Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Benefits of using PRC
  • Service overview
  • Ethos
  • About PRC
  • Short biography
  • Why paediatric trials fail
  • Preventing trial failure
  • Client comments
  • Business etiquette
  • Exclusions
  • Core Services
  • Paediatric info sheets
  • Adult trial info sheets
  • In-house trial training
  • Protocol feasibility
  • PIP feasibility
  • Recruitment/compliance
  • Practical advice
  • Ethical advice
  • Consent/assent advice
  • PRC expert network
  • UK site assistance
  • Information
  • Paediatric clinical trials
  • EU paediatric regulation
  • PIPs
  • Ethical aspects
  • Paediatric info sheets
  • Consent/assent
  • Ethnic considerations
  • Useful publications
  • Useful links
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  • About Paediatric Research Consultancy

    Paediatric Research Consultancy - Short Biography

    Paediatric Research Consultancy™ is passionate about enabling the ethical and smooth running of paediatric clinical trials. The picture shows a nurse listening to a girl's heart rate

    Paediatric Research Consultancy™ is owned and managed by Paediatric Research Consultant Jane Lamprill RN RSCN FICR. She has 17 years experience as a Paediatric Research Sister (Senior Study Site Coordinator) managing both pharmaceutical and academic paediatric clinical trials. She is also a specialist medical writer and a published children's author. Expertise in writing age-appropriate information for children and their parents has assisted many companies over the years. She is sensitive to the needs of families while testing medicines for children. Jane has a global outlook and her information sheets have been translated into many languages for paediatric clinical trials around the world.

    Please note the  Jane Lamprill on facebook is not the same person!

    Jane is also:

    • Member of ethics panel for review of 7th Framework Protocol (FP7) and European Research Council (ERC) grant applications, European Commission
    • Fellow, Institute of Clinical Research, and founder member of the ICR Paediatric Advisory Group
    • Co-investigator at the Royal Brompton & Harefield NHS Trust & Imperical College London, currently writing up research on retrospective study to evaluate attitudes and perceptions of child and parent paediatric project participants to inform future best practice.
    • Member EMWA  European Medical Writers' Association
    • Co-author  book chapter on consent and assent in "Guide to Paediatric Clinical Research"  by Karger Medical Publishing
    • Former member of the European Forum for Good Clinincal Practice Children's Working Party that met regularly in Brussels and gave evidence to European Commission prior to new EU paediatric regulation
    • Former member of the European Forum for Good Clinincal Practice Children's Working Party that met regularly in Brussels and gave evidence to European Commission prior to new EU paediatric regulation
    • Regular speaker at international conferences
    • Written many helpful publications concerning different aspects of paediatric clinical trials, which are available to clients free of charge.

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    How paediatric clinical trials might fail

    Every year millions of dollars are wasted by research companies due to slow recruitment and non-compliance in paediatric cllinical trials. Some try to adapt adult protocols for use in children. This results in doctors being presented with protocols that:

    • Are final, non-workable and non-negotiable
    • Are too complicated and ask too many research questions at the same time
    • Contain impossible inclusion and exclusion criteria
    • May impose unethical requests from regulators
    • Have too many blood tests or invasive procedures
    • Are not “do-able” for a busy family
    • Fail the consent and assent process
    • Parents and children are unable to understand the legal and medical jargon on the information and consent forms.
    • Fail at the ethics committee submission stage

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    How Paediatric Research Consultancy helps prevent failure

    When companies have used this paediatric clinical trial service, medicines for children were was helped to market faster because:

    • Studies had fewer problems obtaining Ethics Committee approval.
    • Information sheets were understood by the parents and children which helped recruitment
    • Higher child participation and compliance during the trial.
    • Research ran more smoothly as potential pitfalls were eliminated at planning stage
    • Medicine got to market faster enabling an earlier sales advantage over competitors
    • Therefore faster access to safe effective treatment for children.

    Please contact PRC for further information.

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    Paediatric Research Consultancy (PRC) Client comments

    For commercially confidential reasons, some of these true comments have been anonymised:

    Client Comment

    Project Manager
    Dutch Office
    Global pharma
    December 2011

    Your input regarding the protocol and your feedback for the artist during the development of the line drawings was much appreciated. You are clearly very experienced with setting up paediatric trials and with developing consent pictures

    GCP Inspector
    Global Pharma company
    June 2011
    Thank you so much for the [paediatric ethics] information - really good to work with you
    Max Clayton-Robb
    Pharmaceutical
    Conference Producer, SMi
    June 2011
    SMi's  Preparing a Paediatric Investigation Plan Master Class, London:
    Jane chose the speakers, chaired the day and spoke on Ethical aspects of paediatric investigation plans to help prevent delays.  
    All of the speakers got 4s and 5s across the board on the evaluation forms so that was good to see. The highest marks came for relevance of content, well researched and stimulated discussion which are the most critical for the master class environment. The average overall score for the master class was 4.5 which is very high indeed
    Clinical Science Manager
    Global Pharma Company
    May 2011

    Supervised and assisted with informed assent pictures for extremelty complex study for 5-6 year old Western and Chinese children
    Many thanks to you and your artist for your work and respect of the timelines

    European Centre of
    Pharmaceutical
    Medicine, Basel
    November 2010

    We would like to thank you for your excellent contribution at the "ECPM Seminar on Ethics and Regulations in Clinical Research" . According to the .. participant evaluation .. the lectures and the overall performance of the faculty were hightly appreciated.

    Tarley Cameron
    Conference Producer
    Pharmaceutical Division
    SMi Group London
    March 2010

    Accelerating Patient Recruitment and Retention in Clinical Trials. 
    ...it was a delight to work with you in producing such an enjoyable and well received event. Overall, your talk rated 4.3/5 so you did an excellent job and the presentation was extraordinarily well received:
    Excellent! Nice presentation style. Comprehensive knowledge of paediatric studies. Well presented. Gave key messages well. Gave good examples. Very interesting. Should have said before (that) the presentation wasn't on CD. Interesting. Completely new area.

    Study Manager, Clinical Operations, global pharmaceutical company.
    December 2009

    [Regarding PRC prepared parent and child information and consent/assent forms & artwork for younger children taking part in a early phase paediataric clinical trial] I have finally got all the documents finalised incorporating all review comments from the team and legal! Ready for Submission! Thanks for all your help in this process, you have been a valuable asset to the team :0)

    Paediatric conference executive, London
    October 2009

    I was delighted to have you at the conference. Your contributions are so valuable to remind people that despite all business we should always get back to children's needs at the end of the day.

    Trainer/Adviser
    Medical Division (UK)
    Global Pharma Company
    July 2008

    Jane provided a very high standard of training which was extremely well received by all the participants. Everyone who attended the sessions took back very useful tools to employ in thier day to day work.
    Michelle Noble, Head of Membership Services, Institute of Clinical Research, UKl
    June 2008

    Just a very brief line to say a massive thank you for speaking at the Institute of Clinical Research Ethics and GCP Forum on Monday. Your presentation and the Forum in general were a great success.

    Medical Director, Clinical Science, Global pharma company, UK office
    April 2008

    I wanted to personally thank you for your particpation in our [paediatric] seminar last Wednesday. I got excellent feedback from everybody and they have enjoyed and learned a lot with your talk. We hope to have you in future meetings we are planning to organise.
    Dr Madhu Davies, Organiser
    BrAPP Annual Symposium
    British Association of
    Pharmaceutical Physicians
    March 2008
    Jane, thank you for debunking so many of the myths around encouraging parents and children to take part in clinical research. An excellent and engaging presentation and so very well received.
    Medical Writer
    Consultancy, Germany
    January 2008

    Thanks very much for your interesting talk ...it was refreshing to get the information from someone with intimate knowledge of the practicalities of pediatric trials.

    Course Director
    Conference Company UK
    January 2008
    It was a pleasure to meet you again at the meeting last week and thank you for an excellent presentation.

    Managing Director
    Regulatory Affiars Agency UK,

    I want to congratulate you on a most stimulating and informative talk, for me it was the best one ...
    Manager Scientific Affairs
    Biotech company UK
    Everyone thoroughly enjoyed your presentation and I would like to echo again the comments regarding the high quality of your presentation

    R&D Manager
    (same Biotech Company as above)

    I have been to many paediatric clinical trial presentations, and yours was the most informative and comprehensive I have ever heard
    Project Manager, global pharmaceutical company UK office We enjoyed meeting you and found the information you gave us very helpful.
    Paediatric pharmacy MSc student, School of Pharmacy, University of London I was enlightened by your very informative training about paediatrics
    Senior CRA, pharmaceutical company delegate, international paediatric conference Thanks again for a great presentation.
    Project Manager, CRO, UK office We recruited 90 patients in 10 weeks after you helped us.
    Project Manager, global pharmaceutical company, UK office We had a smooth passage through ethics commmittee submission with the information sheets you wrote.
    International conference company paediatric study day, UK Thanks for your presentation - there was a lot of discussion and we received very good feedback from attendees.
    Senior CRA, pharmaceutical company, Finland I truly enjoyed your workshop and the conference ... I will keep an eye on your website and it's good to know who I can contact in case we need help.
    Senior CRA, Global pharmaceutical company, UK office Thank you for your comments, they were very helpful in guiding our 'blue sky' meeting.
    Company Secretary Pharmaceutical company UK Thanks for your advice - I know feel assured about the future direction of our paediatric stragegy
    Project Manager, pharmaceutical company, Belgium Your work has been very useful.
    Emeritus president of prestigous international organisation ... thank you for sending the proofs of the article, Jane has a direct and engaging style which I could not wish to alter...
    Commercial lawyer, London Many thanks for the copy of your slides and for the excellent presentations. I shall certainly bear you in mind should any issues on pediatric competence arise.
    CRA, global CRO, UK office I was enlightened by your very informative training on paediatrics. Thank you.
    Managing Director, healthcare communications company, UK It was great to spend time with ou today and have the opportunity to share the proposed offering with you. We look forward to developing a long term collaborative relationship with you
    Principal Investigator, global cystic fibrosis study ethics application, UK You did a great job. All I had to do was sign and send.
    Project Manager, pharmaceutical company, Belgium Many thanks for having worked on the ICFs and consent forms. They look really good. They have been sent for internal approval at ......... and even approved already

    Clinical Project Manager, Europe. Global pharmaceutical company I would like to thank you for your work on the study assent forms. I think they were very well written

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    Business etiquette

    • PRC seeks to offer a transparent and ethical business service, and welcomes any feedback you may have.
    • PRC charges by 5, not 15 minute blocks to save client’s money as she does not see why companies should pay for time not worked.
    • All contracts come with a warranty that work will be performed to the best of PRC’s ability will comply to current ethical and regulator requirements.

    Exclusions

    Paediatric Research Consultancy does not offer advice on the following areas, but knows some good companies who can help in these areas via the PRC expert network:

    • Legal
    • Change management
    • General regulatory
    • Business Development
    • Commercial
    • Non paediatric clinical

    Paediatric Research Consultancy does not accept projects considered unethical.

    “Bobby compliant” website designed by Creative Eye. Photographs of children were sourced ethically and are “model released" I.e. written parental permission obtained for their child to be photographed and picture released to a photo agency. They are embedded to prevent unauthorised persons downloading pictures of children.

    © Copyright Paediatric Research Consultancy 2005-2007. Paediatric Research Consultant is the owner of copyright of this website and its original contents. No part of this website may be published, distributed, extracted, re-utilised, or reproduced in any material form except in accordance with the permissions set out below or as permitted by the Copyright Designs and Patents Act 1988. The following permissions DO NOT APPLY to content supplied by third parties. For permitted use of third party content apply to the relevant content owner.

    You are welcome to use material from this website on the strict condition you acknowledge Paediatric Research Consultancy and quote the website www.janelamp.co.uk or the relevant journal reference as the source of the material. Extracts must be quoted complete and unmodified.