FDAAA TrialsTracker – a new administrative step or step towards scientific progress?

The watchdog website FDAAA TrialsTracker is a new automated tool which tracks the updates of clinical studies results on a daily basis. To be precise, it checks whether clinical trials comply with legal reporting requirements in the USA. The system has been launched on February 19 and it monitors whether the results of the trials registered on clinicaltrials.gov which are supposed to be reported by the Food and Drug Administration Amendments Act (FDAAA) actually comply with the reporting requirements.

Ben Goldacre, a director of the EBM Datalab and a co-creator of the TrialsTracker stated: « We wanted to build a standalone tool that looks specifically at the narrow, but very important, question of whether organizations, universities, and drug companies are complying with the FDAAA».

The initial aim of this system was to advance clinical studies reporting. However, audits conducted in last years found out the rate of compliance is extremely low – only about 20%. Goldacre adds: «There’s no evidence yet that the FDA, as far as I’m aware, are policing transgressions. I think if the government isn’t going to penalize people who fail to publish their trials, then public accountability is probably the best tool we have».

However, many researchers think that FDAAA TrialsTracker is not a step towards scientific process, it’s just a new administrative step. That is why they are sure that there is no point in doing it. Interestingly, many world-famous institutions, including Imperial College London, were mentioned in the list of organizations which do not comply with reporting requirements. Soon after being mentioned among non-compliant organizations, the College has updated clinicaltrials.gov with the missing data.

Source: The-scientist.