To date there has been little research on the experience of participating in a clinical trial. This research sought to describe the experiences of those involved in IllV clinical trials in Australia. Patients, doctors, nurses and pharmaceutical company staff involved in mv clinical trials participated in this thesis. Patients in three clinical trials from 1994-1998 took part in questionnaires and interviews to identify why they enrolled into the trials, who influenced their decision and to

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... ibe their experience during participation. Doctors, nurses and pharmaceutical company staff participated in interviews that aimed to document the issues for professionals working in this area. The researcher is a clinical trial LIBRARY SUMMARY To date there has been little research on the experience of participating in a clinical trial. This research sought to describe the experiences of those involved in HIV clinical trials in Australia. Patients, doctors, nurses and pharmaceutical company staff involved in IDV clinical trials participated in this thesis. Patients in three clinical trials from 1994-1998 took part in questionnaires and interviews to identify why they enrolled into the trials, who influenced their decision and to describe their experience during participation. Doctors, nurses and pharmaceutical company staff participated in interviews that aimed to document the issues for professionals working in this area. The researcher is a clinical trial nurse and her experiences as a participant/observer are reported. Patients enter clinical trials predominantly to access to new therapy and to help others in their situation. Most patients experience a positive benefit in improved mood, access to information, support from clinical trial staff and increased numbers of medical check-ups whilst on study. Their major concerns are side-effects of medication, flexibility of trial visits, confidentiality and lack of feedback of trial results. Doctors are enthusiastic about including clinical trials within their role as it is intellectually challenging and provides access to new therapies for their patients. The trials may result in other rewards such as publications and kudos. However there is a conflict between their role as a clinician and investigator, specifically in balancing the needs of patients and the requirements of a trial. Nurses have a multifaceted role within clinical trials, which includes patient advocacy, education, counseling as well as coordinating study requirements. This is a role they enjoy but they have concerns regarding patient consent, terminating their relationship with a patient at the end of the study and lack of appreciation for their contribution. Pharmaceutical company staff found HIV a very challenging area and believed that IDV activists have altered companies' relationships with patients and have emphasised that the patients rather than prescribers are the consumers of pharmaceutical products. Experiences in HN clinical trials can be challenging for those involved but may also be worthwhile and fulfilling. This is largely determined by the perceived benefits of participation but is not dependent upon the efficacy ofthe drug being tested.