Tuesday, November 19, 2013

Children in Clinical Trials

Today's post comes from Ashley Smith. She is GxP Editor at Whitehall Training, a leading supplier of online training courses for the pharmaceutical sector. He is a regular blogger and is particularly interested in the subjects of pharmacovigilance, GCP and GDP.

Testing new drugs on children is an emotive subject. The very idea seems to be an awful breach of the duty of care shared by all parents and guardians. However, the sad truth is that only a minority of the drugs many children rely on have actually undergone pediatric trials – less than 50% in the US for example. Time and again, pediatric trials show that treating children as “little adults” just isn’t good enough.

This is why there are internationally recognized rules for those wishing to have young participants in pharmaceutical trials. These from part of the Good Clinical Practice rules laid down by the International Committee on Harmonization.

It is important that clinical research is conducted on all groups of patients who might benefit from the use of the medicine under test. This can mean that testing should be carried out on children. The flip side is that drugs for a condition not seen in children should not generally be tested in them.

The definition of a child (or minor) varies from country to country. In general, it’s safest to class all patients under the age of 18 years as minors.

A child’s legal representative may give consent to take place in a trial on their behalf. Even where this is true, the child should be given information to the fullest extent of their understanding. If possible they should sign and date the consent as well.

It is important that consent forms are tailored to the age of the patient – even if this means producing several different forms for a single trial. For example, a consent from aimed at children younger than six may use pictures to try and get the information across.

Minors approaching adulthood may review and sign the consent forms themselves but for younger patients, their parent or guardian should review and sign the forms and the child should review and indicate their agreement (in writing where possible) to the trial.

Independent ethics committees (IECs) exist to safeguard the safety of trial participants and they pay special attention to trials involving children. The consent forms need to be authorized
by an IEC and where children are involved, it would usually call on specialist advice when approving the trial.

To make sure that all trials follow the same rules, everyone involved in their operation needs to have received proper, regular training, such as the online version offered by Whitehall Training.

Whilst the concept of testing drugs on children may be emotive, isn’t it better to know that the drugs used to treat the many serious childhood diseases really are both safe and effective?

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