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What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?

ABSTRACT: PURPOSE::Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient's contribution to and potential benefit from a clinical trial. METHODS::To improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices. RESULTS::Among the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality. CONCLUSION::Implementing these recommendations at the National Cancer Institute's Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care.

SUBMITTER: Ferry-Galow KV

PROVIDER: S-EPMC6237512 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?

Ferry-Galow Katherine V KV Datta Vivekananda V Makhlouf Hala R HR Wright John J Wood Bradford J BJ Levy Elliot E Pisano Etta D ED Tam Alda L AL Lee Susanna I SI Mahmood Umar U Rubinstein Lawrence V LV Doroshow James H JH Chen Alice P AP

Journal of oncology practice 20181004

<h4>Purpose:</h4>Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to ...[more]

PMID: 30285529

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Project description:Importance:Quality of life (QoL) is an important consideration in cancer medicine, especially because drugs are becoming more costly and may only result in modest gains in overall survival. However, there has been no descriptive analysis for the points at which QoL is measured in cancer trials. Objective:To estimate the prevalence of studies that measure QoL at different points and see how many studies measure QoL for the entirety of a patient's life. Design, Setting, and Participants:This cross-sectional analysis includes all articles on oncology clinical trials in the 3 highest-impact oncology journals, published between July 2015 and June 2018, that reported QoL outcomes. Main Outcomes and Measures:Data were abstracted on when QoL was assessed and the characteristics of these studies. Results:For all 149 studies that met inclusion criteria, QoL assessment was high during treatment (104 articles [69.8%]), during follow-up (81 articles [54.4%]), and after the end of the intervention (68 articles [45.6%]). In 5 of the 149 studies (3.4%), QoL was assessed until death, including in only 1 of the 74 studies on metastatic or incurable cancers. Among these 5 studies, only 1 (20%) used a drug intervention, 1 (20%) used a behavioral intervention, and 2 (40%) used a radiation intervention; only 1 of 5 was in the metastatic setting. The number of studies that reported a positive QoL outcome (ie, QoL outcome was more favorable in the intervention group than in the control group) was between 42 of 81 articles (51.9%) and 16 of 28 articles (57.1%) for most QoL assessment points but only 1 of 5 articles (20%) for studies measuring QoL until death. Conclusions and Relevance:This study found that most clinical trials assessed QoL during the treatment or intervention and often during a given amount of follow-up but infrequently assessed QoL on disease progression and rarely followed QoL until the end of the patient's life. Most studies reporting QoL until the end of life reported worse QoL outcomes for the intervention group than the control group. Future research and policy recommendations should consider not just short-term QoL outcomes but QoL outcomes throughout the patient's cancer care.

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What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?

Publications

What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?

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