Paediatric Research Consultancy

Background: 50% of medicines for children in European hospitals have not been tested for the children who are given them. Prescribing errors, lack of paediatric formulations or confusing medication labelling has resulted in injuries to babies and children, a few of which were fatal. This has led to public and UK parliamentary concern. (House of Commons debate / House of Lords report)

Legal basis: A mandatory regulation (not a more flexible directive) requiring and rewarding companies as appropriate to test medicines on children - became law across al Member States 26 January 2007.

Activity: A Paediatric Committee (PDCO) meets regularly at the European Medicines Agency (EMEA) in London. It will assess company Paediatric Investigation Plans (PIPs) provided by pharmaceutical and contract research companies. It is hoped that this Regulation will improve the safety and efficacy of medicines for children.

Effects on pharmaceutical industry: It will bring tremendous opportunities and challenges for the pharmaceutical industry and have a profound effect on the entire drug development process. It will also bring financial rewards to companies to offset the cost of paediatric research. See: Lamprill J (Nov 2006) Paediatric Regulation: Reasons to be Proactive: Scrip Drug Delivery p 9-11

Paediatric Regulation - brief update - 29 January 2009

MAAs and line extensions: must have a compliance checked Paediatric Investigation Plan (PIP) that has either paediatric data, deferral or waiver for each defined paediatric age group subset on submission to any medicines authority in Europe or the application will be rejected.
PIPs: The Commission Guideline for writing PIPs has been clarified and revised as most PIPs were failing to meet the required level and detail of information. New guidance available on EMEA website. Unfortunately many PIPs are delayed at the "clock stop" stage while companies assess their research strategy in light of advice from the PDCO.
Feasibility checks: Companies need to be careful that they have not committed themselves to final unworkable paediatric plans and protocols with unrealilstic time lines. Please contact us if you require a value for money feasibility check

Paediatric Regulation: help with PIPs and other services

Paediatric Investigation Plan assistance

Writing
PRC does not write PIPs but can recommend companies who do.

Review
This is a cost effective service as it may prevent delays caused by slow recruitment caused by protocols that are not focused on the research needs of children and their families. PIPs are legally binding. Therefore companies who fail to complete studies in the time they specify will have to apply for a modification to their PIP. In the worst case scenario this could cause failure of MAA if this is not done on time.

Practical: PRC can review PIPs to help ensure that the proposed paediatric research committed to in the legally binding PIPs is "do-able" and likely to satisfy the requirements of the patient and healthcare representatives of the PDCO.

Ethical: PRC can provide an ethical feasibility review to help anticipate and ameliorate potential ethical issues of the proposed paediatric research outlined in the sponsor company's PIP. Several members of the PDCO have served on ethics committees and the European Commission is particularly concerned that studies should be conducted to the highest ethical standards.

Further information
Can be found here

Help
Please get in touch if you require assistance

Other PRC services to assist your paediatric clinical trial

Advice

Paediatric protocol feasibility

Paediatric investigation plan assessment

Practical aspects of trial management

Fertility and pregnancy test issues in child volunteers

Ethical feasibility

Strategies for informed consent/assent

Good practice for improved recruitment and compliance

Paediatric trial rescue

PRC expert network

Writing PIPs

PK/PD advice

small metabolite analysis

health economics

legal services

paediatric IT communications

Writing

Age specific information sheets

Parent sensitive information sheets

Written by children's author

Artwork available for younger children

Consent/assent forms

Age appropriate fertility information

Adult study patient information

Articles about paediatric clinical trials

PIL leaflet for paediatric medicines (under supervision)

Training

Paediatric conference speaker

In-house training and workshops

Tailored to suit company requirements

Informative and enjoyable

Anywhere in Europe

UK investigator site assistance

Please get in touch if you require help

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