Additional file 5 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 5. Further details on the statistical analysis plan

Additional file 1 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 1. Composition of the DEFINE Executive Committee and Independent Expert Panel

Additional file 10 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 10. List of candidate items to be discussed at the DEFINE Consensus meeting

Additional file 8 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 8. Delphi survey participants demographics and harmonisation of roles: Tables A8-1 – A8-2. Table A8-1. Demographics of Delphi survey participants. Table A8-2. Harmonisation of participants’ defined roles

Additional file 2 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 2. CONSORT and SPIRIT DEFINE Literature review: Figures A2-1 – A2-2, Tables A2-1. Figure A2-1. PRISMA 2020 flow diagram for the CONSORT-DEFINE literature search and review. Figure A2-2. PRISMA flow diagram for the SPIRIT-DEFINE literature search and review. Table A2-1. Terms used in the PubMed searches and the number of hits from each search terms for SPIRIT-DEFINE

Additional file 6 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 6. SPIRIT-DEFINE and CONSORT-DEFINE items generation for Delphi survey: Table A6-1. Table A6-1. References supporting the proposed candidate items in the DEFINE Delphi survey

Additional file 11 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 11. Qualitative analysis. Table A11-1; Figure A11-1. Table A11-1. Themes and codes identified in the general comments received in Delphi survey. Figure A11-1. Tree diagram of the comments received per theme

Additional file 4 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 4. Delphi Survey key stakeholder groups and methods of access

Additional file 3 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 3. Organisations contacted for protocol templates or guidelines and responses

Additional file 7 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Additional file 7. Toolkit for Lay Summary of EPDF Trial Results