Your browser doesn't support javascript.
Actions of a national oncology group to manage the impact of the COVID-19 pandemic
Clinical Trials ; 18(SUPPL 5):80-81, 2021.
Article in English | EMBASE | ID: covidwho-1582552
ABSTRACT
SWOG Cancer Research Network, part of the National Cancer Institute's National Clinical Trials Network and the National Cancer Institute Community Oncology Research Program, designs and conducts clinical trials to improve the lives of people with cancer. Trial designs are Phase 2, 2/3 and 3 as well as observational cohorts and focus on cancer treatment or on supportive care, symptom management, cancer care delivery, or cancer control. Approximately 4000 patients are put on SWOG trials annually by study sites across all 50 states as well as by international sites;currently, there are 90 active trials. The COVID-19 pandemic forced SWOG to pivot to address the large range of issues facing the study sites that put patients on its trials, as well as required the group to track the impact of the pandemic on its trials. Information was flowing from a variety of sources and we needed to quickly respond, as well as efficiently distribute the information to study sites, who themselves were burdened with pandemic-related staffing and process issues. National Cancer Institute guidance to sites addressed concerns regarding patient safety and minimizing patient risk. Procedures for obtaining informed consent remotely, the distribution of study drug, and the use of telehealth visits were among the issues addressed. SWOG provided protocol-specific guidance regarding timing of specified activities including allowable registration windows, timing of labs, and collection of specimens and patient-reported outcomes. SWOG created new reports to monitor accrual, developed, and deployed a form to collect National Cancer Institutemandated COVID-specific data, provided study sites with information on the specimen repositories ability to receive and process biological trial samples, as well as a prioritized, study-specific list of specimen requirements. Other changes included a switch to remote Quality Assurance audits and adjustments to how sites were monitored regarding submission of data and specimens. New internal data management processes for the remote work environment were implemented. Because of the volume of information, SWOG rapidly launched a clearinghouse on SWOG's website (swog.org) to centrally compile real-time COVID-19 resources, news, and information, including the general guidance documents from SWOG, the National Cancer Institute, its Central institutional review board, and the Food and Drug Administration. Protocol-specific memoranda were issued for 22 SWOG trials. The semi-annual SWOG Group Meeting scheduled for April 2020 was switched to a remote meeting as were the subsequent two meetings and other trainings and seminars. Even with all the changes, 14 new trials were activated in 2020 and 107 journal articles published. Accrual was impacted differentially by disease area, study phase, and trial type. SWOG staff across multiple offices worked together to modify and adjust processes so that site staff could continue to offer the highest quality clinical trials and care for cancer patients amid a public health emergency. In our presentation, we will discuss lessons learned and the impact of the pandemic on the future of clinical trials.
Keywords

Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies Language: English Journal: Clinical Trials Year: 2021 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies Language: English Journal: Clinical Trials Year: 2021 Document Type: Article