Evidence Threshold for a Precision Medicine Test that Predicts Optimal Response to a Biologic Agent in Patients With Psoriasis: A Consensus Panel.

Precision medicine approaches are receiving increased attention in dermatology, including inflammatory skin diseases. In psoriasis, a precision medicine treatment paradigm could temper the rapid increase in pharmacy costs that have resulted from a tremendous expansion in the number of available biologic drug options. However, without a clear and agreed upon proof of clinical utility in a real-world setting, costly new pharmacotherapies are often burdened with barriers to coverage by payers and ultimately, routine patient care. This panel was assembled to discuss the evidence threshold required to demonstrate the clinical utility of a precision medicine diagnostic that predicts the biologic therapeutic class for treating psoriasis patients. The panel reviewed clinical utility study designs and economic impact study designs aimed at delineating net savings and waste reduction. A psoriasis biologic precision medicine test could optimize pharmacotherapy management of psoriasis patients. The consensus opinion of this panel was that positive results from the study described here would prove the clinical utility of this precision medicine test. J Drugs Dermatol. 2022;21(6):630-636. doi:10.36849/JDD.6864.

Oncology comparative effectiveness research: a multistakeholder perspective on principles for conduct and reporting.

Comparative effectiveness research (CER) can assist patients, clinicians, purchasers, and policy makers in making more informed decisions that will improve cancer care and outcomes. Despite its promise, the factors that distinguish CER from other types of evidence remain mysterious to many oncologists. One concern is whether CER studies will improve decision making in oncology or only add to the massive amount of research information that decision makers must sift through as part of their professional responsibilities. In this report, we highlight several issues that distinguish CER from the most common way evidence is generated for cancer therapy-phase I-III clinical trials. To identify the issues that are most relevant to busy decision makers, we assembled a panel of active professionals with a wide range of roles in cancer care delivery. This panel identified five themes that they considered most important for CER in oncology, as well as fundamental threats to the validity of individual CER studies-threats they termed the "kiss of death" for their applicability to practice. In discussing these concepts, we also touched upon the notion of whether cancer is special among health issues with regard to how evidence is generated and used.