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FDA links with PatientsLikeMe

Published on 16/06/15 at 07:56am
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The US Food and Drug Administration has signed a research deal with PatientsLikeMe in a move the online patient network described as ‘unprecedented’.

The collaboration seeks to establish how patient-reported data might help the FDA make decisions in areas involving the management of risk and drug safety.

PatientsLikeMe has 350,000 members with 2,500 conditions who report on their real-world experiences: it began a pilot programme in 2008 allowing patients with multiple sclerosis to report adverse events directly to the FDA, followed by the first drug safety platform on social media.

It is this database of 110,000 adverse event reports on 1,000 different medications that the FDA will now be able to mine in addition to its more usual caches of information. 

“Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world,” explains PatientsLikeMe co-founder and president Ben Heywood. 

The idea is that patient-generated data gives a more rounded picture of a drug’s safety by offering a window into patients’ day-to-day interaction with their treatment, providing “important real-time insights into the nuances inherent in patients’ experiences over time, including drug tolerance, adherence and quality of life”. 

While manufacturers must report adverse events to the FDA, doctors and patients do not have to do so. “We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier,” Heywood continues.

The relationship between the FDA and patients is a complex one: the regulator came under fire this week when it was criticised by consumer watchdog Public Citizen for incorrectly expanding the use of Vanda Pharma’s sleep disorder drug Hetlioz – and not correcting its mistake.

PatientsLikeMe has hooked up with the FDA on projects before, but the new collaboration – announced at the start of the Drug Information Association’s (DIA) annual meeting in Washington D.C. - marks its greater involvement in the regulatory science process. 

The patient group has worked with a range of other US institutions, including the Institute of Medicine, the National Institute of Health, the Centers for Disease Control and Prevention, the Department of Health and Human Services, and not-for-profit organisations such as the Patient Centered Outcomes Research Institute (PCORI).

Adam Hill

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