Type: Peer Reviewed Publications

Background Diagnostic tests, including US Food and Drug Administration (FDA)-approved tests and laboratory-developed tests, are frequently used to guide care for patients with cancer, and, recently, have been the subject of several policy discussions and insurance coverage determinations. As the use of diagnostic testing has evolved, stakeholders have raised questions about the lack of standardized…

Randomized controlled trials (RCTs) evaluate the safety and efficacy of medical products in specific patient populations under rigorously controlled conditions. While adherence to structured protocols, use of restrictive eligibility criteria, and patient randomization maximize the internal validity of RCT results, eligibility and protocol-directed care may reduce the relevancy of study results for broader patient populations…

The 21st Century Cures Act was enacted in 2016, to evaluate the health policy goals of trial design modernization and use of real-world evidence (RWE) creating numerous synergistic efforts.1 These efforts aim to further understand ways in which RWE may complement or supplement randomized controlled trial data for regulatory purposes.2–6 Evaluating applied examples of real-world data (RWD)…

Randomized controlled trials (RCTs) are the gold standard for assessing safety and efficacy of drugs; however, RCTs have limitations such as controlled settings, selective patient populations, and short-term study outcomes that might not be generalizable to heterogenous real-world populations and settings.1–3 There is a need to understand the effectiveness of medical interventions in representative real-world populations…

Background: The onset of the COVID-19 pandemic resulted in major disruptions in enrollment and conduct of cancer clinical trials. In response, regulators allowed modifications to traditional trial processes to enable clinical research and care to continue. The American Society of Clinical Oncology and Friends of Cancer Research established a task force to evaluate how sponsors…

ABSTRACT ChooseTop of pageAbstract <<INTRODUCTIONCHALLENGES TO ePRO DATA S…A FRAMEWORK TO HARMONIZE …REFERENCES PURPOSE Using patient-reported outcomes (PROs) provides important insights from the patient’s perspective and can be valuable to monitor and manage treatment-related adverse events during cancer treatment. Additionally, the digital administration of PROs (electronic PROs [ePROs]) provides real-time updates to clinical care teams…

Abstract As cancer immunotherapies continue to expand across all areas of oncology, it is imperative to establish a standardized approach for defining and capturing clinically important toxicities, such as cytokine release syndrome (CRS). In this paper, we provide considerations for categorizing the variety of adverse events that may accompany CRS and for recognizing that presentations…

PURPOSE As immune checkpoint inhibitors (ICI) become increasingly used in frontline settings, identifying early indicators of response is needed. Recent studies suggest a role for circulating tumor DNA (ctDNA) in monitoring response to ICI, but uncertainty exists in the generalizability of these studies. Here, the role of ctDNA for monitoring response to ICI is assessed…