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

Additional file 9. Perception of proposed items and sensitivity analysis: Tables A9-1 – A9-3, Figures A9-1 – A9-13. Table A9-1. Summary of categorical and numerical ratings at Round One and 2. Figure A9-1. Percentage of participants changing their numerical scores at Round Two. Figure A9-2. Percentage of participants changing their categorical scores at Round Two. Table A9-2. Number of participants changing their ratings between Round One and Round Two. Table A9-3. Frequency and percentage of perfect agreement. Figure A9-3. Stacked bar plots of candidate item [17 SPIRIT-DEFINE] “Planned dosing regimens presented as a diagram or table, where applicable” by stakeholders. Figure A9-4. Stacked bar plots of candidate item [18 CONSORT-DEFINE] “Planned and delivered dosing regimens presented as a diagram or table, where applicable” by stakeholders. Figure A9-5. Stacked bar plots of candidate item [48 SPIRIT-DEFINE] “Statistical methods for additional analyses” by stakeholders. Figure A9-6. Stacked bar plots of candidate item [69 CONSORT-DEFINE] “Specify if and when results were reported whilst the trial was still ongoing” by stakeholders. Figure A9-7. Stacked bar plots of candidate item [70 SPIRIT-DEFINE] “Where the full trial protocol or the redacted version, with amendments, can be accessed” by stakeholders. Figure A9-8. Stacked bar plots of candidate item [17 SPIRIT-DEFINE] “Planned dosing regimens presented as a diagram or table, where applicable” by Continent. Figure A9-9. Stacked bar plots of candidate item [18 CONSORT-DEFINE] “Planned and delivered dosing regimens presented as a diagram or table, where applicable” by Continent. Figure A9-10. Stacked bar plots of candidate item [48 SPIRIT-DEFINE] “Statistical methods for additional analyses” by Continent. Figure A9-11. Stacked bar plots of candidate item [69 CONSORT-DEFINE] “Specify if and when results were reported whilst the trial was still ongoing” by Continent. Figure A9-12. Stacked bar plots of candidate item [70 SPIRIT-DEFINE] “Where the full trial protocol or the redacted version, with amendments, can be accessed” by Continent. Figure A9-13. Stacked bar plots of candidate item [5 SPIRIT-DEFINE] “Summary of findings from existing correlative biomarker, correlative and associated studies to support planned biomarker sub-study” by Continent

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

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