María López is a freelance clinical research consultant and part of TrialHub’s network of country advisors. She has 25 years of experience in clinical research both in medical devices and drug clinical studies. Over the years she has held different positions: field clinical monitor, clinical research associate, clinical trial manager, startup associate, and clinical research liaison.
As a clinical research consultant, she frequently receives questions about local regulations, requirements for submissions to the ethics committee and competent authority, contracts, and customization of informed consent forms.
María agreed to share her knowledge about the clinical trials landscape in Spain in the past 2 years with our readers. Here is what to be aware of if you are considering Spain as a research destination.
Approvals in Spain don’t need annual renewal
As one of the main benefits of running trials in Spain, María cites the fact that Ethics Committee Approvals don’t expire until the end of the study. Unlike in some countries where approvals need to be submitted for renewal annually, in Spain the approval is valid until the end of the study. That is unless there is an amendment – then it should be submitted again to the Ethics Committee and Competent Authority.
Speaking of Ethics Committee – in Spain, there is no central EC and so you can choose which EC to go to. There are significant differences between ECs in the requirements, timelines, and level of success to get the approval in the first round of review. According to María, the EC fees might be cheaper in Spain too.
Clinical trial awareness among patients is growing
María notes that Spain is in the earlier moments of clinical trial awareness and there is still much that can be done to empower patient communities and organizations. She is starting to notice, though, a growing conversation on social media about the benefits of clinical trial participation and believes these awareness efforts will increase in the future.
If you are interested in running a clinical trial in Spain and would like to design a comprehensive patient recruitment strategy, keep in mind that there are advertisement restrictions. For example, you can post about your trial on Facebook, Instagram, and Twitter, however, Google ads are not allowed.
Speaking of Google, just as an interesting fact, there are 2,660 monthly clinical trial searches in Spain (population 46,754,778).
You can find all about digital patient recruitment as well as patient organizations in Spain on TrialHub.
Decentralized trials have been made easier
Compared to the US, GDPR presents a big challenge in European countries and Spain is no exception. So is remote SDV and monitoring, according to María. Solutions like eConsent and ePRO were used in some clinical trials in pilots but were not extended.
COVID-19 made so these solutions were allowed little by little as opposed to sending questionnaires, diaries, or consent forms by regular mail. At the beginning of the lockdowns, while some trials were put on pause or even canceled, others tried to manage some activities remotely – consenting with the exceptions allowed by AEMPS, Questionnaires, and PRO sent by regular mail or courier, medications shipped to patients’ homes.
Now, in María’s words, thanks to COVID-19 digital solutions are much more accepted in clinical trials and patients have begun to see their benefits as well.
If you’d like to know which DCT solutions are allowed or prohibited in Spain, you check out our DCT Regulations 2022 Report.
Although María notes there aren’t many local DCT solutions like home nursing (“There are remote HCP calls and Nurse calls or videoconferences, but I think there are not many local providers providing this service in Spain”), there are international ones with local coverage.
The future of trials in Spain
Since the start of the pandemic, there’s been an increase in the number of studies to be conducted in Spain. This is a trend seen across multiple countries and regions as COVID-19 marked a significant boost in clinical research. The boom in the industry, however, cannot be attributed only to COVID-19 trials.
María also notes that MDR requirements are making it mandatory for medical device sponsors to increase mid and long-term data collection to allow Notified Body CE Mark recertifications. Part of this data collection is what is called the PMCF studies (Post Market Clinical Follow Up Studies) – those could also be accountable for some of the increase in planned clinical trials in Spain. This trend will remain strong in María’s prognosis.
When asked about the future of clinical research in Spain, she sees 3 main directions:
- Decentralized clinical trials have arrived in Spain to stay just like the solutions associated with them (eConsent, ePRO, shipment of medication to patients’ homes, etc).
- Patient Associations and Networks will play a bigger role in the future in promoting clinical studies (possibilities to enroll, status, outcomes) and also in supporting screening activities.
- Patient Screening companies supporting Sponsors and CROs with methodology, tools, and resources to accelerate enrolment periods will continue to grow.
If these trends stay strong over the next few years, patients in Spain will benefit tremendously from the medical innovation that clinical trials bring.
Are you considering Spain as a clinical trial destination? TrialHub can support you with indication-specific data like recruitment rates, benchmarks, sites, startup timelines, and reimbursed drugs, as well as local insights. You can also find María López on LinkedIn.