[Qualitative analysis of the perception of people who participate in a clinical trial, Navarra].

BACKGROUND

The objective of this study is to explore the perception that participants in a clinical trial have about the information disclosured by the physician, during patient recruitment and along the study as a preliminary stage for drafting a questionnaire.

METHODS

Qualitative study by means of quasi-structure interviews to subjects of different features taken from a patients list obtained by randomized selection of participants in clinical trials approved within the 1998-1999 period. For conducting the interviews, a guide was prepared based on the recommendations of the Helsinki Declaration.

RESULTS

Six (6) interviews were held with 7 individuals, as one married couple was interviewed. Most of the categories encountered belonged to the Helsinki Declaration. In addition, others being related to the fulfillment of expectations and to the balance of the risks/benefits done by the individuals for deciding to take part in the study.

CONCLUSIONS

The patients were acceptably informed of the most points dealt with under the Helsinki Declaration. The existence of lacking areas having a major impact on the fulfillment of their expectations however having been revealed.