The clinical trials conducted on children’s for the research and development of drugs or formation of new drugs are called as pediatric clinical trials. Most of clinical trials are conducted on adults and in very rare clinical trials children’s are included. To raise the involvement of children’s into clinical trials the U.S. developed a regulatory and health strategy which focuses on overall market of drugs when pediatric clinical trials are included. According to the data of The World Bank Group, around 26% population out of the total world’s population includes pediatrics (children’s between the age group 0-14), instead of this the clinical trials conducted on adults are 10 times more than that of pediatrics because lack of infrastructure for pediatric clinical trials, ethical issues, also pediatric disease are relatively low than disease found in adults therefore the pharmaceutical companies focuses more on drug development for adults.
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However, in past few years the pediatric clinical trials have raised because the increasing need of pediatric medication also, due to increased understanding about the difference between the drugs for adults and for children’s. The awareness about the pediatrics drugs are already more in developed countries but in recent years it is increased massively in emerging nations also. Which created the broad consumer platform for pharmaceutical companies. As per the stats of U.S. Food and Drug Administration (U.S.FDA), as of February, 2017 total 935 pediatric study request received out of that 505 request issued (This data is for the request received for all types of drug study).
Currently, infectious disease segment holding major market share of pediatric clinical trials market, also the pediatric oncology market segment have seen high growth in recent years. The U.S.FDA have updated legislations and regulations to improve safety and effectiveness of pediatric drugs, medical devices and biological products used for children’s. Which will support the growth of pediatric clinical trials. As per this updated Food and Drug Administration Safety and Innovation Act, it is mandatory for pharmaceutical companies to conduct high quality research, also need to ensure about the formulations and forms of the drugs for children’s.
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Pediatric clinical trials market taxonomy:
Global Market by Phase of Clinical Trial
- Phase I
- Phase II
- Phase III
Global Market by Study Design
- Sequential Design
- Adaptive Design
- Bayesian Design
- Randomized Withdrawal Design
- Randomized Placebo-Phase Design (Rppd)
- Three–Stage Clinical Trial Design
Global Market by Geography
- North America
- Latin America
- Middle East
In pediatric clinical trials market, the North America is remained largest market share holding region followed by Europe and APAC. As per the study published by The Office of Pediatric Therapeutics (OPT), U.S. involved in around 86% pediatric clinical trials out of 346 clinical trials. While most of clinical trials are conducted in U.S. but the trend is changing now, like as per the data published by Future Medicine Ltd. in 2013, percentage of clinical pediatric studies conducted is highest in China followed by Russia and India.
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The driving factors of pediatric clinical trials market are legislative mandatory changes leading to the growth of pediatric clinical trials. As per the data of FDA, number of pediatric clinical trials conducted in last five years is more than the combined pediatric clinical trials conducted in last 30 years. Also, increased awareness about pediatrics drugs in emerging countries, more research and development in this area, increased disease rate in infants, increased burden of disease like diabetes in children’s and increasing involvement of contract research organizations (CRO’s) in pediatric clinical trials are the leading factors in the growth of pediatric clinical trials market.
There are some challenges in this market are like finding and getting the adequate number of children’s for clinical trial. It is very hard to convince the parents to include their child in clinical trial. Also the lack of infrastructure in emerging nations for pediatric clinical trials, updated and stringent rules of FDA in pediatric clinical trials area. Before initiating the pediatric program by FDA only 20% drugs were labeled that they are for pediatric use, other drugs have not been approved by FDA and are called as off-label drugs. Due to necessity doctors prescribe them routinely. Now, due to improvement in Food and Drug Administration Safety and Innovation Act there is growth observed in labeled drug which mentions the drug is for pediatric use. Also the pediatric market is smaller than adults market which limits earning potential and due to high risk in pediatric clinical trials than adult clinical trials limiting the overall growth of pediatric clinical trials market.
Some are the companies and research institutes involved in pediatric clinical trials are Genentech Inc., Children’s National Health System, INC Research etc.
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