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 as core elements of any responsive health system
- The potential clinical utility and value of real-world information obtained from real patients taking real drugs is great1
Although the U.S. Food and Drug Administration (FDA) has accepted safety reports from consumers for 20 years through its MedWatch program, other parts of the world only accept reports on adverse reactions to drugs from health professionals. While patient reporting has recently been encouraged there remain skeptics who doubt its value.
PatientsLikeMe is part of the PROSPER Consortium because we believe the patient voice – your voice – is essential to improving the safety of drugs and medical products. As we look ahead to 2014, we’ll be exploring opportunities to amplify your voice across all areas of health care to improve safety, starting with the FDA and the EU counterpart, the European Medicines Agency.