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Understanding How the Perception of Risks and Benefits Influence Cancer Clinical Trial Withdrawal Outcomes

While people with cancer have options to participate in cancer clinical trials (CCTs), it can be challenging when they encounter difficulties enrolling and remaining in the trial. Trial withdrawal, although every participant’s right, can thwart study goals and hamper advancing novel treatments.

December 07, 2022
Connie M. Ulrich, PhD, RN, FAAN, the Lillian S. Brunner Chair in Medical and Surgical Nursing, Professor of Nursing and Professor of Medi... Connie M. Ulrich, PhD, RN, FAAN, the Lillian S. Brunner Chair in Medical and Surgical Nursing, Professor of Nursing and Professor of Medi...
Connie M. Ulrich, PhD, RN, FAAN, the Lillian S. Brunner Chair in Medical and Surgical Nursing, Professor of Nursing and Professor of Medical Ethics and Health Policy at Penn Nursing.

Until now, little attention has focused on what influences retention after participants are enrolled in the trial, especially the role of perceived benefits and burdens. A new investigation from the University of Pennsylvania School of Nursing (Penn Nursing) has examined the association between patients’ perceived benefits and burdens of research participation and CCT retention. It found that patients perceived important benefits from CCT participation, which was associated with trial retention, even among those who also perceived substantial burdens.

“The findings of how perceptions of benefits and burdens were associated with CCT withdrawal outcomes provide novel and foundational evidence of the importance of understanding these perceptions for trial retention,” explains Connie M. Ulrich, PhD, RN, FAAN, Lillian S. Brunner Chair in Medical and Surgical Nursing, Professor of Nursing and Professor of Medical Ethics and Health Policy at Penn Nursing. Ulrich is the lead investigator of the study.

The study found that when perceived benefits were equal to or greater than perceived burdens, participants were less likely to withdraw than those who perceived the burdens to be greater than the benefits. How participants think about benefits and burdens in a research trial may differ from how researchers and IRBs discern the trial’s acceptability.

“Protection of human participants is critical, but more research is needed on how participants perceive benefits, the different types and categories of benefits, and implications of perceived benefits for retention to elucidate the role of benefits compared with the risks and burdens that participants are asked to bear,” says Ulrich.

The results of the study have been published in the article “Association of Perceived Benefit or Burden of Research Participation With Participants’ Withdrawal From Cancer Clinical Trials,” available online on JAMA Network.

Coauthors of the article include: Mary D. Naylor, PhD, RN, FAAN, Marian S. Ware Professor in Gerontology Director of the NewCourtland Center for Transitions and Health, Therese S. Richmond, PhD, RN, FAAN, Andrea B. Laporte Professor of Nursing and Associate Dean for Research & Innovation, and Liming Huang, all of Penn Nursing; Sarah J. Ratcliffe of the University of Virginia; Qiuping Zhou of the George Washington University; Camille Hochheimer of the Colorado School of Public Health; Thomas Gordon of the University of Massachusetts; Kathleen Knafl of the University of North Carolina at Chapel Hill; Marilyn M. Schapira of the Perelman School of Medicine at the University of Pennsylvania and the Veterans Affairs Medical Center; Christine Grady of the National Institutes of Health; and Jun J. Mao of Memorial Sloan Kettering.

Ulrich was supported in part by grant R01CA196131 from the National Cancer Institute of the NIH (NCI/NIH). Ratcliffe was supported in part by grant R01-NR014865 from the NCI/NIH. Richmond was supported in part by grant R01CA196131 from the NCI/NIH. Mao was supported in part by grants P30CA008748 and R01CA240417 from the NCI/NIH.

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