TY - JOUR
T1 - Harms, benefits, and the nature of interventions in pragmatic clinical trials
AU - Ali, Joseph
AU - Andrews, Joseph E.
AU - Somkin, Carol P.
AU - Rabinovich, C. Egla
N1 - Funding Information:
This work is supported by the National Institutes of Health (NIH) Common Fund, through a cooperative agreement (U54 AT007748) from the Office of Strategic Coordination within the Office of the NIH Director. Additional support was provided by the Patient-Centered Outcomes Research Institute (PCORI) Award for the development of the National Patient-Centered Clinical Research Network (PCORnet).
Publisher Copyright:
© 2015 The Society for Clinical Trials.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.
AB - To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.
KW - Research ethics
KW - benefits
KW - bioethics
KW - harms
KW - pragmatic clinical trials
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U2 - 10.1177/1740774515597686
DO - 10.1177/1740774515597686
M3 - Article
C2 - 26374680
AN - SCOPUS:84942878641
SN - 1740-7745
VL - 12
SP - 467
EP - 475
JO - Clinical Trials
JF - Clinical Trials
IS - 5
ER -