- A report by Salud por Derecho, Universities Allied for Essential Medicines (UAEM Europe) and TranspariMED claims that many clinical trials in progress are studying the same drug.
- The lack of transparency in publishing data and results is particularly worrisome, a pending subject in Spain that is essential for advancing in the research of drugs and vaccines for Covid-19.
- Almost half (44%) of the people in charge of clinical trials in our country are not publishing the results of their studies.
The Covid-19 pandemic has led to unprecedented financial backing for research and development into drugs and vaccines. Nonetheless, in Spain research is being duplicated and overlapping, according to the report Clinical Trials in Spain: Covid-19 Transparency and Research. It is being published today by Salud por Derecho and the international organisations Universities Allied for Essential Medicines (UAEM Europe) and TranspariMED.
According to data from the Spanish Clinical Trials Registry (REec, in its Spanish acronym) through 1 October 2020, there have been 123 Covid-19 related trials in Spain. The trials assess 76 different products. Of these, 91% (113 trials) analyse pharmaceutical drugs, whether for Covid-19 or its complications. Despite this, the lack of diversity of the drugs assessed and the high number of trials on the same drugs are extremely alarming. This is the case for hydroxychloroquine, present in 20 different trials.
These data point to the fact that Spanish clinical research initiatives on Covid-19 may be fragmented and duplicated. ‘The proliferation of small clinical trials on a single drug does not seem like the most effective way of creating knowledge and contributing to making fast progress to fight Covid-19. Conversely, we run the risk that this scattering we are seeing reveals squandering of research resources,’ warns Eva Iraizoz, Salud por Derecho researcher and co-author of the report.
Alarming lack of transparency
The study also focuses on the transparency of trials at a time like the present during which information on studies being conducted is essential for advancing in new therapies, diagnostic tools and vaccines. According to regulations in force, test authorities are obligated to submit a report on results to the EU Drug Regulating Authorities Clinical Trials Database (EudraCT) within 12 months after concluding the research.
However, an analysis of this EU registry in October 2020 reveals that noncompliance with this timeline is commonplace. In our country, the 32 main Spanish clinical trial authorities (organisations that have registered over 15 trials) have conducted a total of 1036 trials. Of them, 142 were finished over one year ago and, thus, their results should have been published. However, only 56% (80) have done so. In other words, 44% of the trials whose results should have been made public have not done it.
Of the 32 authorities analysed, only three have accurately complied with the requirements of European transparency standards. Another five have only published some of their results and the rest have published nothing.
Bearing in mind this track record, the study points out the need for exhaustive monitoring and follow-up of all Covid-19 research to ensure that research funds are not squandered. It also stresses the importance of having access to the results of each and every one of the clinical trials to be able to combine them, including those with negative or incomplete results, so that researchers can have an exact and accurate vision of the benefits and drawbacks of the medicines analysed.
‘Our study has proven that biomedical research transparency is still a pending subject in Spanish R&D policies. Even in open-access databases – like the Spanish Clinical Trials Registry – there are lack of information and inaccuracies at almost all levels. Taxpayers, patients and researchers deserve to know the data on research that is state funded and conducted at public hospitals and research centres,’ asserts Irene Romero, doctor and co-author of the study and member of UAEM Europe.
In accordance with the data available and the analysis performed, Spain is much less transparent in this area than other European countries like Austria, Denmark, Germany, Ireland and the United Kingdom. ‘In Spain, many patients still have to wait two or three years for the results of medical research to be publicised, if they are ever made available to the public. This negatively affects all patients, whether they have Covid, cancer or depression. Other European countries claim that the companies and institutions conducting drug trials do follow the regulations. Spain can and must do the same,’ claims Till Bruckner, report co-author and founder of Transparimed.
The report sets out a series of recommendations to improve the compliance and transparency of clinical trials, like those for financial institutions, including the Carlos III Health Institute – which received over 30 million euros in public funding when the pandemic started – to ensure that the organisations receiving subsidies publish their results, as established by regulations.
It also calls out for the Spanish Agency of Medicines and Medical Devices (AEMPS), in its function as the regulatory body, to monitor and provide those in charge of clinical trials with the resources needed to improve their transparency. It also stresses that in 2021 the EU regulations on clinical trials will enter into force, which will give it the power to impose fines on institutions that do not update results, due to which the AEMPS should implement the mechanism to activate the sanctioning process as soon as possible.
Report available at this link.