Paediatric Research Consultancy

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.

Jane is also:

Member of the European Forum for Good Clinincal Practice Children's Working Party that meet regularly in Brussels concerning the new paediatric regulation
Fellow, Institute of Clinical Research, and member of the ICR Special Paediatric Interest Group
Visiting Research Fellow at the Department of Paediatric Clinical Trials, School of Pharmacy, University of London
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.
Co-author with Patricia Fowler of book chapter on consent and assent in "Guide to Paediatric Clinical Research" recently published by Karger Medical Publishing.
Regular speaker at international conferences
Written many helpful publications concerning different aspects of paediatric clinical trials, which are available to clients free of charge.

How paediatric clinical trials might fail

Every year, thousands of pounds 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

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.

Paediatric Research Consultancy (PRC) Client comments

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

Client	Comment
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

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.

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