An international consortium of pharmaceutical companies and academic institutions has created a massive database of clinical data that researchers hope can lead to better treatments for schizophrenia and depression.
The collaborative group, called NEWMEDS (Novel Methods Leading to New Medications in Depression and Schizophrenia), has pooled data from 67 trials on 11 compounds in more than 25 countries—creating the largest single database of clinical trial data ever amassed in psychiatric research—to help devise new ways to predict which treatment is likely to work for which patient, rather than using the standard trial-and-error approach for everyone.
“For 50 years we have been doing trials the same way with a standard placebo or active control for four-to-six weeks and using the same statistical approaches,” said Jonathan Rabinowitz, a professor at Bar Ilan-University in Israel, who is leading the analysis of the schizophrenia data. “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.”
The NEWMEDS project, which consists of 19 industry and academic institutions based in nine different European Union member states as well as in Iceland, Switzerland and Israel, was founded in September 2009 to address barriers for the development of drugs for psychiatric disorders. Despite the growth in biomedical knowledge in recent years, the rate of new drugs for depression and schizophrenia has been slow.
According to a recent PhRMA report, 313 drugs are being developed in the United States for psychiatric disorders, including 71 for depression and 54 for schizophrenia, yet most are reformulations of existing compounds or new chemical entities (NCEs) that use existing mechanisms of action.
During the past year, NEWMEDS has begun to address two of the main barriers that have been identified to developing new psychiatric drugs: the competitive relationship between rival companies and the limited exchange of science across the industry-academic divide. “The pharmaceutical industry model where each company in isolation tries to solve pre-competitive problems is being challenged by NEWMEDs,” said Tine Bryan Stensbøl, Ph.D., NEWMEDS’ industry lead and coordinator.
In the area of depression, the NEWMEDs partnership aims to determine why some patients respond to one kind of antidepressants and others do not. A key advantage of the academic-industry collaboration is its ability to combine clinical data and samples from previous pharmaceutical company studies and public sector projects in a novel way. The project already has pooled data on the genetics and clinical response in more than 1,800 patients.
“It gives us a big enough, powerful enough sample to address how genetics influences antidepressant response,” said Peter McGuffin, a professor at the Institute of Psychiatry at King’s College in London. “This could lead to changes in the way we select patients for trials and, in the long run, how we select treatments for individuals.”
Although sharing data already has led to new discoveries in the field of genetics, NEWMEDS is the first large-scale example of a similar collaboration between industry and academia in the field of psychiatry.
“We wanted to see how this could be done in the clinical area,” said Shitiju Kapur, a professor at the Institute of Psychiatry at King’s College and NEWMEDS’ academic leader. “Hopefully, this will be one step that will help reverse the drought of new medications in psychiatry.”
The NEWMEDS consortium was brought together by the Innovative Medicines Initiative, a public-private partnership between the European pharmaceutical industry and the European Union. Pharmaceutical companies involved in the project include AstraZeneca, Eli Lilly, Johnson & Johnson’s Janssen Pharmaceutica, Lundbeck, Novartis, Orion, Pfizer, Roche and Servier.