Can Patient Group Directions (PGDs) be used to supply or administer a medication which is part of a clinical trial, study or pilot?

There is nothing in legislation that prevents the use of PGDs in clinical trials, studies or pilots if the medicine has a product licence and all other legal and good practice requirements relating to PGDs are met.

Often medicines administered or supplied under a PGD as part of a clinical trial, study or pilot are not actually part of the investigation which is more commonly focused on the service design, delivery or patient group.  Examples include use of a vaccine in a population outside the national immunisation schedule or the supply of PreP as a programme pilot.

The UK licensing status of the medications involved must be considered.  If the medication use is off label this is permitted under a PGD, but this must be acknowledged within the PGD as stated within the NICE guidance and must be clearly justified by best clinical practice.  Unlicensed medications (those without a UK licence or Market Authorisation) cannot be supplied or administered under a PGD in any circumstance

Organisations may wish to seek advice and support from their local Clinical Trials team.

https://www.sps.nhs.uk/articles/can-patients-receive-medicines-under-pgd-when-they-are-used-outside-their-licensed-uses/

https://www.nice.org.uk/guidance/mpg2

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