clinical trials

Type 1 diabetes breakthrough

Much of the research for diabetes as a disease involves digital innovations such as fast and accurate meters, online recording systems or continuous monitoring and delivery meters. But many see these as a stop gap until the ‘holy grail’ of diabetes is achieved: an intervention to replace insulin production. Sometimes the best treatment can involve replacing or bypassing these digital innovations.

Successful […]

September 10th, 2015|Research|0 Comments|

Implementing transparency at the European Medicines Agency

Sergio Bonini, M.D., Hans-Georg Eichler, M.D., Noël Wathion, Pharm., and Guido Rasi, M.D., explain EMA’s policy and practice  about transparency and sharing of data from clinical trials. In:

Transparency and the European Medicines Agency — Sharing of Clinical Trial Data

N Engl J Med 2014; 371:2452-2455December 25, 2014

January 8th, 2015|Regulation, Research|0 Comments|

Definitions: Efficacy, Effectiveness, Efficiency

Borrowing from
John Marley, Professor, Department of General Practice, University of Adelaide, Adelaide
Aust Prescr 2000;23:114-5

Efficacy –  can a treatment work?
As in a clinical trial, i.e. in ideal circumstance of a controlled trial population.

Effectiveness – ‘the extent to which a drug achieves its intended effect in the usual clinical setting’

Effectiveness “can be evaluated through observational studies of real practice”; local and […]

Event: Farr Institute – ABPI Industry Forum 2014, London 16 December 2014

The Farr Institute of Health Informatics Research in conjunction with The Association of the British Pharmaceutical Industry and the UK Health Informatics Research Network will host the second Farr Institute Industry Forum at the Royal College of General Practitioners on 16th December 2014.

On the agenda:
Pragmatic trials and stratified medicine trials, with case studies presentations
How data based on real world […]

December 9th, 2014|Regulation, Research|0 Comments|

June 2014 – The new EU Clinical Trials Regulation: how NHS research and patients will benefit

A new EU law “will in particular allow for the speeding up of the process for authorising new clinical trials and reduce the administrative burden associated with the conduct of these studies….”

October 3rd, 2014|Regulation, Research|0 Comments|

Europe Innovative Medicines Initiative (IMI)

The Innovative Medicines Initiative (IMI) is Europe’s largest public-private partnership aiming to improve the drug development process by supporting a more efficient discovery and development of better and safer medicines for patients. The legislation establishing IMI 2 was approved by the EU Member States on 6 May 2014. IMI 2 will be launched later in 2014 and will run […]

May 9th, 2014|Research|0 Comments|