Goli Samimi, Sarah M Temkin, Carol J Weil, Paul K Han, Elyse LeeVan, Wendy S Rubinstein, Tessa Swigart, Sarah Caban, Katherine Dent, Lori M Minasian
JNCI Cancer Spectr . 2024 Sep 12:pkae084. doi: 10.1093/jncics/pkae084. Online ahead of print.
Background: The National Cancer Institute Cancer Screening Research Network is launching a pilot study ("Vanguard") to determine feasibility of successful completion of a clinical trial of multi-cancer detection (MCD) tests. This focus group study reports perceptions of primary care physicians (PCP) and laypersons of different clinical trial designs, and willingness to participate in an MCD clinical trial.
Methods: We undertook 14 focus groups with 88 laypersons and six focus groups with 45 PCPs. Participants were shown graphics of clinical trial designs and asked for their reactions. Focus group recordings were transcribed verbatim and thematic analysis of the transcripts were conducted to identify emergent themes.
Results: PCP and laypersons participants recognized the importance of conducting clinical trials to determine the clinical utility of MCD tests. PCPs expressed reluctance to participate in trials due to workload burden and laypersons expressed hesitancy about enrolling in the control group. Both PCPs and laypersons expressed concern about a study design in which MCD test results would not be returned to the control group ("Intended Effect"), but they respectively indicated a willingness to refer patients to, or participate in, an MCD test clinical trial given transparent and clear communication on collection and use of biospecimens and data, particularly if an MCD test would eventually be run and results eventually returned.
Conclusion: This study yielded important insights to guide trial design in planning prospective evaluation of MCD testing. Maintaining transparency and trust while possibly withholding MCD test results to maximize trial feasibility and efficiency, is of particular concern.