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Peer Review | The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies

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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)…

Peer Review | Comparing Findings From a Friends of Cancer Research Exploratory Analysis of Real-World End Points With the Cancer Analysis System in England

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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…

Peer Review | Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets.

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Background:Response Evaluation Criteria in Solid Tumors (RECIST) based response rate (RR) is used for efficacy evaluation in clinical trials and relies on imaging data collected at specified timepoints for uniform assessment. In routine clinical practice, the method and timing of response assessment can vary, and imaging data from electronic health records (EHR) and other real…

Peer Review | A Study Design to Harmonize Patient-Reported Outcomes Across Data Sets

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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…

Peer Review | Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials

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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…

Peer Review | Changes in Circulating Tumor DNA Reflect Clinical Benefit Across Multiple Studies of Patients With Non–Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors

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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…

Peer Review | Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies

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The breakthrough therapy designation (BTD) process was created to expedite clinical development timelines for drugs intended to treat serious conditions and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies. This analysis demonstrates that BTD is a valuable tool for expediting approval of promising therapies in oncology. By comparing drugs indicated…

Peer Review | Abstract 1023: Evaluating the impact of the RACE act: An interim analysis

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Abstract Recent approvals of novel therapeutics, including targeted small-molecules and immunotherapies, have significantly impacted cancer care. However, these advancements have not easily translated to new treatment options and approvals for pediatric cancer patients. The Research to Accelerate Cures and Equity (RACE) Act was signed into law in 2017 to accelerate the availability of drugs for…

Peer Review | Homologous Recombination Deficiency: Concepts, Definitions, and Assays

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Abstract Background Homologous recombination deficiency (HRD) is a phenotype that is characterized by the inability of a cell to effectively repair DNA double-strand breaks using the homologous recombination repair (HRR) pathway. Loss-of-function genes involved in this pathway can sensitize tumors to poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors and platinum-based chemotherapy, which target the destruction of…

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…

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