Wednesday, 12 July 2017

New Clinical Trials

REGAIN - an opportunity for people with hearing loss to take part in a clinical trial.

A team of researchers and clinicians at UCL’s Ear Institute and the Royal National Throat Nose and Ear Hospital are inviting people with hearing loss to participate in a ground breaking clinical trial to test a new drug treatment for hearing loss.

Currently the only option for people with inner ear hearing loss is to wear a hearing aid, or, for those with severe to profound hearing loss, a cochlear implant. These devices help people to communicate, but do not treat the underlying cause of their hearing loss. With one in six people in the UK having hearing loss, there is an urgent need for new treatments. The researchers of the REGAIN project (REgeneration of inner ear hair cells with GAmma-secretase Inhibitors) have worked for years to develop a new drug that could regenerate inner ear (cochlear) hair cells, and they are now at the stage of testing if the drug is safe to use and if it affects the ability to hear in people.

Testing new treatments

New drugs that could potentially treat hearing loss must first be tested in clinical trials. To test a drug in people for the first time, a ‘first-in-man’, or phase I, study is conducted. The aim is to test how safe the drug is in a small group of people. Once this has been proven, the next step is to test the drug in a larger group of people, to see if the drug works and to continue monitoring its safety. This is a phase II study.

The development of new treatments and testing in clinical trials is carefully watched over by the health regulatory authorities and requires their approval to proceed. This is in line with UK and EU law and best practice guidance that governs how clinical trials are designed and conducted.

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