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Shining a light on IMI’s dedication to the clinical trials process

The Innovative Medicines Initiative’s work on expanding the use of big and real world data has been well documented – not least on this website. While big data is an extremely important part of the future direction of medical research, this does not mean that the clinical trial (CT) is a thing of the past.

As we celebrate International Clinical Trials Day on 20 May 2016, it is worth pointing out that IMI – the world’s largest public-private partnership in the Life Science’s sector – is well aware of the value of CTs and has therefore instituted a number of projects to improve how they are conducted.

Let’s begin with the fundamentally important issue of trial design.

Novel Methods leading to New Medications in Depression and Schizophrenia (NEWMEDS) is a unique project that partners top scientists with nearly all the world’s major medicines manufacturers. The NEWMEDS project shed new light on the underlying causes of schizophrenia and depression, developed new tools to aid in the development of new drugs to treat these conditions, and proposed new, more efficient ways of carrying out clinical trials for new treatments. NEWMEDS also demonstrated that early clinical trials of potential medicines for schizophrenia could be made shorter and more efficient by including more women, more people with certain types of symptoms, and younger patients.

The European prevention of Alzheimer’s dementia (EPAD) consortium is pioneering a new approach to Alzheimer’s disease, by using adaptive clinical trials, in which several candidate drugs are simultaneously compared to each other and to a placebo. This means more patients should benefit from a potentially active treatment. Furthermore, researchers are able to adapt the trial design in response to emerging results. Already proven effective in testing new treatments for breast cancer, the hope is that in Alzheimer’s it will help identify ineffective medicines earlier in drug development, and so avoid failures in more advanced (Phase III) trials.

GetReal looks at incorporating real-life clinical data into drug development.

If successful, this should: help pharma companies take better decisions during drug development; support healthcare decision makers when deciding how best to grant patients access to a new treatment.

We turn now to tools that support better trials.

The DIRECT project seeks to identify different subtypes of type 2 diabetes and determine the most appropriate treatments for them. It focuses partially on patient stratification – establishing different subgroups of patients – and aims to develop and validate tests to predict who will get diabetes, whose condition will deteriorate rapidly after diagnosis, and what the response will be to specific drugs. Ultimately, the tests developed by DIRECT will usher in a new era of personalised medicine for diabetes patients.

EHR4CR – Electronic Health Records Systems for Clinical Research – will build a platform to support the use of these records to make medical research more efficient and will run pilot projects (on e.g. interoperability, security, data quality, data storage solutions) to demonstrate the viability and scalability of an EHR4CR business model. The European Medical Information Framework (EMIF) will develop a common information framework of patient-level data that will link up and boost access to diverse medical and research data sources. The aim is to open up new avenues of research for scientists. These two approaches will ultimately help identifying patients for trials, not only speeding recruitment of patients, but also targeting the right patient.

IMI also contains exciting programmes that conduct trials on medicines.

New Drugs 4 Bad Bugs (ND4BB) is responsible for an unprecedented partnership between industry, academia and biotech organisations with the aim of addressing antibiotic resistance in Europe. It sets up a network of specialised clinical trials centres that can be mobilised as soon as a new molecule is ready for testing. The programme also addresses novel ways of conducting trials with antibiotics and their combinations. Several trials currently are being conducted to accelerate the development of new classes of antibiotics.

The IMI Ebola+ programme, launched in response to the Ebola outbreak that started in western Africa in 2014, complements efforts to tackle a wide range of challenges in Ebola research, including: vaccines development; clinical trials; storage and transport; diagnostics; and treatments. Eight projects were selected for funding under the first Ebola+ Call, with a second open Call on Ebola and related diseases launched in December 2015. Four of them conduct trials with anti-Ebola vaccines, aiming to accelerate their development so we are ready for any future outbreak.

Finally we have EUPATI, a jewel in the crown of patient engagement facilitation. A patient-led initiative that aims to develop the first European Patients’ Academy on Therapeutic Innovation lays bare the medical R&D process. It runs training courses, publishes educational material and hosts an online public library that will empower well-informed patients to engage more effectively in the development and approval of new treatments and become true partners in pharmaceutical R&D.

Far from leaving Clinical Trials Behind to focus on big data, IMI is honing the trial to make it more efficient, more accessible and more productive.

Magda Chlebus

Magda Chlebus, Executive Director of Science Policy & Regulatory Affairs at the European Federation of Pharmaceutical...
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