Many clinical trials run in Spain – including numerous trials of Covid treatments – may end up as research waste and make no contribution to improving patient care or to scientific progress, a new report released today warns.
Salud por Derecho, a Spanish health group that co-published the report, is calling on Spain's medicines regulator to impose sanctions on institutions and companies that fail to make the results of drug trials public as required.
Eva Iráizoz, the group's Advocacy and Research Officer, said:
"Transparency and accountability are key for the progress of science in favor of patients and societies, especially now during the COVID-19 pandemic and in a context were a huge amount of public funds and research efforts are being put in place.
"It is urgent that all stakeholders in Spain ensure transparency on clinical research and make public clinical trial results. The AEMPS, as the Spanish regulator, must put in place all the means and efforts to support trial sponsors in this task and must perform a close follow-up of sponsors’ compliance, including sanctions when needed."
Irene Romero from Universities Allied for Essential Medicines Spain, who co-authored the report, said:
"COVID-19 is a flashlight pointing at the dark corners of Spanish research and development policies, showing that a lot of clinical trial data is hidden from citizens, physicians, and patients."
1. WIDESPREAD VIOLATIONS OF TRANSPARENCY REQUIREMENTS
Most Spanish institutions are failing to meet their obligation to make clinical trial results public on the European trial registry. Overall, the 32 largest sponsors in Spain have failed to fully make public the results of an estimated 395 long-completed clinical trials.
Only three of the 32 largest Spanish sponsors have a perfect compliance record: pharma company Almirall, Grupo de Tratamiento de los Tumores Digestivos and Grupo Español de Cáncer de Pulmón. All other Spanish sponsors with due trials in their portfolios do not fully comply with transparency rules.
The chart below shows the estimated number of clinical trial results missing for each of the largest 32 trial sponsors in Spain.
Fundació Clínic per a la Recerca Biomèdica accounts for the largest number of missing results (38), followed by Vall d'Hebron University Hospital (31) and Hospital de la Santa Creu i Sant Pau (30).
Note: Please see the full report for a data table, and the rationale and methodology for calculating estimates.
On the positive side, Vall d’Hebron has committed to uploading its missing clinical trial results, and its performance is expected to rapidly improve in the coming year. Future TranspariMED reports will track Spanish sponsors' progress over time.
Overall, trial reporting rates in Spain are far lower than in other European countries including Austria, Denmark, Germany, Ireland, and the UK. Spanish sponsors can use TranspariMED's collection of transparency tools to improve their trial reporting.
2. FRAGMENTED COVID RESEARCH LANDSCAPE
Many Covid trials in Spain appear to have been launched in an uncoordinated manner, leading to considerable fragmentation and duplication of medical research efforts.
By the start of October 2020, a total of 123 COVID trials had been registered in the Spanish Clinical Trials Registry (REec), many of them investigating the same drugs. Over half of those trials were funded with public money.
The proliferation of small and apparently uncoordinated clinical trials with overlapping research agendas in Spain is unlikely to contribute much to medical progress, and is likely to result in a high level of research waste.
3. ELEVATED RISK OF NON-REPORTING FOR COVID TRIALS
There is a high risk that the results of many Spanish Covid trials in particular will never be made public because many Covid trials in Spain (and elsewhere) are likely to be terminated early, often after treating only a small number of patients.
Medical journals are unlikely to show much interest in such trials, and journal publication timelines are typically very slow. However, it is extremely important for the scientific community to be able to rapidly access and combine the results of every single trial, even those with negative or incomplete results. In many cases, scientists will only be able to gain an accurate and reliable picture of a COVID drug’s benefits and harms by combining the results of many small trials, including trials that were terminated early.
The European trial registry provide a perfect platform for rapidly making public the results of all Covid drug trials, including the results of trials that were terminated early.
However, a TranspariMED report published in June 2020 found that out of 48 Spanish COVID drug trials listed on the European trial registry at the time, only two trials were being run by a sponsor that had a strong track record of uploading results onto that registry.
Today’s report was jointly published by Salud por Derecho, Universities Allied for Essential Medicines Spain, and TranspariMED.
Click below to download the full report (English and Spanish language versions available).
The report builds on and complements three previous publications:
1. Clinical Research in Spain: A Profile of Clinical Trials in the Spanish Registry
A June 2020 report by Salud por Derecho analysed data on the Spanish Registry of Clinical Studies (REec), a national stand-alone database not linked with the global WHO trial registry network, found widespread data gaps. Results for at least 122 trials were missing, in violation of national law.
2. Covid Clinical Trials in Spain – Fragmentation, Gaps and Duplication
A November 2020 report by Universities Allied for Essential Medicines Spain analysed data on 123 Covid trials registered on the Spanish Clinical Trials Registry (REec) up to the start of October 2020. It found considerable fragmentation and duplication in nationwide Covid clinical research efforts.
3. Research waste in European COVID drug trials
A June 2020 report by TranspariMED analysed data on 118 Covid trials (including 48 Spanish Covid trials) registered on the European trial registry by mid-May 2020. The report found that most Spanish trials were at high risk of research waste because they were run by sponsors with weak or non-existent transparency track records.