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Sally Okun explains the new research collaboration with the FDA

Yesterday, we announced a new research collaboration with the U.S. Food and Drug Administration (FDA) that will explore how patient-reported data can lead to new insights about drug safety. It’s the first time the FDA will analyze patient-generated data for pharmacovigilence (aka drug safety). But we’re no strangers to drug safety. Check out some of the previous work the community has helped to drive: PatientsLikeMe Offers Adverse Event Reporting for MS Patients Improving drug safety through the patient voice PatientsLikeMe and UCB open free online community for people with Epilepsy in the U.S. To learn more about this new (and unprecedented) collaboration, we talked to our very own Sally Okun, Vice President of Advocacy, Policy and Patient Safety. What will this collaboration do? Patients’ lives and well-being often depend upon medical products approved and regulated by the FDA. But most of the information we see on safety labels comes from clinical trials, which aren’t typically representative of the actual populations of patients who will take the medication. Working with us, the FDA will be able to see the real-world impact of taking medications over time, which can help identify benefits and risks earlier. The FDA isn’t just talking about patient-centricity; …

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Sally Okun reports back from the FDA Patient-Focused Drug Development Public Meeting on IPF

On September 26th I was at the FDA for the Patient-Focused Drug Development Public Meeting on IPF. This is one of 20 meetings that the FDA is holding to learn directly from patients and their caregivers about daily life with the specific condition’s symptoms and treatments. (You can learn more about these meetings here.) I have attended a number of these meetings and often have meaningful data to share from our own PatientsLikeMe members. So far, however, the FDA has only allowed patients and caregivers to present and participate as panelists. So to get as much of our members’ real-world health data in front of the FDA as possible, I take full advantage of the public comment period at the end of each meeting. It’s a short 3-5 minutes of time, but it’s a chance to share insights from PatientsLikeMe members and to reflect on some of what’s been discussed during the public meeting. In addition, we submit a full report to the FDA’s public docket that is open for comment two full months following the meeting. The report includes a community profile and the results of any polls PatientsLikeMe members have taken part in prior to the meeting. This meeting was …

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Improving drug safety through the patient voice

At PatientsLikeMe we’re interested in bringing the voice of our patients to the attention of those who make drug products and to the regulators that approve them. Since 2008 we have conducted a series of projects to collect safety information from some of our member communities. We’ve worked with our pharmaceutical partners to help them better understand the safety experiences of patients while they are using certain drug products. I’d like to introduce you to a new acronym – P.R.O.S.P.E.R.  It stands for Patient-Reported Outcomes in Safety Event Reporting and it promotes the value of including patient experiences in monitoring the safety of drug products during clinical trials and after drugs are approved. The PROSPER Consortium is co-led and supported by PatientsLikeMe and Pope Woodhead, a UK healthcare firm, with input from most global pharmaceutical companies, many clinical and academic groups, as well as regulators, researchers and patient advocates. A report from the Consortium was recently published in the journal Drug Safety that provides guidance for using patient reported outcomes (PROs) for safety monitoring processes. These are just a few of the reports findings… The patient perspective is an essential component of drug safety Patient-centeredness and patient safety are emerging …

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NurseTogether.com partners with PatientsLikeMe

    Media Contact Steve Curtin Vice President NurseTogether.com +1 508.494.0776 stevec@nursetogether.com November 20, 2013, Charlotte, NC — NurseTogether.com, one of the premier online communities for nurses, today announced it has signed a marketing partnership with the patient network PatientsLikeMe to support and promote the importance of the nurse-to-patient care relationship. The websites will share content such as blog posts, articles and speeches on patient-related issues. “The foundation of our modern healthcare system has been built on the strong relationship between the nursing community as primary caregivers and the patients they serve,” said Jenny SolCruz, Vice President of Community at NurseTogether.com. “With this agreement, we’re empowering nurses with a wealth of information and resources that will help better manage the challenges they face every day.” PatientsLikeMe unites people living with chronic diseases and conditions online so they can track their health, learn more about disease, and connect with others. “We’re excited to help those at the very forefront of quality care learn from a wider range of patient experiences,” said Sally Okun RN, Vice President of Advocacy, Policy and Patient Safety at PatientsLikeMe. “Connecting our communities online will create a powerful resource for both nurses and patients.” About NurseTogether.com Based in …

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