Related Experiment Video
Updated: Jun 12, 2026
07:48
Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Informed consent for pediatric phase 1 cancer trials: physicians' perspectives
Tsiao Yi Yap1, Amy D Yamokoski, Sabahat Hizlan
1Department of Pediatric Hematology/Oncology, Children's Hospital, Cleveland Clinic, Cleveland, Ohio, USA.
Cancer
|June 22, 2010
Summary
Pediatric oncologists prioritize informing families about phase 1 cancer trials. They aim to present options without undue influence, though suggestions exist for improving the informed consent process.
Area of Science:
- Pediatric Oncology
- Clinical Trials
- Bioethics
Background:
- Informed consent is crucial for pediatric phase 1 cancer trials.
- Gathering pediatric oncologists' perspectives on informed consent is essential for improvement.
Purpose of the Study:
- To collect pediatric oncologists' opinions on the informed consent process (ICP) in pediatric phase 1 cancer trials.
- To identify areas for improvement in the ICP for pediatric oncology research.
Main Methods:
- A questionnaire was distributed to 146 pediatric oncologists across 6 institutions.
- A response rate of 71% (103 completed surveys) was achieved.
Main Results:
- Physicians view informing families as the primary goal of the ICP.
- Most physicians (64%) describe trials neutrally; gender and training influenced approaches.
- 63 suggestions were provided for enhancing the ICP, focusing on documents, training, and communication tools.
Conclusions:
- Pediatric oncologists often present phase 1 trials as options, avoiding strong recommendations.
- Concerns exist regarding parental comprehension of complex trial information.
- Improvements in the ICP are needed, requiring further research and education.
Related Concept Videos
01:27Nurses' Legal Responsibilities I
In healthcare, informed consent is a crucial process that involves thoroughly communicating medical treatment options to patients, including benefits, risks, potential side effects, and alternatives. This process enables patients to make well-informed decisions about their care, ensuring they understand the implications of their choices before consenting to or refusing treatment.
The legal responsibilities of a nurse regarding informed consent include the following:
The legal responsibilities of a nurse regarding informed consent include the following:
01:27Nursing Ethical Principles II
Ethical principles are essential in guiding nurses to fulfill their responsibilities, focusing on the quality of nursing care and decision-making. These principles, including autonomy, beneficence, non-maleficence, justice, and fidelity, shape the ethical framework within healthcare settings.
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's cancer...
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's cancer...
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
01:11Clinical 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...
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses a challenge in...