FDA, CTTI seeking members for new patient engagement collaborative

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/g-stockstudio)
(Image: Getty/g-stockstudio)

Related tags: Medicine, Food and drug administration

The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.

The US Food and Drug Administration (FDA) has tapped the Clinical Trials Transformation Initiative (CTTI)  to support its Patient Engagement Collaborative.

CTTI is a public-private partnership co-founded by Duke University and the FDA with the goal of increasing the quality of clinical trials.

The new collaborative will be an ongoing forum through which the patient community and regulators will discuss communication, transparency, and new ways for patients and the FDA to work together, explained Zachary Hallinan, CTTI project manager.

The FDA is seeking nominations​ to join the Patient Engagement Collaborative through January 29, 2018.

CTTI and the FDA believe that furthering the engagement of patients as valued partners across the research and development continuum requires an open forum for patients and regulators to discuss and exchange ideas​,” Hallinan said.

Creation of the collaborative follows public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA).

As part of this feedback, Hallinan explained that it was suggested an outside group be created to provide input on patient engagement.

The goal in creating this collaborative is to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products​,” he added.

Engaging patients as partners in the development of medical products is critical to the success of the clinical research enterprise​.”

Related news

Show more

Related products

show more

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...

Empowering Clinical Trial Sponsors with Analytics

Empowering Clinical Trial Sponsors with Analytics

PerkinElmer | 14-Jul-2021 | Technical / White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

Related suppliers

Follow us

Products

View more

Webinars