This article adds to debate on the heavy lack all over the European Union of the required diligence and transparency regarding the registration in publicly available databases of research clinical trials and their results. This gap undermines patients’ right to an equitable access to health while jeopardizing financial resources for research
By Daniele Dionisio
The Evil of Unregistered Clinical Trials in Europe
On April 30th, 2019, Transparimed, BUKO Pharma-Kampagne, Test-Aankoop and Health Action International-HAI released the joint report Clinical Trial Transparency at European Universities: Mapping Unreported Drug Trials.
The report points the finger at documented non-fulfilment all over the European Union (EU), including Italy, of due diligence and transparency regarding the registration in publicly available databases of research clinical trials and their results. Non-fulfilment here runs contrary to the human right to equitable access to health and puts financial resources for research at risk.
Admittedly, trials results are instrumental to allow doctors, patients and policy leaders to make informed choices including relevant to the safety and appropriateness of therapeutic interventions. As such, sharing methods and results of all clinical investigations does represent a scientific and moral duty.
How to contextualize the reported gap inside the EU regulatory system? In a landscape characterized by various and complex local/national situations, the European Medicines Agency – EMA runs the EU Clinical Trials Register–EUCTR where clinical trials, once notified by the sponsors as completed, are put in following input by national (AIFA in Italy) regulatory agencies.
As an integral part of – and parallel with – EUCTR, EMA also runs the EudraCT database open to insertion, by the sponsors and national regulatory agencies, of updated data relevant to in progress clinical trials. Once ratified by the sponsors and completed, trials enter inclusion route in EUCTR.
Unfortunately, these rules suffer from disregard in Europe, as the just released joint report tells us. For example, as regards Italy’s low ranking in the report, we know that once a trial is approved, notification to AIFA is required for insertion in AIFA’s national register of clinical studies. As such, and consistently with the EU system, it should be incumbent to AIFA register and sponsors to pour registration and results of Italian clinical trials directly into EudraCT. With how much completeness and sense of timing has this being happened so far? This is a well-grounded question in the light of the joint report results.
In any case, the gap of trials registration in EUCTR, far from being circumscribed to the present time or a few countries, actually strikes transversely with the majority of accountable national bodies in Europe being defaulting.
In spite of non-stop blaming by several studies in recent years (including the one by Christine Schmucker et al. published on PLoS One in 2014), the problem has long been overlooked by the media, nor has it raised enough attention by the European Commission and national governments as well.
Last year, finally, an exhaustive analysis by Ben Goldacre et al. on the British Medical Journal achieved (also thanks to a tireless pressure on the media by Till Bruckner, TranspariMED Director) widespread international success, and paved the way for a seemingly just in motion reawakening of policy makers’ consciences from inaction.
In a wider perspective, and now that a silver lining looks like it would emerge in Europe, can long-term forecasts be possible? Unfortunately, no happy ending can be counted on at a time when governments must keep on being strictly pro-active and alert so that all involved parties comply with their duty to make trials data fully accessible to citizens, health professionals and researchers.