Home > Property & Casualty > ABPI sets new clinical trials standards; compensation regulations amended

ABPI sets new clinical trials standards; compensation regulations amended

lab06The Association of the British Pharmaceutical Industry (ABPI) recently released updated guidelines for all UK clinical trials beginning January 1st, 2015. The standards consist of two main sections:

  • Phase 1 Clinical Trials Compensation Guidelines
  • Phase II, III and IV Clinical Trials Compensation Guidelines

The new guidelines seek to remove the different compensation arrangements for “healthy” versus “patient” volunteers in clinical research studies. Following periodic reviews and assessments of both sets of guidelines, the ABPI no longer considers a distinction between the two ethically appropriate, since there seems to be no reasonable prospect of direct benefit from participation, regardless if the participants involved in Phase 1 studies have the target disease or not.

Click here to read the new guidelines, including all consequential changes to compensation regulations for Phase 1 and Phases II, III and IV Clinical Trials. Companies conducting UK trials which are covered on a non-admitted basis under a USA/global policy via a “No Fault Compensation” endorsement should review the new standards and discuss the changes with a WGA representative to ensure their policies comply with the latest guidelines.


About the Author

Priscilla Walsh is a Vice President at WGA and specializes in the Life Sciences industry as well as Foreign Clinical Trial placements.

617.646.0260 | PWalsh@wgains.com | Connect with Priscilla on LinkedIn |

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