U.S. FOOD & DRUG ADMINISTRATION
Center for Drug Evaluation and Research (CDER) Crowdsourcing Site
Send Your Pediatric Research Questions to FDA
Are you a clinician, researcher, drug developer, patient, or patient advocate with interesting ideas for pediatric research questions for FDA staff to pursue by analyzing pooled clinical trial data (data from multiple clinical trials) submitted to the FDA for regulatory purposes? If so, learn more about this initiative, see what others have submitted, or submit a research question of your own by September 3rd.

Send your pediatric research questions

FDA has access to a large database of trial data from over 1,600 pediatric clinical trials and related trials in adults. FDA generally cannot publish research about individual products or share patient-level data with external stakeholders; however, FDA staff may conduct and publish pooled analyses of these data.

Over the past several years, Division of Pediatrics and Maternal Health (DPMH) staff, in collaboration with Office of New Drugs review divisions and other offices, have published numerous pooled analyses that have advanced pediatric regulatory science. DPMH seeks research questions with substantial potential to accelerate or inform pediatric drug development that can be addressed using data submitted to the FDA.

At the end of the submission period on September 3rd, all submitted ideas will be reviewed by DPMH to determine if one or more may be selected as internal research projects led by FDA scientific staff. Individuals who submit research questions will not obtain data access or collaborate in any new research studies initiated by FDA.

Frequently Asked Questions

This online forum is a way for you to share your thoughts and interact with others in the community. Here are some frequently asked questions about participating on this site.

Crowdsourcing provides an opportunity for interaction and communication across the FDA and the public. Crowdsourcing community members can engage with each other and the FDA by sharing their experiences and commenting on the experience of others. These conversations create an avenue for the FDA to listen to the public and incorporate their perspectives into ongoing initiatives.

Once you are logged-in, click the "Submit Research Question" button on the top right-hand corner of the page.

You can also view what others have submitted by clicking the "See what others have to say" button.

Yes!

  1. Click on your username in the top right-hand corner and select. "Profile"
  2. Scroll down to "Community Identities" and check the box under "Hidden Identity" in the row labeled "DPMH Crowdsourcing."
  3. Click the "Save Changes" button above the Community Identities section. (Be careful to not click the "Leave" button as this will remove you from the community).
  4. To confirm that your identity is hidden, leave the profile page by clicking on the home icon at the top of the page and then revisit it by following steps 1 & 2 above. The "Hidden Identity" box should still be checked. (There is a known bug that shows the "Hidden Identity" checkbox as unchecked after you click the "Save Changes" button. Refreshing the page may not work to confirm your changes are saved, which is why leaving the page is recommended.)

You can also participate anonymously by turning on the "submit idea anonymously" before submitting your post.

  1. Click the "Submit Research Question" button on the top right-hand corner of the page.
  2. Fill out the required fields.
  3. Scroll to the bottom of the submission page and turn on the "Submit Idea anonymously" button prior to submitting your post.

Please note that no matter what option you choose to participate anonymously, you will still see your name attached to your shared experiences. However, the rest of the community will only see "Community Member" instead of your name.

The information gathered in your registration will not be shared and is only used for log-in and verification purposes.

The information you submit and the comments you post will be used to understand the relationship between community participants and pediatric research.

Please do not post any personally identifiable information (PII) (such as address, social security number, etc.).

This site is moderated by the staff in the Center for Drug Evaluation and Research within the U.S. Food and Drug Administration (FDA).

Moderators will facilitate discussions and work to ensure that posts remain respectful. Please be advised that moderators may not always monitor discussions in real time. Due to the potential volume of comments, moderators may not respond to all posts.

FDA staff is here to get a better understanding of what you think FDA scientific staff should research using pooled analyses of oncology clinical trial data. If you have specific questions, we encourage you to share them via email with our FDA staff at ShareYourVoice@fda.hhs.gov.