Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain

Eric S Swirsky; Andrew D Boyd; Carol Gu; Larisa A Burke; Ardith Z Doorenbos; Miriam O Ezenwa; Mitchell R Knisely; Jonathan W Leigh; Hongjin Li; Molly W Mandernach; Robert E Molokie; Crystal L Patil; Alana D Steffen; Nirmish Shah; Victoria A deMartelly; Karen L Staman; Judith M Schlaeger

doi:10.1016/j.conctc.2023.101218

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain

Contemp Clin Trials Commun. 2023 Oct 5:36:101218. doi: 10.1016/j.conctc.2023.101218. eCollection 2023 Dec.

Authors

Eric S Swirsky¹, Andrew D Boyd¹, Carol Gu¹, Larisa A Burke¹, Ardith Z Doorenbos¹, Miriam O Ezenwa², Mitchell R Knisely³, Jonathan W Leigh¹, Hongjin Li¹, Molly W Mandernach², Robert E Molokie¹, Crystal L Patil¹, Alana D Steffen¹, Nirmish Shah³, Victoria A deMartelly¹, Karen L Staman⁴, Judith M Schlaeger¹

Affiliations

¹ University of Illinois Chicago, Chicago, IL, USA.
² University of Florida, Gainesville, FL, USA.
³ Duke University, Durham, NC, USA.
⁴ Duke Clinical Research Institute, Durham, NC, USA.

Abstract

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Keywords: Depression; Patient-reported outcomes; Pragmatic trial; Research ethics; Suicidal ideation; Suicidal monitoring.