Sensible Guidelines for the Conduct of Clinical Trials
In 2007 several trials groups from McMaster, Duke and Oxford Universities organised an international meeting in Washington DC called "Sensible Guidelines for the Conduct of Clinical Trials" in order to discuss the difficulties involved in initiating and running randomised trials efficiently. It became clear during that meeting that many of the problems would require for their solution a coordinated response from academic trialist groups, regulatory agencies, pharmaceutical companies and health care providers worldwide. Papers arising from this meeting appeared in a special issue of Clinical Trials (2008, 5: 38 -84).
A follow-up meeting of the Sensible Guidelines group took place in Oxford on the 5/6th September 2009. The principal aims of this invitation-only meeting were to: (1) update our review of the main barriers preventing efficient trials; (2) share the experiences of those who are attempting to deal with these barriers; and (3) agree possible solutions to the main difficulties and encourage their promotion through international collaboration.
The BMJ published a follow-up article to this meeting on the 8th September 2009 (BMJ 2009;339:b3671). The meeting has also been referenced in an editorial in The Lancet Oncology published in November 2009 (Lancet Oncol 2009; 10:1021).
Agenda and Slides from September 2009 Meeting
Meeting agenda (PDF)
Session 1: Overcoming barriers to initiating trials
Session 2: Overcoming barriers to conducting trials
Session 3: Streamlining trials - what needs to change and how do we do it?
Please note that if the information from these slides is referenced in other work, that the original speakers should be appropriately acknowledged. Contact details for the meeting speakers are available by e-mailing: sensibleguidelines@ctsu.ox.ac.uk.
Assessment of the functioning of the EU “Clinical Trials Directive” 2001/20/EC; Public Consultation Paper
In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on "Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector", the Commission announced that an assessment would be made of the application of the Clinical Trials Directive. A public consultation document along this line is published here. Interested parties are invited to comment by 8 January 2010.
Should you have any queries about the Sensible Guidelines Group, please contact: sensibleguidelines@ctsu.ox.ac.uk.
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