**Abstract**
**Objective:** The objective of this methodological review is to assess the quality of reporting in early phase dose-finding clinical trials (EPDF trials), identify gaps in the reporting of such trials, and inform the development of an extension of the CONSORT statement for EPDF trials.
**Introduction:** Incomplete, unclear, or inaccurate reporting of the design, conduct, methods and results of EPDF trials can hinder interpretability, reproducibility, and impact on timely clinical development and may lead to erroneous conclusions on safety and efficacy. There currently exists no work that assesses the reporting quality in this specific setting - this review will address the gap by evaluating the quality of published EPDF trials.
**Inclusion criteria:** Peer-reviewed early phase I or I/II dose-finding trial papers where interim treatment dose-decisions have to be undertaken using accumulating trial data to either escalate, de-escalate, stay at the current level or stop a trial early, will be included. It excludes trials that do not include sequential interim dose-decisions and where the aims are not to assess safety or to identify a recommended dosing regimen(s) for further testing.
**Methods:** MEDLINE via PubMed will be searched for articles published in English, from 2011 to 2020. Results will be screened for inclusion. Amongst trials that satisfy the inclusion criteria, we will randomly select 476 dose-finding trials stratified by oncology/non-oncology settings. Data will be extracted in three stages, with a sample of 10% validated by independent reviewers. Data analysis will primarily be descriptive.
**Keywords:** Clinical trials; dose escalation; dose-finding; early phase; phase I.