[The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry].
BACKGROUND
The objective of this survey was to assess the state of the art of the implementation of Good Clinical Practice in the Spanish Pharmaceutical Industry.


METHODS
A questionnaire was sent to the sixty first laboratories according to their sales of ethical products. In the questionnaire there were questions concerning nationality of the company, personnel in clinical research, use and characteristics of standard operating procedures (SOPs), auditing and quality assurance as well as questions in connection with the future implications of SOPs implementation.


RESULTS
The level of answer was 42%. Twenty one out of the 24 companies that answered the questionnaire had SOPs implemented. In total 150 clinical research projects were carried out in 1990. One hundred one out of this 150 were performed under GCP. Fourteen companies agreed that with their current structure were able to accomplish 100% of the projects with GCP. The most frequent estimation of cost increase due to GCP was 30% (min. 10%; max. 70%). In overall 26 external audits were performed in 1990. Twenty one laboratories stated that they had not acceptance problems of GCP among the investigators.


CONCLUSIONS
The sample seems to be representative of the Spanish pharmaceutical industry attitude with respect to GCP implementation. Although the exigency level was not detailed, around 42% of the clinical trials sponsored by the pharmaceutical industry are performed according to GCP. There is a positive impression as to the possibility to implement GCP as well as to the attitude of the investigators to this respect.
Segú
J L
JL
Departamento Médico, Hoechst Ibérica, SA, Barcelona.
Lahuerta dal Ré
J
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D002986:Clinical Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D004341:Drug Evaluation / Q000592:standards* / Q000706:statistics & numerical data; D004345:Drug Industry / Q000706:statistics & numerical data; D006801:Humans; D011786:Quality Control; D012108:Research Personnel / Q000706:statistics & numerical data; D013030:Spain; D011795:Surveys and Questionnaires; D000078329:Workforce
Normas de buena práctica clínica en los ensayos con medicamentos realizados en España. Encuesta a la industria farmacéutica.