[Good clinical practices in clinical trials: the responsibility of the researcher. A survey of 827 hospital physicians (I). Availability. Monitoring. Safety. Contract].
BACKGROUND
The Law of Medicaments establishes that clinical trials (CT) with drugs must be carried out following the of Good Clinical Practice guidelines (GCP). The attitude of hospital physicians to the GCP prior to its implementation as mandatory in accordance with Spanish legislation was considered to be of interest.


METHODS
An anonymous survey was used with closed response questions. Questions referring to the responsibilities of the investigator included in the GCP were included. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members, of any specialty, who had or had not participated in CT. In this article the results of the questions regarding the availability of the investigative team, CT monitorization, management of adverse reactions, the safety of the participants in the CT and the contract between the sponsor and the researcher are presented.


RESULTS
A total of 827 hospital doctors replied to the survey. Fifty-nine percent had intervened in CT with drugs. At least 94% of those surveyed considered that the researcher must have the time and number of eligible patients which the CT requires. There was high acceptance (> or = 78%) of the clinical audits to be performed by the health authorities and the sponsor company of the CT. The need of urgent communication of the severe adverse reactions is admitted by a great majority (> or = 95%) of those surveyed. Eighty-five percent believe that patients should be insured against damage derived from CT with 76% considering that the investigator should sign a contract with the sponsor; 68% and 59% would hand in a copy of the same to the CT committee and the remainder of the research team, respectively.


CONCLUSIONS
According to the Good Clinical Practice dealt with in this article, the responsibilities of the investigator have been widely accepted by the hospital physicians surveyed, therefore no problems should be expected upon the implementation of the same in this country. However, the economic transparency in the clinical trial does not appear to be absolutely necessary by the doctors surveyed.
Dal-Ré
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Departamento de Investigación Clinica, SmithKline Beecham Pharmaceuticals, Madrid.
D000328:Adult; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003284:Contract Services / Q000706:statistics & numerical data; D016903:Drug Monitoring / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008505:Medical Staff, Hospital / Q000706:statistics & numerical data; D008875:Middle Aged; D010820:Physicians / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D012108:Research Personnel / Q000706:statistics & numerical data; D012449:Safety; D012941:Social Responsibility; D013030:Spain; D011795:Surveys and Questionnaires