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Type: Peer Reviewed Publications

Peer Review | Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer

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ABSTRACT Randomized controlled trials (RCTs) are the gold standard for evaluation of new medical products. However, RCTs may not always be ethical or feasible. In cases where the investigational product is available outside the trial (e.g., through accelerated approval), patients may fail to enroll in clinical trials or drop out early to take the investigational…

Peer Review | Aligning tumor mutational burden (TMB) quantification across diagnostic platforms: phase II of the Friends of Cancer Research TMB Harmonization Project

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Background Tumor mutational burden (TMB) measurements aid in identifying patients who are likely to benefit from immunotherapy; however, there is empirical variability across panel assays and factors contributing to this variability have not been comprehensively investigated. Identifying sources of variability can help facilitate comparability across different panel assays, which may aid in broader adoption of…

Peer Review | Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO–Friends of Cancer Research Joint Research Statement

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Abstract Purpose: Restrictive clinical trial eligibility criteria (EC) limit the number of patients who can enroll and potentially benefit from protocol-driven, investigational treatment plans and reduce the generalizability of trial results to the broader population. Following publication of expert stakeholder recommendations for broadening EC in 2017, the American Society of Clinical Oncology (ASCO) and Friends…

Peer Review | Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group

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Abstract Purpose: Performance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias. Experimental Design: A multidisciplinary working group of the…

Peer Review | Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO–Friends of Cancer Research Prior Therapies Work Group

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Abstract Purpose: Restrictive eligibility criteria induce differences between clinical trial and “real-world” treatment populations. Restrictions based on prior therapies are common; minimizing them when appropriate may increase patient participation in clinical trials. Experimental Design: A multi-stakeholder working group developed a conceptual framework to guide evaluation of prevailing practices with respect to using prior treatment as…

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group

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Abstract Purpose: In clinical research, eligibility criteria promote patient safety and optimize the evidence generated from clinical trials. However, overly stringent eligibility criteria, including laboratory requirements, may limit enrollment, resulting in delayed trial completion and potentially limiting applicability of trial results to a general practice population. Experimental Design: Starting in 2018, a working group consisting…

Peer Review | Expedited Development Programs at the Food and Drug Administration: Insights and Opportunities

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Timely access to therapies that treat serious illnesses is critical for patients, particularly for those with rare or serious disease types that have no current treatments. Congress and the Food and Drug Administration (FDA) have addressed this by periodically establishing programs designed to expedite different steps associated with the development and review of drugs and…

Peer Review | Establishing guidelines to harmonize tumor mutational burden (TMB): in silico assessment of variation in TMB quantification across diagnostic platforms

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Peer Review | Accelerating the development of innovative cellular therapy products for the treatment of cancer

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Abstract The field of cell therapy is rapidly emerging as a priority area for oncology research and drug development. Currently, two chimeric antigen receptor T-cell therapies are approved by the US Food and Drug Administration and other agencies worldwide for two types of hematologic cancers. To facilitate the development of these therapies for patients with…

Peer Review | An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non–Small-Cell Lung Cancer

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