The patient's experience of being a human subject

To explore the patient's experience of clinical research with a view to improving its conduct.

Qualitative analysis of focus groups, semi-structured telephone interviews and questionnaires undertaken with subjects of clinical research.

265 patients enrolled in two therapeutic and four non-therapeutic clinical studies were invited to take part. 95 agreed; 32 took part in focus groups, 34 in telephone interviews and 29 returned a questionnaire. Response rate (36%).

Most patients are channeled into research by the health care professionals treating them. Benefits of taking part were seen as: extra care; increased surveillance; obtaining expert information; and being able to help others. Participants also had criticisms which included lack of information about research findings, problems in making sense of adverse events, insufficient attention to their comfort and 'unscientific' aspects of particular studies.

Participation in clinical research is not entirely altruistic. Patients expected reciprocity in their on-going relationship with the researcher. Therefore to help ensure that patients continue to support clinical research, we suggest that: time should be allowed for providing information; greater attention should be paid to physical comfort; opportunities should be provided for involvement in research design, in the excitement of research and for giving feedback on the findings; and contact between patients taking part in the same study should be facilitated. By investing in the idea of scientific progress through research, some subjects are able to transform their suffering into hope for the future.