Trial oversight
adverse drug reactions, Cancer
ADVERSE DRUG REACTIONS, CANCER
This trial was designed by the trial study committee and the trial sponsor investigator (Araz Marachelian, NANT Medical Director)—registration number NCT03107988. The trial was designed in collaboration with Pfizer, which provided lorlatinib and funding for the trial. Trial investigators provided input into the trial. Each site’s institutional review board approved the protocol and consent (Children’s Hospital Los Angeles Institutional Review Board; Emory University Institutional Review Board; Children’s Hospital of Philadelphia Institutional Review Board; Cincinnati Children’s Hospital Institutional Review Board; Colorado Multiple Institutional Review Board; Cook Children’s Health Care System Institutional Review Board; Comité de Protection des Personnes Ile-de-France X; Dana-Farber Cancer Institute, Office for Human Research Studies; London City & East Research Ethics Committee; Seattle Children’s Institutional Review Board; SickKids Research Ethics Board; University of Chicago Biological Sciences Division Institutional Review Board; University of California, San Francisco Human Research Protection Program Institutional Review Board; and University of Michigan Medical School Institutional Review Board). The trial was conducted in accordance with the Declaration of Helsinki, International Conference on Harmonization guidelines for Good Clinical Practice and local regulations. Patients or legal guardians provided informed consent, and assent was obtained per institutional guidelines. Participants were not compensated. Each local IRB/IEC (where required by the IRB/IEC) were notified of all serious, unexpected adverse drug reactions involving risk to human patients. Progress reports were also provided to IRBs/IECs. The NANT Consortium independent Data and Safety Monitoring Board monitored the study. The sponsor had full access to the study as it was an open-label study. The sponsor and authors jointly collected and analyzed the data. All authors participated in the writing of the report and had full access to the raw data. The first and corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors vouch for the validity of the trial results and adherence to the protocol.