US FDA teams with PatientsLikeMe to access post-market patient data

By Dan Stanton contact

- Last updated on GMT

US FDA will use patient data supplied by PatientsLikeMe to monitor post-market adverse events
US FDA will use patient data supplied by PatientsLikeMe to monitor post-market adverse events

Related tags: Risk

PatientsLikeMe says a deal allowing the US FDA to use its patient-generated data is an “unprecedented step toward enhancing post-market surveillance.”

The collaboration will help the US Food and Drug Administration (FDA) review activities related to risk assessment and risk management in approved drugs post-launch using data provided by the patient group.

Phase IV trials give regulators better insight into the potential adverse events of drugs in a post-market setting, but these studies are only based on a few hundred or thousand patients, PatientsLikeMe President Ben Heywood said.

“We are not running clinical trials,”​ he told this publication. “This collaboration is about post-market surveillance and understanding more about the data that patients are reporting on our open network, and exploring opportunities to learn more about drug safety.”

Furthermore, he continued, PatientsLikeMe is an open network and “the data come from patients who are reporting on their experiences in the real world, and are not influenced by pharma companies or CROs.”

He continued:“Our members are already syncing FitBit data on their PatientsLikeMe profiles and checking in to tell us how they are doing using PatientsLikeMe’s mobile application. However, today, our members use the website - via mobile and browsers - to report side effects and adverse events.”

The deal was announced at the Drug Information Association’s (DIA) annual meeting in Washington today, with the FDA’s willingness to evaluate new data source described by PatientsLikeMe as an “unprecedented step toward enhancing post-market surveillance and informing regulatory science.”

While the FDA is not paying for this data, Heywood said the project could “lead to future FDA-sponsored research projects designed to understand how patient-reported data might be used to enhance post-market surveillance, support regulatory decision making and inform regulatory science.”

Related news

Show more

Related products

show more

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 01-Nov-2021 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

Automating clinical trials for success

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 15-Jul-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

Related suppliers

Follow us

Products

View more

Webinars