Related Experiment Video

Updated: Jul 28, 2025

Dosimetry for Cell Irradiation using Orthovoltage 40-300 kV X-Ray Facilities

Dosimetry for Cell Irradiation using Orthovoltage 40-300 kV X-Ray Facilities

Published on: February 20, 2021

Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review

Guillermo Villacampa¹, Dhrusti Patel¹, Haiyan Zheng²

¹Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.

Eclinicalmedicine

|June 1, 2023

Abstract

Background:

The paradigm of early phase dose-finding trials has evolved in recent years. Innovative dose-finding designs and protocols which combine phases I and II are becoming more popular in health research. However, the quality of these trial protocols is unknown due to a lack of specific reporting guidelines. Here, we evaluated the reporting quality of dose-finding trial protocols.

Methods:

We conducted a cross-sectional study of oncology and non-oncology early phase dose-finding trial protocols posted on ClinicalTrials.gov in 2017-2023. A checklist of items comprising: 1) the original 33-items from the SPIRIT 2013 Statement and 2) additional items unique to dose-finding trials were used to assess reporting quality. The primary endpoint was the overall proportion of adequately reported items. This study was registered with PROSPERO (no: CRD42022314572).

Finding:

A total of 106 trial protocols were included in the study with the rule-based 3 + 3 being the most used trial design (39.6%). Eleven model-based and model-assisted designs were identified in oncology trials only (11/58, 19.0%). The overall proportion of adequately reported items was 65.1% (95%CI: 63.9-66.3%). However, the reporting quality of each individual item varied substantially (range 9.4%-100%). Oncology study protocols showed lower reporting quality than non-oncology. In the multivariable analysis, trials with larger sample sizes and industry funding were associated with higher proportions of adequately reported items (all p-values <0.05).

Interpretation:

The overall reporting quality of early phase dose-finding trial protocols is suboptimal (65.1%). There is a need for improved completeness and transparency in early phase dose-finding trial protocols to facilitate rigorous trial conduct, reproducibility and external review.

Funding:

None.

Keywords:

Dose-escalation Dose-finding Early phase trials Oncology Protocols SPIRIT

More Related Videos

Irradiator Commissioning and Dosimetry for Assessment of LQ α and β Parameters, Radiation Dosing Schema, and in vivo Dose Deposition

Irradiator Commissioning and Dosimetry for Assessment of LQ α and β Parameters, Radiation Dosing Schema, and in vivo Dose Deposition

Published on: March 11, 2021

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

Published on: June 6, 2020

Related Concept Videos

Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

Types of Reports III: Telephone and Verbal Reports

Types of Reports III: Telephone and Verbal Reports

Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders

Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

Articles linked to this work by shared authors, journal, and citation graph.

Rationale and trial design of RIBOLARIS: A phase II trial of neoadjuvant and adjuvant ribociclib plus endocrine therapy for clinically high-risk HR+/HER2-negative breast cancer.

Therapeutic advances in medical oncology·2026

Platinum Rechallenge in Platinum-Resistant Ovarian Cancer: Clinical Outcomes and the Impact of BRCA Status.

Cancers·2026

Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results.

NPJ breast cancer·2026

A Phase I trial of the anti-IL23 monoclonal antibody tildrakizumab, in combination with abiraterone acetate, for the treatment of metastatic castration-resistant prostate cancer.

Investigational new drugs·2026

PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.

Statistical methods in medical research·2026

Phase I Trial of Ipatasertib plus Atezolizumab Enhances PI3K/AKT Pathway Immune Responses in Solid Tumors and Refractory Glioblastoma.

Clinical cancer research : an official journal of the American Association for Cancer Research·2026

See all related articles