The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has once again broadened the scope of mandatory clinical trial disclosure by its member companies.
The IFPMA’s updated Joint Position on the Disclosure of Clinical Trial Information via Cli
nical Trial Registries and Databases now extends to early-stage safety trials of medicines for life-threatening conditions, which are typically not conducted in healthy volunteers. Member companies will not be obliged to disclose information on Phase I safety trials in healthy volunteers – som
ething that was left to their discretion in the last version of the Joint Position.
The new version, which will take effect in six months’ time, stipulates that IFPMA member companies should disclose information on all clinical trials in patients as a minimum. Under the current Joint Position, dated 18 November 2008, information submitted to free, publicly accessible clinical trial registries or results databases must include, at a minimum, all confirmatory clinical trials and all exploratory efficacy trials.
When the current Joint Position was announced, IFPMA contended that disclosure of early safety trial information “cannot provide any useful insight into the potential efficacy of the compound trialled, but can make it easier for rival companies to gain an insight into the scientific approach of the company concerned”.
Earlier this year, a retrospective cohort study published in the open-access journal PLoS Medicine highlighted just how few Phase I trials see the light of day compared with other stages of clinical development.
Evelyne Decullier and colleagues from the University of Lyon, France and the Mayo Clinic in Rochester, US reviewed protocols for 444 clinical trials approved in France to determine whether and how the initiation, completion and publication of Phase I trials differed from the same outcomes for Phase II-IV trials.
They found that, by the time the data had been collected, just 17% of the 127 completed Phase I studies had been published in scientific journals, compared with 43% of the 218 completed Phase II-IV trials.
Even when the exercise was confined to trials with confirmatory results, only 25% of 71 Phase I trials had been published, versus 63% of 125 Phase II-IV studies. For around half of the Phase I trials, results were not made publicly available in any form, with confidentiality given as the main reason for sitting on the results.
Decullier et al saw a strong ethical imperative for eliminating publication bias from Phase I trials, commenting: “The testing of new pharmaceuticals on humans is approved by ethics committees based on the assumption that the inherent risks of trial participation are balanced by the benefit of new scientific knowledge for society. If this knowledge from Phase I remains hidden, then any potential risk incurred by trial participation is excessive and could endanger human lives”.
Publicly accessible
The new IFPMA Joint Position has already been approved by the other participating pharmaceutical associations, namely the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers’ Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Once the revised conditions come into force, member companies should post registry details of new clinical trials in patients on a publicly accessible website within 21 days of the start of patient enrolment, IFPMA says. Subsequently, they should publish summary results of any trial falling within the scope of the new Joint Position within one year of the relevant product first being approved and made commercially available in any country.
IFPMA’s own Clinical Trials Portal was launched in September 2005 (the first Joint Position was established in January 2005). The association recently added the myPortal facility, which allows users to request e-mail alerts when new trials are posted corresponding to criteria defined by the user.
