PatientsLikeMe and the FDA Sign Research Collaboration Agreement

WASHINGTON D.C., June 15, 2015—PatientsLikeMe and the U.S. Food and Drug Administration (FDA) have signed a research collaboration agreement to determine how patient-reported data can give new insights into drug safety. Under the collaboration, PatientsLikeMe and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management. The announcement was made at the start of the Drug Information Association’s (DIA) annual meeting in Washington D.C.

PatientsLikeMe Co-Founder and President Ben Heywood said the agreement is an unprecedented step toward enhancing post-market surveillance and informing regulatory science. “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. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time. We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”

The cornerstone of the FDA’s post-approval drug safety surveillance is a spontaneous reporting system consisting of individual case safety reports. Reporting adverse events to the FDA is mandatory for drug product manufacturers but voluntary for healthcare professionals and patients. The majority of these individual case safety reports are submitted by healthcare professionals and patients to drug product manufacturers, who then have regulatory requirements to report them to the FDA. The PatientsLikeMe data are generated in a different context by patients themselves, and provide important real-time insights into the nuances inherent in patients’ experiences over time, including drug tolerance, adherence and quality of life.

PatientsLikeMe is the largest and most active patient network online, with 350,000 members reporting on their real-world experiences with more than 2,500 conditions. The company’s drug safety initiatives began in 2008 with a pilot program that allowed patients living with Multiple Sclerosis (MS) to report adverse events directly to the FDA. One year later the company launched the first drug safety platform on social media, enabling industry partners to meet their regulatory obligations. In all, PatientsLikeMe has collected more than 110,000 adverse event reports on 1,000 different medications, data that the FDA will now be able to access and analyze as a supplement to traditional sources, including FAERS.

While this is the first time that PatientsLikeMe has formally worked with the FDA, the collaboration adds to a foundation the company has built as an active participant in the regulatory science process. PatientsLikeMe has worked with, provided counsel to and co-authored discussion papers with a range of government groups, including the Institute of Medicine, the National Institute of Health, the Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services, as well as nonprofit organizations such as the Patient Centered Outcomes Research Institute (PCORI).

About PatientsLikeMe
PatientsLikeMe® ( is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services and care. With more than 350,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 60 peer-reviewed research studies. Visit us at or follow us via our blog, Twitter or Facebook.

About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Margot Carlson Delogne
(781) 492-1039

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4 thoughts on “PatientsLikeMe and the FDA Sign Research Collaboration Agreement”

  1. This collaboration with the FDA could yield valuable data – but when I asked your representative for additional details such as who is funding this collaboration, who will have access to the data, and how will the patient information be used so I could write about it in my blog, I was told I could not have access to the contract with the FDA or any additional details. I got an official reply from the FDA Trade Press office that read:

    “We are able to share with you an abstract of the agreement with PatientsLikeMe. We are unable to provide the full agreement because it is considered business confidential. The terms of the Research Collaboration Agreement (RCA) and Cooperative Research and Development Agreements (CRADA) are considered business confidential and would generally be considered this by the Freedom of Information Act (FOIA) offices. There is no time limit to this business confidential status. However, the final decision in a request under FOIA comes from the FOIA office. You may request a copy of the full agreement from the FOIA office. Instructions on making a FOIA request from FDA is available here:”

    The abstract sent to me was merely a brief few lines and provides little information other than this agreement was signed in April 2015, “PLM provides real-world patient insights and longitudinal patient-reported data to various stakeholders from industry, government agencies, researchers through strategic collaborations and partnerships” and this collaboration might “drive insights about patient behavior and experience with post market use of FDA regulated medical products, as well as report of adverse events. The proposed work will be conducted in two phases:
    Phase 1: Novel Patient-Generated (PatientsLikeMe) Data Analysis and Evaluation
    Phase 2: Collaborative Design and Planning of Research projects.”

    Anyone who understands how research is funded these days in the United States knows the funds from the FDA and NIH have shrunk, and we are dependent on private industry (pharmaceutical companies) for the development of new therapies. Even academic researchers struggle due to the lack of research funding. Which brings me back to the question of who is funding this initial research and who will use the information that is generated and in what ways? How these research projects are going to be planned and conducted using patient data should be shared up front.

    I have no problem with your business model of getting people to share their information so you can sell it for research purposes and you have always made this purpose of PLM clear in your terms of use section. PLM always operated with great transparency about its business relationships and it is disappointing that there is now this deviation from openness with the patients who have built the foundation of your enterprise.

    I respectfully again request that additional details about this collaboration between Patients Like Me and the FDA be shared so people can make an informed decision as to whether they wish to give their information freely for this use. I should not have to file a Freedom of Information Act request to find the answers to my questions.


    1. PatientsLikeMe

      Hi Laura,

      Thank you for reaching out. We understand that you’ve been in contact with the FDA and it looks like they’ve been able to provide you with the information you were seeking. But just to help clarify, even though PatientsLikeMe is sharing the data at no cost, the use of patient data may lead to 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.

  2. Informative article . I was fascinated by the info – Does someone know where my company might be able to get ahold of a blank CA FL-330 form to work with ?

  3. Pingback: The Patient Experience in Tomorrow’s Clinical Trials - PRC Clinical

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