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[The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry].
Med Clin (Barc). 1992 Jun 13; 99(3):106-9.MC

Abstract

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.

Authors+Show Affiliations

Departamento Médico, Hoechst Ibérica, SA, Barcelona.No affiliation info available

Pub Type(s)

Journal Article

Language

spa

PubMed ID

1630197

Citation

Segú, J L., and J Lahuerta dal Ré. "[The Norms for Good Clinical Practice in Drug Trials Performed in Spain. a Survey of the Pharmaceutical Industry]." Medicina Clinica, vol. 99, no. 3, 1992, pp. 106-9.
Segú JL, Lahuerta dal Ré J. [The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry]. Med Clin (Barc). 1992;99(3):106-9.
Segú, J. L., & Lahuerta dal Ré, J. (1992). [The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry]. Medicina Clinica, 99(3), 106-9.
Segú JL, Lahuerta dal Ré J. [The Norms for Good Clinical Practice in Drug Trials Performed in Spain. a Survey of the Pharmaceutical Industry]. Med Clin (Barc). 1992 Jun 13;99(3):106-9. PubMed PMID: 1630197.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry]. AU - Segú,J L, AU - Lahuerta dal Ré,J, PY - 1992/6/13/pubmed PY - 1992/6/13/medline PY - 1992/6/13/entrez SP - 106 EP - 9 JF - Medicina clinica JO - Med Clin (Barc) VL - 99 IS - 3 N2 - 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. SN - 0025-7753 UR - https://www.unboundmedicine.com/medline/citation/1630197/[The_norms_for_good_clinical_practice_in_drug_trials_performed_in_Spain__A_survey_of_the_pharmaceutical_industry]_ L2 - https://medlineplus.gov/clinicaltrials.html DB - PRIME DP - Unbound Medicine ER -