Benefits and burdens of participation in a longitudinal clinical trial.
SYSTEMATIC DATA ON THE IMPACT THAT longitudinal clinical trials have on patient participants are needed to ensure that all the risks and potential benefits of participating in clinical research are properly evaluated and disclosed. Recognizing the lack of systematic data on this topic, we surveyed 582 individuals from Argentina, Brazil, and Thailand who were participating in the ESPRIT study, a Phase III randomized trial of interleukin-2 in HIV disease. Respondents were asked about the benefits and burdens of participating in ESPRIT using a self-administered survey. We found that 91% of respondents in the IL-2 treatment arm and 79% in the no IL-2 control arm reported medical benefits from their participation. In addition, 68% in the IL-2 treatment arm and 60% of the no IL-2 controls reported non-medical benefits. Thirteen percent of the IL-2 respondents and 5% of the non-IL2 respondents reported problems with their jobs due to study participation. Given that respondents, including those in the control arm, reported medical and non-medical benefits and burdens from their research participation, investigators and review committees should be aware of and respond to the potential for research participants to experience benefits and burdens that are unrelated to the intervention being tested.
Lazovski
Jaime
J
Argentina Sites Coordinating Center for the ESPRIT Study. jaimelazovski@hotmail.com
Losso
Marcelo
M
Krohmal
Benjamin
B
Emanuel
Ezekiel J
EJ
Grady
Christine
C
Wendler
David
D
D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D003625:Data Collection; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D015337:Multicenter Studies as Topic; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic / Q000523:psychology; D018570:Risk Assessment; D055815:Young Adult
D044966:Anti-Retroviral Agents; D007376:Interleukin-2