Paediatric Research Consultancy: core services
- Writing/re-writing paediatric information sheets and consent/assent forms
- Re-wrting adult trial information sheets
- Paediatric reserach in-house training and workshops
- Paediatric protocol feasibility
- Paediatric Investigation Plan (PIP) feasibility
- Paediatric trial recruitment/compliance
- Practical paediatric trial management advice
- Ethical advice
- Consent/assent in paediatric clinical trials
- PRC expert network
- UK investigator site assistance
Please email PRC if you require further information
Writing/re-writing paediatric information sheets and consent/assent forms
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The information requirements for paediatric clinical trials can be complex and varied. PRC offers paediatric information sheets that are child friendly, age appropriate and are likely to increase recruitment and compliance. Cartoon artwork is also provided for younger children who cannot read but need to be included in the assent process. A template is usually provided based on UK requirements which can then be translated by the client and adapted to respect local etiquette of the individual country.
- Age appropriate and child friendly information sheets
- Easy language to help informe stressed parents
- Written by experienced children's writer
- Drawings for younger children by experienced artist
- Eases passage through Ethics Committee submissions
- Smoothes consent/assent in paediatric studies
- Improves recruitmend and compliance
- GIves added value to your paediatric clinical trial
- Very god value for money - and much, much
- Cheaper than medical communications companies
- Translated for paediatric studies all over the world
- Information sheets also written for adult studies
Further information and help regarding paediatric information sheets
Re-writing adult trial information sheets
PRC also offers to re-write clinical trial information sheets and consent forms to be easily read by adult patients and healthy volunteers. They comply with regulatory and ethical requirements and assist recruitment and compliance. As with paediatric clinical trials, research in an adult population requires careful communications planning to respect and meet the needs of research volunteers. People from all walks of life come with varying information needs. They may have poor eyesight, reading difficulties or English may not be their first language.
Poor quality information sheets are one of the main reasons for Ethics Committee review failure. Presenting information sheets that are clearly written and easy to understand helps improve ethics committee approval time and prevents costly delays to your drug.
Paediatric research in-house training, courses and workshops
PRC provides value for money, flexible paediatric research workshops and training sessions to fit in with your organisation's requirements. A pharmaceutical company client recently commented that PRC's paediatric trial training was "the most enjoyable, comprehensive and informative" they had ever heard.
Organisations seeking to conduct paediatric clinical trials may find it difficult to spare staff time or justify expensive conference & travel costs. In addition, advertised paediatric clinical trial course timings may not be convenient. PRC's paediatric research training is very cost effective as you can train any number of delegates in-house for the same price. Paediatric research training can also be performed at a time convenient to you.
Paediatric research in-house training is available anywhere where English is spoken and:
- Is tailored to your staff 's paediatric trial needs
- Is informative and enjoyable
- Gives staff confidence in paediatric trial management
- Helps avoid common paediatric protocol pitfalls
- Helps raise awareness of safety issues
- Helps avoid expensive paediatric study delays
- Saves staff time and travel costs
- Value for money
- Only requires one payment for many delegates
- An opportunity for in-depth problem solving
- Available anywhere in Europe where English spoken
- Wide selection of topics
Paediatric research training topics include but not limited to:
- Medicines for Children European Regulation
- Planning Paediatric Investigation plans to ensure studies are "do-able"
- Avoiding paediatric trial pitfalls to save wasting time and money
- Identifying and respecting paediatric trial needs
- Writing paediatric information sheets
- Practical aspects paediatric trial management
- Special considerations for very sick children
- Secrets of consent and assent
- Optimising your trial's recruitment and compliance
- Ethical aspects of paediatric clinical trials
- Smoothing the path of ethics committee applications
- Help with puberty and pregnancy test issues
- Effective and practical protocol planning
- Choosing paediatric investigator sites and CROs
Interested? Please complete and return a no-obligation training enquiry form
Paediatric protocol feasibility
This service takes a relatively short amount of time (usually about four hours) and is a valuable investment that will save companies time and money. PRC has quietly saved companies thousands of pounds by helping to ensure that paediatricians and busy family are not presented with final, unworkable protocols. PRC can help at the early planning stage by checking for practical and ethical pitfalls that can seriously delay recruitment, compliance and drug development time to market.
Where a paediatric trial is failing to recruit and risking costly slippage of deadlines, a paediatric protocol assessment will help a company to identify if major protocol amendments need to be made.
Paediatric Investigation Plan (PIP) feasibility
It is more important than ever the make sure that the trials proposed in the Paediatric Investigation plan are “do-able”. Otherwise companies may risk wasting massive amounts of time and money by committing themselves to a legally binding PIP that is impossible to do. From 27 July 2008 the EMEA will not grant a marketing authorisation application for a new drug without a PIP, deferral or waiver. A workable PIP is therefore essential to meet these regulatory requirements and ensure a safe passage of a drug to market.
PRC is able to assess PIPs for feasibility. Where the research topic is out of scope (e.g. stem cell), can refer client to a suitable company for assistance.
Further information about paediatric investigation plans
Paediatric trial recruitment/compliance
This is absolutely critical to the success of a paediatric clinical trial. PRC can offer advice on recruitment and compliance on a practical management level or offer paediatric protocol review at planning stage to ensure your study is “do-able”. There are strategies to assist recruitment and compliance, particularly around the consent/assent process. PRC also offers investigator site assistance in the UK on an ad hoc basis. Via the PRC expert network, clients may also take advantage of paediatric medical communications and mobile phone technology systems for compliance – especially important in testing medicines in a teenage population.
Practical paediatric trial management advice
With 17 years of paediatric pharmaceutical and academic trial management experience, PRC has a wealth of expertise to offer. This can save companies new to paediatric research much time and money during the learning curve and prevent them from “reinventing the wheel” of practical pitfalls common to paediatric clinical trial research. Where the research needs of the children and their families have been assessed by PRC and implemented by the client, usually recruitment and compliance is faster, easier and companies don’t need to use so many overseas research centres.
Ethical advice
PRC has much experience in paediatric clinical trial submissions in the UK. Each committee and protocol is different and sometimes ethics committees may not have members to have paediatric trial experience. It is a requirement in the UK for an ethics committee to obtain external paediatric advice if it is not available among members but other countries vary.
PRC can help by assessing the protocol for the main issues likely to be of concern to the ethics committee and the public. This is useful in both ethics committee applications and also for writing informed consent/assent documentation for children and their parents.
PRC will also perform full or partial UK Ethics Committee applications, depending on client requirements.
Information about ethical aspects of paediatric clinical trials
Help with Ethics committee applications
Consent/assent in paediatric clinical trials
This is an area of specialist interest to PRC who seeks to balance the needs of company with the research needs of children and their parents to facilitate optimum recruitment and compliance. Consent/assent requirements vary from country to country and PRC respects the needs of local research communities to ensure an ethical approach to paediatric trial research – which benefits both company and family.
Further information about consent/assent
For help with Consent/assent, please contact PRC for further information.
PRC expert network
Where PRC is asked for assistance which is outside scope of services, companies may be referred if they wish to companies or individuals with the relevant experience that PRC thinks could help. For transparency some of these companies provide a commission, some do not. A referral will be made in the best interest of the client.
The expert network is growing all the time and advice/help is available for the following:
Research PlanningScientific advice
Formulations
Study management
UK investigator site assistance
This is provided on an ad hoc basis e.g. to provide holiday cover for a paediatric research nurse, help with recruitment or paediatric clinical trial documentation. (e.g. prior to regulatory inspection) If PRC is unable to provide such cover due to prior client commitments, help may be available from the PRC expert network.