Pediatric Trials for Cancer Therapies with Targets Potentially Relevant to Pediatric Cancers.

08:00 EDT 29th October 2019 | BioPortfolio

Summary of "Pediatric Trials for Cancer Therapies with Targets Potentially Relevant to Pediatric Cancers."

The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the FDA to require pediatric studies for new cancer drugs that have a molecular target relevant to the growth or progression of a pediatric cancer. To assess the possible scope of this new policy, we examined all 78 adult cancer drugs approved by the FDA from 2007-2017. Only 17 (21.8%) drugs received any pediatric labeling information. Based on the FDA's Pediatric Molecular Target List, we found that the RACE Act could have increased the proportion of cancer drugs potentially subject to pediatric study requirements from 0% to 78.2%. However, the actual impact of the Act will depend on how often regulators require pediatric trials and on timely completion of such trials.


Journal Details

This article was published in the following journal.

Name: Journal of the National Cancer Institute
ISSN: 1460-2105


DeepDyve research library

PubMed Articles [31299 Associated PubMed Articles listed on BioPortfolio]

Novel therapy for pediatric and adolescent kidney cancer.

Pediatric and adolescent renal tumors account for approximately 7% of all new cancer diagnoses in the USA each year. The prognosis and treatment are varied based on factors including the underlying hi...

Targeted therapy clinical trials in ovarian cancer: improved outcomes by gene mutation screening.

Epithelial ovarian cancer is the most common and leading cause of death for gynaecologic cancer in the western world. Current standard treatments with limited selection of chemotherapies cannot meet p...

The use of biologic therapies for the management of pediatric asthma.

With better understanding of the role of type 2 inflammation in allergic asthma, there has been progress made in the development of new biologic therapies targeting these specific pathways. This revie...

Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research.

Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient-reported outcome (PRO...

Single-Arm Phase II Trials of Combination Therapies: A Review of the CTEP Experience 2008-2017.

Designing and interpreting single-arm phase II trials of combinations of agents is challenging because it can be difficult based on historical data to identify levels of activity for which the combina...

Clinical Trials [20232 Associated Clinical Trials listed on BioPortfolio]

Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy

New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.

Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases

The objective of our study will be to analyze the interplay between particular VDR variants and its ligand in cells obtained from intervertebral disc and cartilage endplate and their actio...

Patient Perceptions and Willingness to Enroll in Clinical Trials

The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be...

CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)

Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate cancer seems to have an impact on the cardio-vascular system. This study investigates ...

Stemcells for Radiation Induced Xerostomia

The current study aims to assess the safety and feasibility of the injection of autologous adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia in he...

Medical and Biotech [MESH] Definitions

Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies. (Campbell's Psychiatric Dictionary, 9th ed.)

Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial.

Treatments which are undergoing clinical trials or for which there is insufficient evidence to determine their effects on health outcomes; coverage for such treatments is often denied by health insurers.

These evidence-based therapies to reduce symptoms associated with treatment of cancer.

Therapies using arts or directed at the senses.

Quick Search

DeepDyve research library

Relevant Topics

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Searches Linking to this Article