Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Useful Paediatric Trial Publications for PRC Clients

    Jane Lamprill's publications  to inform your paediatric clinical trials

        Mother and child read together. Pediatric trial information needs to be informative and easy to understand. This web page contains links to some of Jane Lamprill's articles about consent and assent in paediatric clinical trials.

    LAMPRILL J & FOWLER P A (2006)   Informed consent and assent in paediatric clinical trials. Book chapter. Karger Medical Publishing, Basel, Switzerland. December. p 47-59.

    Informed consent and assent are very sensitive ethico-legal subjects. There are many layers of protection as testing medicines in children can only be done with permission of the ethics committee, the country medicines regulations body, the research doctor, the parent/legal guardian and if old enough, the child. It is essential that before parents and children agree to take part, they should be fully informed and receive information about the proposed research that is age appropriate and easily understood. This book chapter discusses the consent/assent process as well as the importance of managing a child’s dissent should they wish to stop taking part in the research at any time.

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    LAMPRILL J (Dec 2006) European Paediatric regulation – reasons to be proactive Scrip Drug Delivery Supplement , November 29, p9-11.

    Perhaps this should have the title ”wake up before you lose lots of money!” This article was published just before Regulation EC1901/2006 Medicines for Paediatric Use came into force in January 2007. It gives a useful background to the regulation with information about the opportunities and obligations for pharmaceutical companies applying for drug regulatory approval in Europe.

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    LAMPRILL J (May 2005) Paediatric Trials: Balancing profits & ethical safeguards. Clinical Research Focus. Institute of Clinical Research, Marlow. Vol 16 (2) p13-18

    The Paediatric Regulation from Brussels will mandate pharmaceutical companies test medicines on children - and be financially rewarded as paediatric trials are more expensive than adult studies. It is essential that children have safe, effective medicines but this needs to be balanced against the money companies will make. Pharmaceutical companies therefore need scrupulous ethical safeguards to ensure fully informed consent from parents and assent from the children. This will facilitate children's research needs and refute accusations of using children for profit.

    Clients please click here to order free PDF (usually same day response)

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    LAMPRILL J (April 2005) Teenage trials – a difficult phase? Good Clinical Practice Journal, Brookwood Publications Ltd. London. Vol 12 (4) p22-24

    Adolescents are one of the most neglected areas of paediatric (pediatric) research because trials are notoriously difficult to do. Peer pressure, pregnancy testing, concentration span, other time priorities e.g. friends, exams etc all contribute to challenges for the researcher. As a result little is known about the effect of many medicines on the different stages of puberty and their associated metabolism. This article explores some of the tricky issues and suggests strategies to assist recruitment and compliance.

    Clients please click here to order free PDF (usually same day response)

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    LAMPRILL J (2004) Paediatric Clinical Trials – a Wake Up Call for Pharmaceutical Companies in Europe. Monitor magazine, Association of Clinical Research Professionals. (ACRP) Vol 18 (2) p 15-18

    Serious medication errors due to the off-label and unlicensed use of medicines in the paediatric population have led the European Medicines Agency (EMA) and the American Food & Drugs Agency (FDA) to review the regulations for testing medicines in the paediatric population. (This article was published in Summer 2004 and is now slightly out of date following the Autumn announcement from the European Commission. It will however serve as useful background information).

    Clients please click here to order free PDF (usually same day response)

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    LAMPRILL J (Aug 2003) Prioritise and plan for children’s needs (to improve recruitment and compliance) Good Clinical Practice Journal, Brookwood Publications Ltd p17-19

    The needs of adults and children participating in clinical trials differ significantly. This article explains why paediatric studies must be child and family-focused if they are to run safely, smoothly and to schedule.

    Clients please click here to order free PDF (usually same day response)

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    LAMPRILL J (Aug 2002) Asking for children’s assent to take part in clinical research (Lead article) Good Clinical Practice Journal, Brookwood Publications Ltd p9-12,

    Obtaining consent from children and their guardians in relation to clinical trials is fraught with difficulties, and these will only increase as the pressure to conduct more paediatric trials intensifies. This article considers some of the implications of carrying out research in this vulnerable group. Please note that age of consent in UK is now 16. Article published prior to change in law.

    Clients please click here to order free PDF (usually same day response)

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    LAMPRILL J, (2001) Every-day ethics: Paediatric Clinical Trials (Lead article) Spaed-read Paediatric News Review, Intercern Vol 1 (2) p1, p6-7.

    Children are not small adults and have different needs and expectations when it comes to making sure their medicines are safe and effective. This has a huge impact concerning the ethics of using children in pharmaceutical studies as they have limited understanding and may not be able to make informed decisions. There is therefore a huge weight of ethical responsibility on the pharmaceutical researcher to “do no harm”

    Please click here to order free paper copy if you live in Europe

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    LAMPRILL J (1999) Medicines for Children Clinical Research Focus. Association of Clinical Research in the Pharmaceutical Industry (Institute of Clinical Research) December, p23-27.

    There has been debate in the recent academic press and media concerning medicines given to children which are off-label unlicenced and often without pharmokinetic or safety data for the age group because clinical trials have not been done. This article though published in 1999 , makes useful background reading to the reasoning behind the new Paediatric Regulation expected from Brussels late 2006.

    Please click here to order free paper copy if you live in Europe

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