Clinical trial regulation

Clinical trials are of critical importance in achieving continuous improvement in patient outcomes and improving survival rates for patients with acute illnesses.

Europe's 21,000 hospital pharmacists are the secondary and tertiary care sector's experts in medicines, pharmacotherapy and pharmacokinetics and therefore play a central role in the implementation and conduct of clinical trials in all European countries on a daily basis.

This experience of hospital pharmacists in clinical trial regulation has led the profession to jointly call for:

- a single european electronic portal for submitting trials for assessment;
- greater distinction being made in the assessment process between high risk and low risk trials;
- a process to be created to enable multi-sponsor trials; and
- more open access to clinical trial data, including making it a condition of licence applicants to publish all available trial data provided to the European Medicines Agency in peer-reviewed Journals.

The EAHP is also calling on the European Commission and regulatory authorities to recognise the problem of under-participation in trials by key patient groups such as children, the elderly and females and explore regulatory solutions to the problem.

Read the EAHP statement on clinical trials here

EAHP's response to the European Medicines Agency consultation on publishing clinical trial result information (September 2013) is available here and here.

 

EAHP also encourages hospital pharmacists and members of the public to sign the Alltrials petition calling for greater transparency in the reporting of clinical trials - sign the petition at http://www.alltrials.net/ 

 

Last update: 20 October 2014