leader IBM. Bale admitted the association ran into some technical difficulties with Stage 1 of the initiative, which offered English-only access to a limited number of clinical trials, using a basic search engine. Stage 2, introduced in March 2006, added multiple search criteria, including geographical locations, and incorporated the MedDRA and MeSH dictionaries of medical terminology to suggest synonyms, search for related terms and search in multiple languages.
The portal languages were also expanded at this point. As Bale pointed out, the addition of French and Spanish interfaces created “huge access” to clinical trial data for developing countries in Africa, Asia and Latin America, while also providing a vital tool for trial enrolment. The IFPMA Clinical Trials Portal was now getting around 12,000 visitors a month, he told the briefing. It supplied information on 35,000 to 40,000 ongoing clinical studies and some 5,000 sets of trial results.
Increasing transparency
While the IFPMA was swift to respond to gathering concern about lack of clinical trial disclosure, industry efforts to promote transparency in this area have also been criticised as too little, too late. The World Health Organization (WHO), which recently launched its own search portal giving access to clinical trial registries that belong to the new WHO Network of Collaborating Clinical Trial Registers, has called on pharmaceutical companies to register all trials – including exploratory studies with health volunteers – with full disclosure of key information in a centralised database.
The IFPMA has expressed reservations about such a wide-ranging initiative, though, arguing that a requirement to register early trials could “slow development or even prevent innovation in certain cases, without providing …benefit to doctors and patients.”
Asked about the WHO’s portal in Geneva, Bale said the IFPMA would be happy to step up collaborative efforts on this front, commenting; “We’re all in this together.” Nonetheless, the association had felt under an “obligation to act quickly” amid increasing pressure for clinical trial transparency, which meant the WHO’s capacity at this stage was “far more limited” than what IFPMA had achieved to date.
The association would also try to find ways of making its own portal even more accessible, Bale promised – although here he said the IFPMA faced its own capacity problems as a non-profit organisation, which might restrict the potential for adding new languages to the mix.