Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?
Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word "hope" was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research.
Centre for Medical Ethics and Law, University of Stellenbosch Tygerberg, South Africa tinamalan@live.co.za km@sun.ac.za.
Tina
T
Malan
Centre for Medical Ethics and Law, University of Stellenbosch Tygerberg, South Africa.
Keymanthri
K
Moodley
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research / Q000941:ethics*; D032882:Comprehension; D005260:Female; D065026:Hope; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms; D036301:Qualitative Research; D012306:Risk; D018570:Risk Assessment; D013019:South Africa; D011795:Surveys and Questionnaires; D055990:Therapeutic Misconception; D035862:Vulnerable Populations
informed consent; oncology; oncology clinical trials; research ethics; therapeutic misconception