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Clinical Trials in Spain – An Update

Posted on: 13 Mar 03


Would you do a clinical study in Spain? The immediate reaction of the majority of the international clinical research community is “maybe but only at the later stages (Phase III-b, Phase IV)”. Spain i
Introduction Would you do a clinical study in Spain? The immediate reaction of the majority of the international clinical research community is “maybe but only at the later stages (Phase III-b, Phase IV)”. Spain is one of these countries with a notorious reputation for bureaucracy ridden issues related to the clinical trial process. To a limited extent this is true however with the right knowledge and experience, running a study in Spain can turn out to be a surprisingly positive experience. Also companies are finding that earlier clinical development in Spain can provide positive return at the drug registration and marketing phases of drug development. Spain also has a large un-tapped clinical trial population with an extensive pool of enthusiastic and qualified investigators. Certainly, timelines are still an issue in Spain and that is linked to the requirement to detail with three distinct bodies: Ethics Committees, Hospital Administrations and the “Agencia Española del Medicamento” (AEM). These bodies have to be dealt with separately and each has there own problems. Table 1.- Approval Timelines Year 1998 1999 2000 Days (mean) 61.4 36.2 23.3 Source: Spanish Drug Agency (AEM) It is also true that all European countries will have to adapt to the new European guidelines which come into force in the coming years. The effect of this in Spain remains to be seen and it seems that so far there have been few advance preparations for the onset of the legislation. In theory, this will remove some bureaucratic hurdles but unless carefully planned, we may end up with a similar situation to the introduction of regional EC´s in the UK and the subsequent slowing down of the system. Table 2.- Clinical Trials submitted per year in Europe Country Clinical Trials submitted Germany 1300 UK 1000 Austria 1000 Belgium 500-800 Spain 500-800 Sweden 500-550 Finland 300 Denmark 320 Low Countries 200 Ireland 200 So what is the key to being successful in Spain?
  • Be clear of the issues before you start your clinical research
  • Work with a partner with local knowledge and Spanish speaking clinical staff
  • Provide rapid response to required documentation and review any requested changes in the light of national requirements as well as ICH/ GCP Legal Issues - Recent Advances / Changes Real Decreto & Circulars. Ethics Committees This is a common problem to any country whereby there is no legal requirement to meet regularly and this results in delayed review procedures for protocols, etc. Nowadays in Spain many EC are receiving more project than they are able to evaluate so, when a specific research unit has not been created , i.e. “centres from medium size cities” to obtain a quick approval is a concern. Things are changing gradually. Hospital Administration In Spain the hospital director also has to approve the study and this is usually an automatic procedure on the findings of a positive Ethics Committee approval. However they also require a specific contract that often is a their own template and this has to be legally reviewed by any sponsor. Significantly the content of these documents has been improved in recent years and tends to focus only on the legal requirements of the investigator and the financial effect on the institution involved. AEM There has been a great improvement in the time to approval due to a simplification in the submission process which has been implemented in recent years, however, it is still very open to political change. Each time the government in Spain changes, often results in a change of structure in the health ministry. This can have both positive and negative effects but there is always an interim period of uncertainty that results in delays of the procedure process. Several recent proposals have been implemented to streamline the process and some have been successful. Table 3.- Clinical Trials in Spain 1994-2000 Year 1994 1995 1996 1997 1998 1999 2000 Clinical Trials 331* 364* 454* 534* 535** 586** 572** *Submitted CT **Approved CT Source: Spanish Drug Agency (AEM) The Language Spain currently has an amazing language school industry, however, the percentile of English speakers is still low due to a poor early education strategy for learning foreign languages. This means that during the study set-up phase for Regulatory, Ethics Committees and Hospital Contracts can be a daunting experience for non- Spanish speakers. This can clearly be improved by using native speakers with experience in the procedures in Spain. Also, when selecting investigators the sponsor may often identify excellent clinical research physicians however the support staff of co-investigators and study nurses may have only limited understanding of English thus causing difficulties in the daily management of a study. Similarly for monitoring the study it is a clear requirement to have native speakers to review source data documentation. The Sponsor Sponsors are aware Spain occupies the fifth place in Europe and the seventh in the world in volume of pharmaceutical sales and this brings an increasing investment in R&D. Between 2001 and 2002, the Spanish pharmaceutical market grew by over 10 percent and is predicted to maintain a double-digit growth rate over the next five years. The growing attraction of Spain as a centre for R&D is illustrated by the fact that foreign companies now represent 75 percent of pharmaceutical producers in Spain. Quite often, many issues arise because the sponsor does not fully understand the clinical trial process in Spain and forgets that national legislation precedes the requirement for ICH. In Spain, the Regulatory procedure is very clear and strict and is at least as stringent as ICH therefore should provide no barrier for unworldly foreigners. The next paragraph give us the solution… The CRO It is important the CRO has direct experience in the country and the use of native speaking clinical staff is imperative. Most of the CROs situated in Spain, have expertise in arrange all phases of studies according to Spanish Regulation. The outsourcing for Clinical Research is the best tool for conduct a study in Spain or any other foreign country when the client is not familiar with Local Regulatory Affairs. A few Examples of common issues 1. Regulatory submissions: A notable improvement in timelines is being carried out successfully 2. Translations: Sponsors have to aware about having a Spanish mother tongue in their staffs. 3. Contracts: Each Hospital has its own model. A standard template for all centres would be impossible to achieve How to avoid the issues!! Take it easy and trust your CRO. Companies with no presence in Spain are often the most uncomfortable when running studies there as they find it difficult to cope with the specific procedures. The hardiest survivors are usually the multi-nationals who have run many studies over the years and put full trust for study set-up with the local affiliate. Summary During the last ten years, the quantity and quality of Clinical Trials in Spain have increased greatly, and this is only the beginning. Spain can be fun and think of all these wonderful cities that are only a step away Barcelona, Madrid, Seville, Granada, San Sebastian etc. You do not need to learn the language. With the right partner and a pro-active clinical team studies can be set-up on time with access to an important pool of clinical trial patients and investigators only to happy to be involved in clinical research.
  • Lewis Cameron

    Last updated on: 27/08/2010 11:40:18

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