Spain Leads Europe in Clinical Trials as REec Reaches 10,000 Published Studies
The Spanish Registry of Clinical Studies (REec), managed by the Spanish Agency of Medicines and Medical Devices (AEMPS), has reached a significant milestone by publishing its 10,000th clinical trial. In 2023, Spain became the leading country in Europe for the number of clinical trials initiated, with 485 new studies. This achievement reflects Spain's active role in clinical research and its commitment to providing valuable information to both patients and healthcare professionals.
A Resource for Transparency and Participation
Established in 2013, the REec offers a continually updated, accessible, and free database of clinical trials and observational studies authorised in Spain. It serves as a primary source of reliable information, allowing users to search for studies by disease or location and to contact sponsors and participating centres directly. This facilitates patient participation and supports healthcare professionals in staying informed about ongoing research.
Balancing Progress with Challenges
While Spain has made notable strides in attracting and initiating clinical trials — ranking first in Europe for studies commenced — the journey is not without its challenges. The AEMPS recognises the need to improve efficiency in the clinical trial process, particularly in reducing the time it takes for innovative treatments to reach patients after trial completion.
Currently, there is an average delay of approximately 661 days — nearly two years — for new medications to become widely accessible to patients following the conclusion of clinical trials. This lag exceeds the timelines stipulated by both European and Spanish legislation and highlights an area where AEMPS is focusing its efforts to enhance performance.
Commitment to Improvement
Efforts are underway to streamline procedures and reduce bureaucratic hurdles. Proposals include establishing early access programs for medications that offer significant clinical benefits and revising pricing and reimbursement systems to expedite availability. These initiatives aim to align Spain's strong performance in clinical research with timely patient access to new therapies.
The Role of Collaboration
Spain's progress in clinical trials is bolstered by collaboration between public institutions, private industry, researchers, and patients. The AEMPS emphasises the importance of this cooperation in advancing medical research and is dedicated to maintaining transparency through the REec. By publishing summaries of trial results, including those intended for laypersons, the agency fosters an environment of openness and continued scientific inquiry.
Looking Ahead
The milestone of 10,000 published clinical trials signifies a robust research ecosystem in Spain. As AEMPS works to address existing challenges, particularly in speeding up access to innovative treatments, the focus remains on enhancing the overall efficiency of the clinical trial process. This balanced approach seeks to ensure that advancements in research translate more swiftly into tangible benefits for patients.
Written by Jorge Ferrer
Decisive Dialogue 5th November 2024
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Contact us at enquiries@decisiveconsulting.co.uk to learn more about our expertise in P&R submissions and Health Technology Assessments (HTA).
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