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Medical trials

Issues > Health > Medical trials

Medical trials are necessary for the development of new medicines.  However, certain requirements have to be met, including steps to ensure the right to health of children taking part in medical trials.  These include, but are not limited to, obtaining the prior informed consent of either children or their legal guardians.

Key reports


Children's Rights and the Pharmaceutical Industry

Child Rights Information Network, May 2012

Informed consent: Enforcing pharmaceutical companies’ obligations abroad
Stacey B Lee, lecturer of business law and ethics in the Johns Hopkins Carey Business School, USA, in Health and Human Rights Journal, 2010

Meeting Report: WHO and StaR Child Health: Use of Standards in Paediatric Clinical Trials in Developing Countries
WHO and StaR Child Health, 28 Oct 2009 

Bodies for hire; The outsourcing of clinical trials [India]
Sandhya Srinivasan, Himal (India), 1 Aug 2009

Summary profile of lawsuits against Pfizer over Nigeria drug trials
Business & Human Rights Resource Centre, Mar 2009 

Survey of current guidance for child health clinical trials
F.N.J. Frakking, J.H. van der Lee, T.P. Klassen, M. Offringa, for the StaR-Child Health Group, 2009

Drug trails in children: Doubts and dilemmas
Bharat Dalvi, 2008 

Testing new pharmaceutical products in children: A positive step, but ethical concerns remain
Alastair G Sutcliffe, senior lecturer in paediatrics, Royal Free and University College Medical School, in British Medical Journal, 11 Jan 2003

Case examples

Argentina fines drug fim over baby deaths
Al Jazeera, 14 Jan 2012
$230,000 fine imposed by court on GlaxoSmithKline after 14 babies died during vaccine trials - company to appeal ruling

Victim in legal battle over infant drug trial
Patricia McDonagh, Independent (Ireland), 20 Aug 2010

Summary profile of lawsuits against Pfizer over Nigeria drug trials
Business & Human Rights Resource Centre, Mar 2009 

Drug trials in India under investigation after 49 babies die at leading hospital
Rhys Blakely, Times (UK), 20 Aug 2008

Watchdog was not told of drug trial
Bellinda Kontominas, Natasha Wallace, Gerard Ryle, Sydney Morning Herald, 21 Nov 2007
Watchdog not informed about trial, pregnant women may not have given informed consent – family of boy born with cerebral palsy won case against hospital.

Wyeth drug tests fall foul of watchdog
Radhieka Pandeya, Livemint.com (India), 15 Nov 2008
Child with pre-existing cardiac disorder should not have been included in trial, violation of rules.

Is GlaxoSmithKline behaving badly in Argentina? Parents allege pharmaceutical giant tricked them with experimental vaccine
Aina Hunter, ABC News, 23 Sep 2008

Deaths of 16 babies in health trial ‘inevitable’
Vanessa Thorpe, Independent (UK), 24 Aug 1998

 

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Related stories and components

Article
14 January 2012

[video] Argentina fines drugs firm over baby deaths

Author: Al Jazeera

GlaxoSmithKline has been fined $230,000 by a court in Argentina after 14 babies died during trials of a vaccine called Synflorix. The British pharmaceutical company has been criticised over the way it handled the testing.

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Article
20 August 2010

Victim in legal battle over infant drug trial [Ireland]

Author: Patricia McDonagh, Independent [Ireland]

A WOMAN subjected to a controversial vaccine trial as a baby without her mother's consent broke her silence last night to reveal her traumatic decades-long fight for justice...She…is…preparing a class action in the US courts against the multinational...

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Article
28 October 2009

[PDF] Meeting Report: WHO and StaR Child Health: Use of Standards in Paediatric Clinical Trials in Developing Countries

Author: World Health Organization (WHO), StaR Child Health

In a…meeting in Amsterdam…different aspects of…child health trials in developing countries were discussed. The quality of pediatric clinical trials in low and middle income countries…should be improved…There are question about how to give appropriate...

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Article
1 March 2009

Summary profile of lawsuits against Pfizer over Nigeria drug trials

Author: Business & Human Rights Resource Centre

In 1996, Pfizer conducted a drug trial in Kano, Nigeria during an epidemic of bacterial meningitis. The company tested an experimental antibiotic drug, Trovan, on about 200 children during this time...plaintiffs...claim that the drug trial led to the...

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Article
1 January 2009

[PDF] Survey of current guidance for child health clinical trials

Author: F.N.J. Frakking, J.H. van der Lee, T.P. Klassen, M. Offringa, for the StaR-Child Health Group

[B]etween 50 and 90% of daily prescriptions for sick children use ‘off label’ drugs…legislations were introduced to stimulate the pharmaceutical industry to investigate the pharmacological effect and safety of both new and existing medicines in...

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Article
15 November 2008

Wyeth drug tests fall foul of watchdog

Author: Radhieka Pandeya, Livemint.com [India]

Patient trials of an advanced pneumonia vaccine by the domestic unit of US drug giant Wyeth Inc. have been suspended by India’s drug quality regulator after the death of an infant on whom the vaccine was tested in a trial in Bangalore...The child had...

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Article
23 September 2008

Is GlaxoSmithKline behaving badly in Argentina? Parents allege pharmaceutical giant tricked them with experimental vaccine

Author: Vanessa Thorpe, Independent [UK]

[I]n Santiago del Estero, an Argentine province…[a]5-month-old died…[She]had been one of more than 13,000 Argentine children to participate in a clinical study implemented…by…GlaxoSmithKline…to test the efficacy of [an] experimental pediatric...

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Article
20 August 2008

Drug trials in India under investigation after 49 babies die at leading hospital

Author: Rhys Blakely, The Times [UK]

Forty-nine babies have died in drug tests at…the Delhi-based All India Institute of Medical Sciences (AIIMS)…The victims were among the 4,142 infants who were used in…clinical trials…since…2006, many for Western companies…Campaign groups have voiced...

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Article
1 January 2008

Drug trails in children: Doubts and dilemmas

Author: Bharat Dalvi, Annals of Pediatric Cardiology

There is no denying the fact that clinical trials in children need stringent scrutiny of design and very close monitoring during execution to avoid life threatening complications…However, the question…is whether or not clinical trials should be...

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Article
21 November 2007

Watchdog was not told of drug trial [Australia]

Author: Bellinda Kontominas, Natasha Wallace, Gerard Ryle, Sydney Morning Herald

Doctors responsible for a drug trial on pregnant women at Wagga Wagga Base Hospital [Australia] may not have obtained the informed consent of all the mothers and went ahead without telling the drug watchdog…Hundreds of women were given the…drug...

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