About Careers MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

Kids Wait 6.5 Years More Than Adults to Access New Cancer Drugs

by Ramya Rachamanti on May 22, 2019 at 5:15 PM
Font : A-A+

Kids Wait 6.5 Years More Than Adults to Access New Cancer Drugs

U.S. Food and Drug Administration (FDA) approved cancer drugs took around 6.5 years to go from the first clinical trial in adults to the first trial in children, according to a study done at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center, published in the European Journal of Cancer.

"Despite knowing that these agents are effective anticancer drugs, it's taking too long to even start studying these therapies in children," says Steven G. DuBois, MD, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, corresponding author on the study. "As a doctor taking care of young cancer patients, this is tremendously frustrating. If I were a parent of a child with cancer, I wouldn't stand for this."

Advertisement


The team at Dana-Farber/Boston Children's conducted a systematic analysis of the time from first-in-human trials to first-in-child trials of agents first approved by the FDA for any oncology indication from 1997 to 2017. The investigators utilized clinical trials registry data, published literature and oncology abstracts to identify relevant trials and start dates.

Delayed pediatric trials

In that timeframe, 126 drugs received initial FDA approval for an oncology indication. After excluding hormonal modulators (not relevant to children's cancers), 117 agents remained for analysis. Fifteen of 117 drugs (12.8%) had not yet had a pediatric trial, while 6 of 117 drugs (5.1%) included children in the initial FDA approval.
Advertisement

The data showed a median 6.5-year lag between first-in-human and first-in-child clinical trials, with a range of 0 to 27.7 years.

"Some may argue that this lag is appropriate to ensure safety of a vulnerable pediatric population and to only study agents in children that are on a path to FDA approval, based upon activity in adults with cancer," says DuBois. "Others may argue that this lag is too long for children with life-threatening diseases and that some agents that fail in adult indications may nevertheless prove to be important drugs for pediatric indications."

In the U.S., the recent RACE for Children Act strengthens the requirement that new cancer therapies with potential biological relevance to pediatric cancers be evaluated in children. This study can serve as a benchmark as this new policy is enacted, says DuBois



Source: Eurekalert
Advertisement

Advertisement

Recommended Reading

Latest Drug News

 Understanding Why Aspirin is a Magic Drug for Inflammation
New discoveries about aspirin's interplay between messenger molecules that are crucial in the inflammatory proves again that it is a powerful anti-inflammatory drug.
Is Fomepizole the Key to Overcoming Antibiotic-Resistant Pneumonia?
The new drug target sheds insights into strategies to fight drug-resistant S. pneumoniae, stated research.
 Combination Therapy Benefits Septic Shock Patients
The effectiveness of adding fludrocortisone to hydrocortisone vs hydrocortisone alone among patients with septic shock was analyzed using target trial emulation.
Are Painkillers Safe for Back Pain?
Safety and effectiveness of commonly used painkillers (analgesics) for short-term relief of low back pain remain uncertain.
 India's First Urinary Incontinence Drug Launched
India's First Urinary Incontinence Drug Fesobig may offer Affordable treatment for Overactive Bladder (OAB), a widely prevalent problem among Indian men and women.
View All
open close
CONSULT ONLINE WITH A DOCTOR

×

Kids Wait 6.5 Years More Than Adults to Access New Cancer Drugs Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests