Study oversight
Cancer
CANCER
The study was cosponsored by The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust and approved by a Research Ethics Committee (16/SC/0271). The study was conducted according to the approved protocol and its amendments, supplementary guidance and manuals supplied by the cosponsors and in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, the Research Governance Framework for Health and Social Care and the principles of Good Clinical Practice. All participants gave written informed consent prior to registration for ctDNA testing, and again prior to treatment cohort entry. Safety and efficacy data were reviewed regularly by an Independent Data Monitoring Committee (IDMC). Trial oversight was provided by an independent Trial Steering Committee (TSC). This study is registered with ClinicalTrials.gov, NCT03182634; the European Clinical Trials database, EudraCT2015–003735–36; and the ISRCTN registry, ISRCTN16945804. The funders of the study (Cancer Research UK, AstraZeneca, Guardant Health, and Bio-Rad) had no role in study design, data collection, data analysis, data interpretation, or writing of the report. AstraZeneca reviewed the final version of the report but had no role in the decision to submit the manuscript for publication. The corresponding author had full access to all of the data and the final responsibility to submit for publication.