Appendix 2: Clinical trials collaboration

Collaboration between NHS and commercial organisations on clinical trials is essential to the development of new medicines. The ABPI has produced a guidance series to support this critical process. All parts of the guidance are under regular review to ensure they are consistent with the latest regulations.

Phase 1 guidelines

The 2018 edition of the ABPI guidelines reflects the current EU legislation for the performance of Phase I clinical research as set down in the EU Clinical Trials Directive. Until the Clinical Trials Regulation EU No 536/2014 becomes applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive. In addition to regulatory changes, this new edition now also incorporates the previous ABPI First in Human Studies guidelines4.

Model Clinical Trial Agreement (mCTA)

The ABPI has worked with the four home nations to develop a model Clinical Trial Agreement for commercial clinical research. We continue to work together to keep this single template agreement up to date. This collaboration also develops guidance to assist understanding of the template agreement5.

Clinical Trial Compensation

The ABPI also produces guidelines on clinical trial compensation for use in clinical trials in the UK6.

4 https://www.abpi.org.uk/publications/guidelines-for-phase-i-clinical-trials-2018-edition/

5 https://www.ukcrc.org/regulation-governance/model-agreements/

6 http://www.abpi.org.uk/publications/ct-compensation