False ‘ongoing’ clinical trials make life difficult for patients and researchers. Now Britain’s MHRA
Thousands of clinical trials listed on the European trial registry are falsely marked as ‘ongoing’ when in fact they have been completed long ago.
This makes it difficult for patients to find trials to participate in, and difficult for public health agencies and researchers to gain an overview of the complete scientific evidence base on a medicine.
The proliferation of incorrect trial statuses directly undermines compliance with EU reporting rules.
At present, neither the European Medicines Agency nor national regulators (nor trial sponsors themselves, if they are badly organised) can tell precisely which trials are due to report results.
While the scale of the problem seems to vary between countries, each EU country currently appears to have a significant number of false ‘ongoing’ trials in its national portfolio.
Thankfully, this problem can be fixed.
In January 2019, the UK’s national medicines regulator MHRA decided to start tackling the problem. To date, the MHRA has successfully reviewed (and if appropriate, updated) the status of over 1,700 clinical trials.
The MHRA intends to continue working through its entire portfolio of thousands of clinical trials until the status of each and every clinical trial with at least one trial site located in the UK that is listed on the registry has an accurate and up to date status.
Based on the MHRA’s experience, 30 person-days of staff time are sufficient to update the status of 1,000 trials – a small investment that will significantly benefit patients and researchers across Europe for years to come.
Other national medicines regulators (National Competent Authorities) across Europe should follow the MHRA’s positive example.
In order to encourage and inform their registry clean-up efforts, TranspariMED today publishes a brief detailing how the MHRA is fixing the problem.