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Innovative Medicines Initiative launches novel trial design in Alzheimer’s trial

Friday, December 13, 2013

The Innovative Medicines Initiative (IMI) is launching a major new project that will pioneer a novel, more flexible approach to clinical trials of drugs designed to prevent Alzheimer’s disease. The $72.7 million project, which will see several biotechnology and pharmaceutical companies working closely together, will aim to speed up drug development and patient access to the latest treatments.

The number of people affected by Alzheimer’s worldwide is expected to reach 100 million by 2050, yet despite intensive efforts over many years, there still is no cure for Alzheimer’s and little in the way of treatments.

The new project will focus its efforts on improving the system of “proof-of-concept” studies, early stage clinical trials in which researchers seek to determine if a candidate drug is safe and has an impact on the disease in humans. Currently, companies carry out these trials individually. Each trial is expensive, lasts several years and may require thousands of patients, half of whom are treated with a placebo.

The new project will test a new way to run these proof-of-concept trials, in which several candidate drugs are simultaneously compared to a placebo. In this scenario, only about 20% of patients are in the placebo group, compared to 50% in conventional trials. Furthermore, this novel “adaptive” trial design allows researchers to adapt the trial design in response to emerging results. For example, if a candidate medicine appears to be particularly effective in only certain categories of people, then assignment of that medicine can be preferentially directed to those people to confirm this finding. Similarly, new candidate drugs can be added to the trial and medicines that prove ineffective can be dropped. In addition, this design allows researchers to test both individual drugs and combinations of different medicines.

This innovative trial design has already been found to be effective for testing new treatments for breast cancer. This will be the first time such an approach will be used for Alzheimer’s.

Michel Goldman, IMI executive director, said, “The challenge of developing new treatments for Alzheimer’s is too great for any single organization, country or company to tackle alone. What is needed is an unprecedented, international, collaborative approach bringing together all stakeholders involved in the development of new treatments for Alzheimer’s. As a public-private partnership experienced in running large-scale projects of this nature, IMI is the ideal platform to launch this new project that will hopefully deliver immense benefits for patients.”

The Alzheimer’s project forms part of IMI’s 11th Call for proposals, being launched in mid-December and giving researchers and experts from academia, small businesses, regulatory authorities and patient organizations the opportunity to apply to be part of new projects in a range of fields.

The project has a proposed budget of $72.7 million, $38.4 million of which comes from the European Commission’s Seventh Framework for Research (FP7), and $34.3 million of which comes from in kind contributions by the pharmaceutical companies participating in the project.

With a $2.7 billion budget, the Innovative Medicines Initiative (IMI) is the world’s largest public-private partnership in health. Through collaborative projects that unite experts from industry, academia, small and medium-sized enterprises (SMEs), patient groups and regulators, IMI is developing tools and technologies to speed up the development of safer and better drugs for patients.

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