RESUMO
PURPOSE: The National Cancer Institute (NCI) issued a 2021 memorandum adopting the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) task force recommendations to broaden clinical study eligibility criteria. They recommended that washout periods be eliminated for most prior cancer therapy and when required, to utilize evidence/rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance. PROCESS: A TACL task force reviewed the consortium's research portfolio, the relevant literature and guidance documents from ASCO-Friends, NCI, and US Food and Drug Administration (FDA) to make expert consensus and evidence-based recommendations for modernizing, broadening and codifying TACL-study washout periods while ensuring consistency with pediatric ethics and federal regulations. TACL's screening log was reviewed to estimate the impact that updated washout periods would have on patient inclusivity and recruitment. RESULTS: Over a 19-year period, 42 patients (14.6% of all screened ineligible (n = 287) patients), were identified as excluded from TACL early-phase studies exclusively due to not meeting washout criteria. An additional six (2.1%) did not meet washout and at least one other exclusion criterion. A new TACL washout guidance document was developed/adopted for use. Where washout criteria were not eliminated, rationale/evidenced-based criteria were established with citation. CONCLUSION: In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale/evidenced-based washout period standards largely following guidance from the NCI/ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence.
RESUMO
Canine parvoviruses (CPVs) are a major cause of morbidity and mortality in dogs. However, surveillance has been largely limited to clinically manifest cases, resulting in a dearth of CPV genomic information on virus type, abundance, and diversity, limiting our understanding of its evolutionary dynamics. We tested the feasibility of using dog feces in poop bags collected from outdoor waste bins as a source for environmental surveillance of CPV. After polymerase chain reaction, long-read sequencing, and bioinformatics, we identified that CPV-2c was present in Arizona, USA, in June 2022 and documented variants with amino acid substitutions 530E and 101K in NS1 and NS2, respectively. Based on publicly available sequence data in GenBank as of January 2023, the CPV genome described here represents the only CPV genome described in the USA from the 2022 season, despite news of CPV outbreak-associated fatalities in dogs in the USA. This highlights the need for more studies that document CPV complete or near complete genomes, as well as experimental studies, to further our understanding of its evolutionary process.