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Largest clinical trial database in psychiatric research

10 November 2010

In a bid to accelerate drug discovery, NEWMEDS – an international academic-industry collaboration with King’s as its academic lead - has pooled resources to bring together data of 23,401 anonymised patients from 67 trials on 11 compounds in over 25 countries, to form the largest database of clinical trial data ever created in psychiatric research.

Despite tremendous growth in biomedical knowledge, the rate of development of new drugs has been slow, particularly in psychiatric disorders. Barriers include competition between rival companies and the limited exchange of science across the industry-academic divide.

In 2009, the Innovative Medicines Initiative (a joint undertaking between European Union and European Federation of Pharmaceutical Industries and Associations - EFPIA) launched a unique collaboration to address psychiatric drug development: NEWMEDS (Novel Methods leading to NeW MEdications in Depression and Schizophrenia).

Led by Dr. Tine Bryan Stensbøl, H. Lundbeck A/S and Professor Shitij Kapur, Institute of Psychiatry (IoP) at King’s, NEWMEDS brings together seven academic research institutions, nine major pharmaceutical companies and three small and medium-sized enterprises into one consortium.

It aims to overcome three major bottlenecks in developing models and methods in drug discovery for schizophrenia and depression:  lack of accurate animal models; lack of tools and tests in healthy volunteers that can provide early indication of efficacy; and reliance on a clinical trial methodology that has remained unchanged for 50 years.

To identify how modern clinical trials might be improved, the companies shared data to devise new ways of predicting which treatment is likely to work for which patient (individualized medicine) rather than using the standard trial-and-error system.

Prof Kapur, Dean at the IoP at King’s and NEWMEDS academic lead said:  'The landscape of drug development and scientific discovery is changing. After pioneering examples in the field of genetics where sharing data has led to new discoveries – we wanted to see how this could be done in the clinical arena. NEWMEDS is the first large scale example of such collaboration between industry and academia in this field in psychiatry. Hopefully, this will be one step that will help reverse the drought of new medications in psychiatry.'

Dr. Tine Bryan Stensbøl, the industry lead and coordinator of NEWMEDS said: 'The pharmaceutical industry model where each company in isolation tries to solve precompetitive problems is being challenged by NEWMEDS. We have successfully identified a precompetitive match between competing companies and strong academic centres in Europe.  Data from clinical trials run by individual EFPIA companies are brought together for new areas of research, relevant not only to academic research but also to EFPIA going forward.'

For depression NEWMEDS aims to determine why patients respond to antidepressants differently.  Individual academic groups and companies have tried to find out in the past but limited data has deterred progress.  By pooling together resources of public sector projects GENDEP and GenPod with trials from the pharmaceutical companies, NEWMEDS has brought together data on genetics and clinical response in over 1800 patients to form the world’s largest resource of its kind for depression.  Prof Peter McGuffin, GENDEP lead from IoP at King’s comments: 'NEWMEDS has facilitated an unprecedented collaboration between academia and industry on the pharmacogenetics of depression that finally gives us a big enough, powerful enough sample to address how genetics influences antidepressant response. This could lead to changes in the way we select patients for trials, and in the long run how we select treatments for individuals.'

Prof Jonathan Rabinowitz, Bar Ilan University, Israel, who is leading the analysis of the schizophrenia data said:  'For 50 years we have been doing trials the same way – with a standard placebo or active control, for 4-6 weeks and using the same statistical approaches. By bringing together this large dataset we have a unique opportunity to see whether patients who get better on placebo are somehow different. We will be able to identify if trials could be smaller, faster and can decrease exposure of patients to experimental medications.'

Dr. Michel Goldman, Executive Director of the IMI programme adds: 'Acting as a neutral third party, the Innovative Medicines Initiative supports and facilitates the collaboration between public and private partners. The achievements of the NEWMEDS project underline the success of this innovative approach. The academic community will greatly benefit from the partnership, as the exceptionally large and valuable database on schizophrenia will be made available to all participants in the project. IMI has already launched 15 collaborative projects in different disease areas. In October, IMI launched another call for proposals that will result in a new set of research and training projects.'

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