Japan Pediatric Society Drug Development Network (JPeDNet)

About JPeDNet

Japan Pediatric Society established the Japan Pediatric Society Drug Development Network (JPeDNet) in 2017 and acts to promote pediatric trials with high quality standards on a national scale. JPeDNet is registered as a Category 3 network at the European Network of Paediatric Research at the European Medicines Agency (EnprEMA: enprema.ema.europa.eu/enprema/index.php) and functions as a one-stop shop for consultation service on pediatric drug development by pharmaceutical companies and their in-country clinical caretakers in collaboration with representatives from Japanese pediatric sub-specialty networks.
The network activity was originally funded by the Japan Agency for Medical Research and Development from 2017 to 2019 and is currently funded by the Ministry of Health, Labour and Welfare (MHLW), Japanese health authority. JPeDNet collaborates closely with the Pediatric Clinical Trial Network (PTCN) Japan, which is a network that conducts clinical trials and consists of 55 hospitals (https://pctn-portal.ctdms.ncchd.go.jp).
The JPeDNet can organize a working group with sub-specialists in specific therapeutic indications, clinical research coordinators/ research nurses knowledgeable in pediatric clinical trials, a pediatric clinical pharmacologist, and a regulatory science expert. In cases where the targeted disease encompasses multiple areas of expertise, a joint working group from multiple sub-specialties can be organized. The working group can give advice on various aspects of pediatric drug development and clinical trials in Japan.

Examples of support/consultation available free of charge:

1. Advice on the feasibility of development and conduct of clinical trials
2. Advice on feasibility and protocol framework at the early stage of development planning including consultation to determine go or no go
3. Advice on implementation of global clinical trials and collaboration with global development teams in English (e.g., specific situations of Japanese clinical sites, needs and suggestions for improvement of protocol and clinical trial infrastructure)
4. Introduction of potential medical experts and provision of clinical expertise on the target disease
5. Advice on clinical trial protocols and study design
6. Feasibility of clinical trials and number of patients based on a quick survey of Pediatric Clinical Trials Network, support to select sites for clinical trials, and referral to the secretariat of the Central Clinical Trial Review Committee of the PCTN Japan
7. Number of patients and their medical information such as laboratory values at medical institutions (10 children’s hospitals and 31 pediatric clinics) using the Pediatric Medical Information Collection System (Please see below)
8. Advice on possible solutions to trial delays and support in patient recruitment (e.g., surveys through academic societies and PCTN Japan)
9. Advice for PMDA consultations
10. Specific advice on various other issues during clinical trials
11. Initial advice on responses and answers to inquiries from the PMDA after submission for approval
12. Appropriate advice on risk management plan

Initial consultations and advice stated above are provided free of charge. This is possible because the project is funded by the MHLW. Repetitive supports by medical experts are also possible, but individual contracts and appropriate fees may be requested by the experts for continuous consultation/advice.
It is possible to hold multiple meetings with the same working group free of charge in the following circumstances:

Example of multiple consultations free of charge:

1. Consultation with the domestic development team followed by another consultation with the global team
2. After consultation with the working group, another meeting for practical consultation with the clinical research coordinators/research nurses regarding the practical implementation of the clinical trial.
3. Give advice on feasibility and protocol concepts in early development phase, and then later advice on study design and site selection as soon as the draft study plan is finalized.

Pediatric Drug Information Collection Network:

There is a database to collect patient information from electronic medical records from 11 hospitals and 31 clinics. Pharmaceutical companies requesting consultation with JPeDNet can also request to quickly and efficiently collect information of patients with a certain diagnosis, including their demographic information, , laboratory values and prescriptions. This service is also free of charge for now.

How to contact us:

We will respond to your request and support you as much as possible. Please feel free to contact us at our e-mail address (jps-yakuji@jpeds.or.jp * To prevent spam mail, “@” is in double-byte characters. Please use lower-case half-width characters for “@”).
Considering the possibility of continued support, we strongly recommend that you contact us with in-country clinical caretakers from the clinical research organizations in Japan (Please see https://www.jcroa.or.jp/english/), but we can also give you advice in English for an initial consultation.

Necessary Documents to be submitted

After signing a nondisclosure agreement, consultation will be initiated. Please submit the following information:
1. Outline of development strategy and drug profile
2. If applicable and possible, the pediatric drug development plan in Europe and the U.S, i.e., Paediatric investigation plans (PIP) in the EU and/or Pediatric study plan (PSP) in the U.S.
Please submit the application documents in PDF format and set a password for each, or compress the application documents into ZIP format, set a password, and send it as an email attachment. If the application is submitted via mail, please enclose a CD-ROM containing a PDF file of the application documents.
e-mail to: jps-yakuji@jpeds.or.jp * To prevent spam mail, “@” is in double-byte characters. Please use lower-case half-width characters for “@”
Mail to: Committee on Pharmaceutical Affairs, Japan Pediatric Society
Suidobashi Sotoboridori Bldg. 4F, 1-1-5 Koraku, Bunkyo-ku, Tokyo 112-0004, Japan
Please send by registered mail, or mail with other traceable method.