One of Spain’s largest trial sponsors is racing to make public all results of its drug trials by January next year.
Historically, Spanish institutions have performed weakly on clinical trial reporting, but registry data show that over the past year, some major Spanish sponsors have started uploading missing clinical trial results.
With 25 clinical trial results already uploaded onto the European trial registry, the University of Navarra is setting a positive example for other medical research institutions in the country to follow.
In this Q&A, José María Galindo Marqués from the university’s research support unit outlines their achievements to date, and the challenges that remain.
Q: When did the university start this process?
A: At the beginning of this year, advocacy group Salud por Derecho sent us their report showing that many Spanish clinical trials did not have results available on the European trial registry. Until then, we had not been aware that this was a regulatory requirement. We decided to start fixing the problem as fast as possible.
Q: How many results have you uploaded so far?
A: We have uploaded the results for 25 trials to date. We will upload the remaining 17 due results by January 2022.
Q: Why do these numbers differ from the numbers shown on the EU Trials Tracker website?
A: A few of our trials do not appear in the Tracker, or the results are not publicly visible. In some cases, this may be because these are Phase 1 trials. We are in contact with the EU Trials Tracker team to get these issues addressed. But the larger problem is that many of the trials with results are still listed under “not due” or “inconsistent data” by the Tracker because the trial completion status has not been completed, or there is no end of trial date in the trial protocol. This is information that we ourselves cannot change on the trial registry. Only our national medicines regulator can do that.
Q: What support are you getting from the national regulator AEMPS?
A: To date, our experiences have not been very positive. When we emailed the regulator, the regulator responded to us quickly as usual but the answers were vague or incomplete. This is something unusual that we only noticed with this particular issue.
Q: What other Spanish institutions are you in contact with on this issue?
A: There is no network in Spain where people can exchange experiences on trial reporting. We have been doing all of this work by ourselves, learning as we go along.
Q: Will you be able to upload the results for all trials, even very old trials?
A: Yes. We still have records from all of the old trials. We will not always be able to upload the results in tabular format, but the registry system allows us to upload final reports from older trials in PDF format. Some of those reports are in Spanish language, and we do not have the resources to translate all of those. But the results will be publicly available on the registry, which is the most important thing.
Q: Are you confident that you can complete the process by January next year?
A: Yes. It is an ambitious goal, but we will achieve it. At the end of January 2022, trial reporting will become a legal requirement across the European Union, and by then we will have reported all of our due results.
Note: Going forward, TranspariMED will produce a national report documenting Spanish trial sponsors' reporting performance on the European trial registry.
Previous relevant publications:
Large data gaps found in Spanish clinical trial registry REec (June 2020, report by Salud por Derecho)
Clinical Trials in Spain: Covid-19 Transparency and Research (Dec 2020, report by UAEM Spain & Salud por Derecho & TranspariMED)