To ensure that we maintained a patient-centered approach to the design and development of this study, we required the opportunity for open dialogue between the multidisciplinary and international SAFETY Steering Committee and study team, along with patient / caregiver representatives and other key stakeholders. To facilitate their interaction and collaboration, we held an in-person Protocol Development Meeting in Toronto, ON, Canada in May 2018. Meeting attendees represented expertise in orthopaedic oncology, medical oncology, radiology, clinical epidemiology and statistics, and represented Canada, India, Spain, the United Kingdom, and the United States. Two sarcoma patient representatives were also present. An independent meeting facilitator moderated the meeting to ensure that the discussion remained neutral, productive and timely, and to ensure that the voices of all meeting attendees were heard. At this meeting, we made critical decisions with respect to the study protocol, including: A) study design; B) primary and secondary outcomes; C) patient eligibility; D) follow-up timeframe; E) methods to protect against bias; F) randomization stratification; and G) further patient engagement. We also had the opportunity to discuss several issues that may compromise the study’s success and strategize ways to manage these challenges, such as: I) acceptable surveillance schedules that account for differences in international standards of clinical practice; II) possible ethical concerns; III) patient compliance; IV) local implementation and procedural variation; V) competing studies; and VI) funding opportunities.
Safety